Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Lifescapes System in Post-stroke Hand Recovery

20. august 2026 opdateret af: National University Hospital, Singapore

Effectiveness and Feasibility of a Brain-computer Interface Based Neurofeedback System With Reduced Therapist Supervision for Hand Motor Recovery in Stroke Patients

Stroke is a leading cause of long-term disability, with 30-60% of survivors remaining unable to use their affected arms after discharge. Existing rehabilitation approaches such as motor imagery, robotic assistance, and neuromodulation have shown limited effectiveness for hand motor recovery. The Lifescapes system is a novel EEG-based brain-computer interface that combines motor imagery practice, biofeedback, neuromuscular electrical stimulation, and robotic assistance to help post-stroke patients with severe hand paralysis. A recent clinical trial in 40 patients demonstrated promising improvements in motor function with the Lifescapes system, supporting its potential as a rehabilitation tool.

This study aims to evaluate whether Lifescapes therapy delivered with reduced therapist supervision can improve upper-limb motor function in stroke patients, and whether such an approach is operationally feasible in the local clinical setting.

32 participants will be recruited from Alexandra Hospital and National University Hospital over 2 years.

Participants must be aged 21-80, have had a stroke between 8 weeks and 5 years before enrolment, and have moderate to severe upper-limb impairment. They must be able to give informed consent and follow instructions. Participants are excluded if they are pregnant, have bilateral stroke, severe finger spasticity (MAS >2), implanted stimulators or pacemakers, recent seizures within 90 days, or any unstable medical conditions.

Participants will complete 16 sessions of Lifescapes BCI training over 4-8 weeks (2-4 sessions per week, approximately 30 minutes each). Therapist assistance will be progressively reduced based on each participant's ability, though a therapist remains present throughout. Each Lifescapes session is followed by a 30-minute GRASP session, a standardised self-directed arm and hand exercise programme prescribed by an occupational therapist.

Participants will attend up to 21 visits over 5-6 months. Outcomes are assessed at 6 timepoints: pre-baseline (2-4 weeks before starting), baseline, after the 8th session, after the 16th session, and at 1-month and 3-month follow-up (the latter optional). Outcome measures include the Fugl-Meyer Assessment for the upper extremity (FMA-UE), Action Research Arm Test (ARAT), grip and pinch strength, Modified Ashworth Scale (MAS), Motor Activity Log-14 (MAL-14), EQ-5D-5L quality of life measure, and optional TMS measurement of corticospinal excitability.

Studieoversigt

Status

Status

Angiver den aktuelle rekrutteringsstatus eller den udvidede adgangsstatus.
Ikke rekrutterer endnu

Betingelser

Betingelser

Den sygdom, lidelse, syndrom, sygdom eller skade, der undersøges. På ClinicalTrials.gov kan tilstande også omfatte andre sundhedsrelaterede problemer, såsom levetid, livskvalitet og sundhedsrisici.

Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.

Detaljeret beskrivelse

Background

Stroke is a leading cause of adult long-term disability, with 30-60% of stroke survivors remaining unable to use their affected arms after discharge. While many interventional approaches have been tested - including motor imagery, robotic movement assistance, and neuromodulation - therapeutic efficacy remains limited for hand motor function. The Lifescapes system is a novel EEG-based brain-computer interface (BCI) neurofeedback system that facilitates motor imagery practice in post-stroke patients with severe hemiparesis, integrating biofeedback, neuromuscular electrical stimulation (NMES), and robot-aided sensorimotor stimulation. By triggering NMES and robotic assistance contingent on sensorimotor rhythm event-related desynchronisation (SMR-ERD) magnitude, the system enables voluntary modulation of endogenous sensorimotor activities in the ipsilesional hemisphere. A recent RCT in 40 chronic post-stroke hemiplegic patients demonstrated a significant between-group difference in Fugl-Meyer Assessment scores in favour of the Lifescapes group, supporting its potential as an adjunctive rehabilitation approach.

Study Objectives

The primary objective is to evaluate the effectiveness of Lifescapes therapy with reduced therapist supervision in improving upper-limb motor function in sub-acute and chronic stroke patients with moderate to severe upper limb paresis. The secondary objective is to evaluate the operational feasibility of Lifescapes with reduced therapist supervision in the local context. It is hypothesised that Lifescapes therapy with reduced therapist supervision is feasible in this study population and will quantitatively improve hand motor function.

Study Design

This is a single-arm, prospective study to evaluate the real-world effectiveness and feasibility of Lifescapes with reduced therapist supervision for post-stroke upper-limb rehabilitation. 32 subjects will be recruited from Alexandra Hospital (AH) and National University Hospital (NUH) over an estimated study duration of 2 years.

Participants

Inclusion criteria are: age 21-80 years; first-ever or recurrent ischemic or haemorrhagic stroke; stroke onset between 8 weeks and 5 years prior to enrolment; moderate to severe unilateral upper-limb motor impairment defined as a baseline FMA-UE score <47 and Manual Muscle Testing (MMT) of finger extensor ≤2; ability to provide informed consent and follow verbal instructions; and sufficient visual acuity to scan a full computer screen.

Exclusion criteria include: pregnant or breastfeeding women; bilateral stroke; Modified Ashworth Scale (MAS) of finger flexors >2; use of a pacemaker or other implanted stimulators; history of seizures within 90 days before enrolment; inability to record EEG due to skin status or skull deformity; sensorimotor disturbance due to causes other than stroke; and medically unstable or uncontrolled conditions that may compromise safety or the ability to complete scheduled visits.

Intervention

Eligible subjects will undergo 16 sessions of MI-BCI training with NMES and robotic movement assistance using the paralysed hand through the Lifescapes device. The intervention course must be completed within 4-8 weeks from the first to the last session, at a target frequency of 2-4 sessions per week. Therapist assistance during each Lifescapes session will be reduced progressively according to individual ability, though a therapist will remain present throughout in case assistance is needed. Each session is approximately 30 minutes.

Following each Lifescapes session, participants will complete a standardised occupational therapy programme - GRASP (Graded Repetitive Arm Supplementary Program) - supervised by a trained research staff member. All occupational tasks will be selected from the GRASP task pool and prescribed by an occupational therapist. Each GRASP session will take approximately 30 minutes.

Study Visits and Assessments

There will be up to 21 study visits over 5-6 months, comprising 16 intervention sessions and 6 rounds of assessment at the following timepoints: 2-4 weeks before the first Lifescapes session (pre-baseline), before the first session (baseline), after the 8th session (interim), after the 16th session (post), 1 month after the 16th session (1-month follow-up), and 3 months after the 16th session (3-month follow-up, optional).

Outcome Measures

Clinical outcomes assessed at each timepoint include: Upper Extremity Fugl-Meyer Assessment (FMA-UE); Action Research Arm Test (ARAT); grip and pinch strength measured by dynamometer; Modified Ashworth Scale (MAS) of the affected upper limb muscles; Motor Activity Log-14 (MAL-14); EQ-5D-5L; and corticospinal excitability measurement by TMS (optional).

Undersøgelsestype

Undersøgelsestype

Beskriver karakteren af ​​en klinisk undersøgelse. Undersøgelsestyper omfatter interventionelle undersøgelser (også kaldet kliniske forsøg), observationsundersøgelser (herunder patientregistre) og udvidet adgang.
Interventionel

Tilmelding (Anslået)

Tilmelding

Antallet af deltagere i en klinisk undersøgelse. Den "forventede" tilmelding er det mål for antallet af deltagere, som forskerne skal bruge til undersøgelsen.
32

Fase

Fase

Stadiet af et klinisk forsøg, der studerer et lægemiddel eller et biologisk produkt, baseret på definitioner udviklet af U.S. Food and Drug Administration (FDA). Fasen tager udgangspunkt i undersøgelsens formål, antallet af deltagere og andre karakteristika. Der er fem faser: Tidlig fase 1 (tidligere opført som fase 0), fase 1, fase 2, fase 3 og fase 4. Ikke relevant bruges til at beskrive forsøg uden FDA-definerede faser, herunder forsøg med enheder eller adfærdsmæssige indgreb.
  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiekontakt

Navn og kontaktoplysninger for den person, der kan besvare spørgsmål om tilmelding til en klinisk undersøgelse. Hvert sted, hvor undersøgelsen udføres, kan også have en specifik kontaktperson, som kan være bedre i stand til at besvare disse spørgsmål.

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Berettigelseskriterier

De nøglekrav, som personer, der ønsker at deltage i et klinisk studie, skal opfylde eller de egenskaber, de skal have. Kvalifikationskriterier består af både inklusionskriterier (som er nødvendige for at en person kan deltage i undersøgelsen) og eksklusionskriterier (som forhindrer en person i at deltage). Typer af berettigelseskriterier omfatter, om en undersøgelse accepterer raske frivillige, har alders- eller aldersgruppekrav eller er begrænset af køn.

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  1. Age 21-80 years old;
  2. First-ever or recurrent ischemic or haemorrhagic stroke;
  3. Stroke onset between 8 weeks and 5 years prior to enrolment;
  4. Moderate to severe unilateral upper-limb motor impairment following stroke, defined as a baseline upper-extremity Fugal-Meyer Assessment (FMA-UE) score <47, and Manual Muscle Testing (MMT) of finger extensor ≤2;
  5. Being able to provide informed consent, understand and follow verbal instructions.
  6. Having sufficient visual acuity to scan full computer screen.

Exclusion Criteria:

  1. Pregnant or breastfeeding women;
  2. Bilateral stroke;
  3. Modified Ashworth Scale (MAS) of finger flexors >2;
  4. Use of a pacemaker or of other implanted stimulators;
  5. History of seizures within 90 days before enrolment;
  6. Impossible to record EEG because of skin status or skull deformity;
  7. Sensorimotor disturbance due to other causes other than stroke;
  8. Medically unstable or uncontrolled conditions that may compromise safety or the ability to complete scheduled visits.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm

Deltagergruppe / Arm

En gruppe eller undergruppe af deltagere i et klinisk forsøg, der modtager en specifik intervention/behandling eller ingen intervention i henhold til forsøgets protokol.
Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.
Eksperimentel: MI-BCI training with NMES and robotic movement assistance
Eligible subjects will undergo 16 sessions of MI-BCI training with NMES and robotic movement assistance using the paralyzed hand through the Lifescapes device.
Enhed: Lifescapes
Lifescapes device is an EEG-based brain-computer-interface (BCI) neurofeedback system. It was developed to facilitate motor imagery (MI) practice in post-stroke patients with severe hemiparesis who are unable to perform voluntary finger extension, serving as a substitute for actual movement exercise. The system comprises 4 components: standard medical treatments with motor imagery (3), biofeedback (4), neuromuscular electrical stimulation (NMES) to paretic muscles (5), and robot-aided sensorimotor stimulation (6). By integrating these components, the EEG-based BCI system enables voluntary modulation of endogenous sensorimotor activities in the ipsilesional hemisphere by triggering the NMES and robotic device contingent on the sensorimotor rhythm event-related desynchronization (SMR-ERD) magnitude.

Hvad måler undersøgelsen?

Primære resultatmål

Primære resultatmål

I et klinisk studies protokol er det planlagte resultatmål, der er det vigtigste for at evaluere effekten af ​​en intervention/behandling. De fleste kliniske undersøgelser har ét primært resultatmål, men nogle har mere end ét.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Upper Extremity Fugal-MeyerFugl-Meyer Assessment (FMA-UE)
Tidsramme: Week 0 (Pre-baseline assessment)
FMA-UE is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treat. Scores range from 0 to 66, with higher scores indicating better motor function.
Week 0 (Pre-baseline assessment)
Upper Extremity Fugal-MeyerFugl-Meyer Assessment (FMA-UE)
Tidsramme: Week 2 (baseline assessment)
FMA-UE is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treat. Scores range from 0 to 66, with higher scores indicating better motor function.
Week 2 (baseline assessment)
Upper Extremity Fugal-MeyerFugl-Meyer Assessment (FMA-UE)
Tidsramme: Week 5 (Interim-intervention assessment)
FMA-UE is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treat. Scores range from 0 to 66, with higher scores indicating better motor function.
Week 5 (Interim-intervention assessment)
Upper Extremity Fugal-MeyerFugl-Meyer Assessment (FMA-UE)
Tidsramme: Week 8 (Post-intervention assessment)
FMA-UE is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treat. Scores range from 0 to 66, with higher scores indicating better motor function.
Week 8 (Post-intervention assessment)
Upper Extremity Fugal-MeyerFugl-Meyer Assessment (FMA-UE)
Tidsramme: Week12 (1 month after the intervention)
FMA-UE is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treat. Scores range from 0 to 66, with higher scores indicating better motor function.
Week12 (1 month after the intervention)
Upper Extremity Fugal-MeyerFugl-Meyer Assessment (FMA-UE)
Tidsramme: Week 20 (3 months after the intervention)
FMA-UE is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treat. Scores range from 0 to 66, with higher scores indicating better motor function.
Week 20 (3 months after the intervention)

Sekundære resultatmål

Sekundære resultatmål

I en klinisk undersøgelses protokol er et planlagt resultatmål, der ikke er lige så vigtigt som det primære resultatmål for at evaluere effekten af ​​en intervention, men som stadig er af interesse. De fleste kliniske undersøgelser har mere end ét sekundært resultatmål.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Action Research Arm Test (ARAT)
Tidsramme: Week 0 (Pre-baseline assessment)
It evaluates UL motor function and status in standardized format using 19 tests of upper limb motor function across 4 subsets: grasp, pinch, grip, and gross movement, both distally and proximally, following a stroke. The ARAT has a maximum score of 57, with scores ranging from 0 to 57, where higher scores indicate better upper limb function.
Week 0 (Pre-baseline assessment)
Action Research Arm Test (ARAT)
Tidsramme: Week 2 (baseline assessment)
It evaluates UL motor function and status in standardized format using 19 tests of upper limb motor function across 4 subsets: grasp, pinch, grip, and gross movement, both distally and proximally, following a stroke. The ARAT has a maximum score of 57, with scores ranging from 0 to 57, where higher scores indicate better upper limb function.
Week 2 (baseline assessment)
Action Research Arm Test (ARAT)
Tidsramme: Week 5 (Interim-intervention assessment)
It evaluates UL motor function and status in standardized format using 19 tests of upper limb motor function across 4 subsets: grasp, pinch, grip, and gross movement, both distally and proximally, following a stroke. The ARAT has a maximum score of 57, with scores ranging from 0 to 57, where higher scores indicate better upper limb function.
Week 5 (Interim-intervention assessment)
Action Research Arm Test (ARAT)
Tidsramme: Week 8 (Post-intervention assessment)
It evaluates UL motor function and status in standardized format using 19 tests of upper limb motor function across 4 subsets: grasp, pinch, grip, and gross movement, both distally and proximally, following a stroke. The ARAT has a maximum score of 57, with scores ranging from 0 to 57, where higher scores indicate better upper limb function.
Week 8 (Post-intervention assessment)
Action Research Arm Test (ARAT)
Tidsramme: Week12 (1 month after the intervention)
It evaluates UL motor function and status in standardized format using 19 tests of upper limb motor function across 4 subsets: grasp, pinch, grip, and gross movement, both distally and proximally, following a stroke. The ARAT has a maximum score of 57, with scores ranging from 0 to 57, where higher scores indicate better upper limb function.
Week12 (1 month after the intervention)
Action Research Arm Test (ARAT)
Tidsramme: Week 20 (3 months after the intervention)
It evaluates UL motor function and status in standardized format using 19 tests of upper limb motor function across 4 subsets: grasp, pinch, grip, and gross movement, both distally and proximally, following a stroke. The ARAT has a maximum score of 57, with scores ranging from 0 to 57, where higher scores indicate better upper limb function.
Week 20 (3 months after the intervention)
Grip and pinch strength
Tidsramme: Week 0 (Pre-baseline assessment)
Grip and pinch strength will be measured using a hand dynamometer. Grip strength is assessed by asking the participant to squeeze the dynamometer as hard as possible, while pinch strength measures the force exerted between the thumb and fingers. Results are recorded in kilograms or pounds of force. These measures provide an objective assessment of hand and forearm muscle strength, and will be used to track changes in upper limb strength over the course of the study.
Week 0 (Pre-baseline assessment)
Grip and pinch strength
Tidsramme: Week 2 (baseline assessment)
Grip and pinch strength will be measured using a hand dynamometer. Grip strength is assessed by asking the participant to squeeze the dynamometer as hard as possible, while pinch strength measures the force exerted between the thumb and fingers. Results are recorded in kilograms or pounds of force. These measures provide an objective assessment of hand and forearm muscle strength, and will be used to track changes in upper limb strength over the course of the study.
Week 2 (baseline assessment)
Grip and pinch strength
Tidsramme: Week 5 (Interim-intervention assessment)
Grip and pinch strength will be measured using a hand dynamometer. Grip strength is assessed by asking the participant to squeeze the dynamometer as hard as possible, while pinch strength measures the force exerted between the thumb and fingers. Results are recorded in kilograms or pounds of force. These measures provide an objective assessment of hand and forearm muscle strength, and will be used to track changes in upper limb strength over the course of the study.
Week 5 (Interim-intervention assessment)
Grip and pinch strength
Tidsramme: Week 8 (Post-intervention assessment)
Grip and pinch strength will be measured using a hand dynamometer. Grip strength is assessed by asking the participant to squeeze the dynamometer as hard as possible, while pinch strength measures the force exerted between the thumb and fingers. Results are recorded in kilograms or pounds of force. These measures provide an objective assessment of hand and forearm muscle strength, and will be used to track changes in upper limb strength over the course of the study.
Week 8 (Post-intervention assessment)
Grip and pinch strength
Tidsramme: Week12 (1 month after the intervention)
Grip and pinch strength will be measured using a hand dynamometer. Grip strength is assessed by asking the participant to squeeze the dynamometer as hard as possible, while pinch strength measures the force exerted between the thumb and fingers. Results are recorded in kilograms or pounds of force. These measures provide an objective assessment of hand and forearm muscle strength, and will be used to track changes in upper limb strength over the course of the study.
Week12 (1 month after the intervention)
Grip and pinch strength
Tidsramme: Week 20 (3 months after the intervention)
Grip and pinch strength will be measured using a hand dynamometer. Grip strength is assessed by asking the participant to squeeze the dynamometer as hard as possible, while pinch strength measures the force exerted between the thumb and fingers. Results are recorded in kilograms or pounds of force. These measures provide an objective assessment of hand and forearm muscle strength, and will be used to track changes in upper limb strength over the course of the study.
Week 20 (3 months after the intervention)
Modified Ashworth Scale (MAS)
Tidsramme: Week 0 (Pre-baseline assessment)
Modified Tardieu Scale is to measure if there is spasticity present in a person's muscle and its response to movement. It will be measured for upper limb muslces. A large difference between R1 and R2 suggests a large dynamic component with a greater capacity for change or improvement. A small difference between R1 and R2 suggests a predominantly fixed contracture in the muscle with a poorer capacity for change.
Week 0 (Pre-baseline assessment)
Modified Ashworth Scale (MAS)
Tidsramme: Week 2 (baseline assessment)
Modified Tardieu Scale is to measure if there is spasticity present in a person's muscle and its response to movement. It will be measured for upper limb muslces. A large difference between R1 and R2 suggests a large dynamic component with a greater capacity for change or improvement. A small difference between R1 and R2 suggests a predominantly fixed contracture in the muscle with a poorer capacity for change.
Week 2 (baseline assessment)
Modified Ashworth Scale (MAS)
Tidsramme: Week 5 (Interim-intervention assessment)
Modified Tardieu Scale is to measure if there is spasticity present in a person's muscle and its response to movement. It will be measured for upper limb muslces. A large difference between R1 and R2 suggests a large dynamic component with a greater capacity for change or improvement. A small difference between R1 and R2 suggests a predominantly fixed contracture in the muscle with a poorer capacity for change.
Week 5 (Interim-intervention assessment)
Modified Ashworth Scale (MAS)
Tidsramme: Week 8 (Post-intervention assessment)
Modified Tardieu Scale is to measure if there is spasticity present in a person's muscle and its response to movement. It will be measured for upper limb muslces. A large difference between R1 and R2 suggests a large dynamic component with a greater capacity for change or improvement. A small difference between R1 and R2 suggests a predominantly fixed contracture in the muscle with a poorer capacity for change.
Week 8 (Post-intervention assessment)
Motor Activity Log-14 (MAL-14)
Tidsramme: Week 12 (1 month after the intervention)
The Motor Activity Log-14 (MAL-14) consists of 14 items rated on two subscales - the Amount of Use (AOU) and Quality of Movement (QOM) scales. Each item is rated from 0 to 5, giving a total score range of 0 to 5 for each subscale, where higher scores indicate greater amount of use and better quality of movement of the affected arm in daily activities.
Week 12 (1 month after the intervention)
Motor Activity Log-14 (MAL-14)
Tidsramme: Week 20 (3 months after the intervention)
The Motor Activity Log-14 (MAL-14) consists of 14 items rated on two subscales - the Amount of Use (AOU) and Quality of Movement (QOM) scales. Each item is rated from 0 to 5, giving a total score range of 0 to 5 for each subscale, where higher scores indicate greater amount of use and better quality of movement of the affected arm in daily activities.
Week 20 (3 months after the intervention)
EQ5D
Tidsramme: Week 0 (Pre-baseline assessment)
EQ5D is an instrument which evaluates the generic quality of life developed in Europe and widely used. It has one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each dimension scored from 1 to 5, the higher score indicates worse performance.
Week 0 (Pre-baseline assessment)
EQ5D
Tidsramme: Week 2 (baseline assessment)
EQ5D is an instrument which evaluates the generic quality of life developed in Europe and widely used. It has one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each dimension scored from 1 to 5, the higher score indicates worse performance.
Week 2 (baseline assessment)
EQ5D
Tidsramme: Week 5 (Interim-intervention assessment)
EQ5D is an instrument which evaluates the generic quality of life developed in Europe and widely used. It has one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each dimension scored from 1 to 5, the higher score indicates worse performance.
Week 5 (Interim-intervention assessment)
EQ5D
Tidsramme: Week 8 (Post-intervention assessment)
EQ5D is an instrument which evaluates the generic quality of life developed in Europe and widely used. It has one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each dimension scored from 1 to 5, the higher score indicates worse performance.
Week 8 (Post-intervention assessment)
EQ5D
Tidsramme: Week12 (1 month after the intervention)
EQ5D is an instrument which evaluates the generic quality of life developed in Europe and widely used. It has one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each dimension scored from 1 to 5, the higher score indicates worse performance.
Week12 (1 month after the intervention)
EQ5D
Tidsramme: Week 20 (3 months after the intervention)
EQ5D is an instrument which evaluates the generic quality of life developed in Europe and widely used. It has one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each dimension scored from 1 to 5, the higher score indicates worse performance.
Week 20 (3 months after the intervention)
Corticospinal Excitability measurement by TMS- Motor threshold
Tidsramme: Week 0 (Pre-baseline assessment)
It is a non-invasive technique used to assess how readily the brain can activate the muscles. A magnetic coil is placed over the scalp above the motor area of the brain, and a brief magnetic pulse is delivered to stimulate the nerve pathways that connect the brain to the muscles (the corticospinal tract). The smallest pulse intensity needed to produce a visible or measurable muscle twitch is called the "motor threshold." A lower motor threshold means the brain-to-muscle pathway is more excitable or responsive, which is generally associated with better motor function.
Week 0 (Pre-baseline assessment)
Corticospinal Excitability measurement by TMS- Motor threshold
Tidsramme: Week 2 (baseline assessment)
It is a non-invasive technique used to assess how readily the brain can activate the muscles. A magnetic coil is placed over the scalp above the motor area of the brain, and a brief magnetic pulse is delivered to stimulate the nerve pathways that connect the brain to the muscles (the corticospinal tract). The smallest pulse intensity needed to produce a visible or measurable muscle twitch is called the "motor threshold." A lower motor threshold means the brain-to-muscle pathway is more excitable or responsive, which is generally associated with better motor function.
Week 2 (baseline assessment)
Corticospinal Excitability measurement by TMS- Motor threshold
Tidsramme: Week 5 (Interim-intervention assessment)
It is a non-invasive technique used to assess how readily the brain can activate the muscles. A magnetic coil is placed over the scalp above the motor area of the brain, and a brief magnetic pulse is delivered to stimulate the nerve pathways that connect the brain to the muscles (the corticospinal tract). The smallest pulse intensity needed to produce a visible or measurable muscle twitch is called the "motor threshold." A lower motor threshold means the brain-to-muscle pathway is more excitable or responsive, which is generally associated with better motor function.
Week 5 (Interim-intervention assessment)
Corticospinal Excitability measurement by TMS- Motor threshold
Tidsramme: Week 8 (Post-intervention assessment)
It is a non-invasive technique used to assess how readily the brain can activate the muscles. A magnetic coil is placed over the scalp above the motor area of the brain, and a brief magnetic pulse is delivered to stimulate the nerve pathways that connect the brain to the muscles (the corticospinal tract). The smallest pulse intensity needed to produce a visible or measurable muscle twitch is called the "motor threshold." A lower motor threshold means the brain-to-muscle pathway is more excitable or responsive, which is generally associated with better motor function.
Week 8 (Post-intervention assessment)
Corticospinal Excitability measurement by TMS- Motor threshold
Tidsramme: Week12 (1 month after the intervention)
It is a non-invasive technique used to assess how readily the brain can activate the muscles. A magnetic coil is placed over the scalp above the motor area of the brain, and a brief magnetic pulse is delivered to stimulate the nerve pathways that connect the brain to the muscles (the corticospinal tract). The smallest pulse intensity needed to produce a visible or measurable muscle twitch is called the "motor threshold." A lower motor threshold means the brain-to-muscle pathway is more excitable or responsive, which is generally associated with better motor function.
Week12 (1 month after the intervention)
Corticospinal Excitability measurement by TMS- Motor threshold
Tidsramme: Week 20 (3 months after the intervention)
It is a non-invasive technique used to assess how readily the brain can activate the muscles. A magnetic coil is placed over the scalp above the motor area of the brain, and a brief magnetic pulse is delivered to stimulate the nerve pathways that connect the brain to the muscles (the corticospinal tract). The smallest pulse intensity needed to produce a visible or measurable muscle twitch is called the "motor threshold." A lower motor threshold means the brain-to-muscle pathway is more excitable or responsive, which is generally associated with better motor function.
Week 20 (3 months after the intervention)
System Usability Scale (SUS)
Tidsramme: Week 8 (Post-intervention assessment)
SUS is a validated, 10-item questionnaire. Each item is rated on a 5-point Likert scale ranging from strongly disagree to strongly agree.
Week 8 (Post-intervention assessment)
MoCA
Tidsramme: Week 0 (Pre-baseline assessment)
It is a screening tool to detect mild cognitive impairment. It assesses several aspects of cognitive function, including memory, attention, language, and orientation. Scores range from 0 to 30, with a score of 26 or above generally considered normal. A lower score may indicate the presence of cognitive difficulties.
Week 0 (Pre-baseline assessment)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sponsor

Den organisation eller person, der igangsætter undersøgelsen, og som har myndighed og kontrol over undersøgelsen.
National University Hospital, Singapore

Samarbejdspartnere

Samarbejdspartnere

En anden organisation end sponsoren, der yder støtte til en klinisk undersøgelse. Denne støtte kan omfatte aktiviteter relateret til finansiering, design, implementering, dataanalyse eller rapportering.
Alexandra Hospital

Efterforskere

Efterforskere

En forsker involveret i et klinisk studie. Beslægtede termer omfatter stedets principal investigator, site sub-investigator, studieformand, undersøgelsesleder og undersøgelseshovedinvestigator.
  • Ledende efterforsker: Peijing Su, MBBS, NUH

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

Studiestart

Den faktiske dato, hvor den første deltager blev tilmeldt en klinisk undersøgelse. Den "forventede" undersøgelses startdato er den dato, som forskerne tror vil være undersøgelsens startdato.
1. oktober 2026

Primær færdiggørelse (Anslået)

Primær færdiggørelse

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention for at indsamle endelige data for det primære resultatmål. Hvorvidt det kliniske studie sluttede i henhold til protokollen eller blev afsluttet, påvirker ikke denne dato. For kliniske undersøgelser med mere end ét primært resultatmål med forskellige afslutningsdatoer refererer dette udtryk til den dato, hvor dataindsamlingen er afsluttet for alle de primære resultatmål. Den "forventede" primære afslutningsdato er den dato, som forskerne tror vil være den primære afslutningsdato for undersøgelsen.
30. september 2027

Studieafslutning (Anslået)

Studieafslutning

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention/behandling for at indsamle endelige data for de primære resultatmål, sekundære udfaldsmål og uønskede hændelser (det vil sige den sidste deltagers sidste besøg). Den "forventede" undersøgelses afslutningsdato er den dato, som forskerne tror vil være undersøgelsens afslutningsdato.
30. september 2027

Datoer for studieregistrering

Først indsendt

Først indsendt

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsendte en undersøgelsespost til ClinicalTrials.gov. Der er typisk en forsinkelse på et par dage mellem den første indsendte dato og postens tilgængelighed på ClinicalTrials.gov (den første offentliggjorte dato).
20. august 2026

Først indsendt, der opfyldte QC-kriterier

Først indsendt, der opfyldte QC-kriterier

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsender en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Sponsoren eller investigatoren skal muligvis revidere og indsende en undersøgelsespost en eller flere gange, før NLM's kvalitetskontrolkriterier er opfyldt. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
20. august 2026

Først opslået (Faktiske)

Først opslået

Datoen, hvor undersøgelsesposten først var tilgængelig på ClinicalTrials.gov efter National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgang er afsluttet. Der er typisk en forsinkelse på et par dage mellem den dato, hvor undersøgelsens sponsor eller investigator indsendte undersøgelsesposten, og den første offentliggjorte dato.
25. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering sendt

Den seneste dato, hvor ændringer i en undersøgelsespost blev gjort tilgængelig på ClinicalTrials.gov. Der kan være en forsinkelse mellem det tidspunkt, hvornår ændringerne blev indsendt til ClinicalTrials.gov af undersøgelsens sponsor eller investigator (datoen for sidste opdatering afsendt) og den sidste opdatering, der blev sendt.
25. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Den seneste dato, hvor undersøgelsens sponsor eller investigator indsendte ændringer til en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
20. august 2026

Sidst verificeret

Sidst verificeret

Den seneste dato, hvor undersøgelsens sponsor eller investigator bekræftede oplysningerne om en klinisk undersøgelse på ClinicalTrials.gov som nøjagtige og aktuelle. Hvis en undersøgelse med rekrutteringsstatus som rekruttering; rekrutterer endnu ikke; eller aktiv, ikke rekruttering er ikke blevet bekræftet inden for de seneste 2 år, er undersøgelsens rekrutteringsstatus vist som ukendt.
1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Andre undersøgelses-id-numre

Andre identifikatorer eller ID-numre end NCT-nummeret, der er tildelt til en klinisk undersøgelse af undersøgelsens sponsor, finansieringsgivere eller andre. Disse numre kan omfatte unikke identifikatorer fra andre forsøgsregistre og National Institutes of Health-bevillingsnumre.
  • 2026-0446

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Cookieindstillinger

Vi bruger cookies for at sikre, at vi giver dig den bedste oplevelse på vores hjemmeside. For flere detaljer skal du læse omhyggeligt vores Politik om beskyttelse af personlige oplysninger og cookies. ...>>>Du kan når som helst ændre dine præferencer eller trække dit samtykke tilbage ved at slette cookies fra din hjemmeside eller computer som beskrevet i politikken. Accepter det og vælg dine præferencer ved at markere de tilsvarende felter i afsnittet "Administrer indstillinger" nedenfor. Læs vores servicevilkår omhyggeligt, inden du fortsætter med at bruge nogen del af dette websted.
«Administrer indstillinger