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Effects of Combined Robot-assisted Therapy With Mirror Priming in Stroke Patients

11. februar 2022 opdateret af: Chang Gung Memorial Hospital

Effects of Combined Robot-assisted Therapy With Mirror Priming on Hand Function and Health-related Conditions in Patients With Stroke.

The purpose of this study is to examine the effects of combining robotic-assisted training and mirror therapy on upper extremity motor and physiological function, daily functions, quality of life and self-efficacy in stroke patients.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Based on trigger theory, this study designed a combining robotic-assisted training and mirror therapy. Before robotic-assisted training, a mirror therapy is performed to double the healing effect of robotic-assisted training.

This study hypothesized that combining robotic-assisted training and mirror therapy can improve the performance of hand function in stroke patients and promote daily life function, quality of life, and self-efficacy compared to single machine-assisted therapy.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

43

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Taiwan
      • Taoyuan City, Taiwan, 333
        • Chang Gung Memorial Hospital

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

Aldre berettiget til at studere

20 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Brain injury more than 3 months.
  2. Modified Ashworth Scale proximal part ≤ 3, Modified Ashworth Scale distal part ≤ 2, and no serious muscle spasms.
  3. The myoelectric signal can be detected to activate the instrument
  4. unilateral paresis (FMA score<60)
  5. no serious cognitive impairment (i.e., Mini Mental State Exam score > 24)
  6. can provide informed consent

Exclusion Criteria:

  1. Other neurological disease
  2. Complete sense of body defect
  3. Inability to understand instructions
  4. current participation in any other research
  5. Botulinum Toxin injection within 3 months

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: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Robotic training with mirror therapy
20 minutes mirror therapy followed by 40 minutes robotic-assisted training
Adfærdsmæssigt: Robotic training with mirror therapy
Participants will receive 18 intervention sessions for about 6 consecutive weeks in a clinical setting (1 hour per session, 3 sessions per week). For each intervention session, participants will first receive 20 minutes mirror therapy followed by 40 minutes robotic-assisted training (robotic-assisted training includes 10 minutes active/passive training mode and 30 minutes robot-participant interactive training mode).
Sham-komparator: Robotic-assisted training
20 minutes sham mirror therapy followed by 40 minutes robotic-assisted training
Adfærdsmæssigt: Robotic-assisted training
The training procedure will be the same as the robotic-assisted training with mirror therapy group except that sham mirror therapy will be provided in the first 20 minutes in the intervention session.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Skift score for Active Range of Motion (AROM)
Tidsramme: Baseline, post-test umiddelbart efter at have gennemført 18 interventionssessioner (ca. 6 uger efter baseline), opfølgningstest (3 måneder efter at have afsluttet interventionssessioner)
Patienten udfører øvelsen for at bevæge leddet uden hjælp til musklerne omkring leddet.
Baseline, post-test umiddelbart efter at have gennemført 18 interventionssessioner (ca. 6 uger efter baseline), opfølgningstest (3 måneder efter at have afsluttet interventionssessioner)
Skift score for Modified Ashworth Scale (MAS)
Tidsramme: Baseline, post-test umiddelbart efter at have gennemført 18 interventionssessioner (ca. 6 uger efter baseline), opfølgningstest (3 måneder efter at have afsluttet interventionssessioner)
MAS er en 6-punkts ordinal skala, der måler muskelspasticitet hos patienter med hjernelæsioner. Højere score indikerer højere muskeltonus. Efterforskere vil vurdere MAS-scorerne for UE-muskler, herunder biceps, triceps, håndledsbøjere og -ekstensorer, og fingerfleksorer og -ekstensorer. Validiteten og reliabiliteten af ​​MAS for patienter med slagtilfælde blev fastslået til at være tilstrækkelig til god.
Baseline, post-test umiddelbart efter at have gennemført 18 interventionssessioner (ca. 6 uger efter baseline), opfølgningstest (3 måneder efter at have afsluttet interventionssessioner)
Ændre score på Medical Research Council-skalaen (MRC)
Tidsramme: Baseline, post-test umiddelbart efter at have gennemført 18 interventionssessioner (ca. 6 uger efter baseline), opfølgningstest (3 måneder efter at have afsluttet interventionssessioner)
MRC er en ordinalskala, der vurderer muskelstyrke. Scoringen for hver muskel varierer fra 0 til 5, med en højere score indikerer stærkere muskel. Pålideligheden af ​​MRC for alle muskelgrupper var god til fremragende hos patienter med slagtilfælde.
Baseline, post-test umiddelbart efter at have gennemført 18 interventionssessioner (ca. 6 uger efter baseline), opfølgningstest (3 måneder efter at have afsluttet interventionssessioner)
Skift score for Mini-Mental State Exam (MMSE)
Tidsramme: Baseline, post-test umiddelbart efter at have gennemført 18 interventionssessioner (ca. 6 uger efter baseline), opfølgningstest (3 måneder efter at have afsluttet interventionssessioner)
Mini-Mental State Examination (MMSE) er den mest almindeligt administrerede psykometriske screeningsvurdering af kognitiv funktion. MMSE bruges til at screene patienter for kognitiv svækkelse, spore ændringer i kognitiv funktion over tid og ofte til at vurdere virkningerne af terapeutiske midler på kognitiv funktion. Den samlede score for MMSE varierede fra 0 til 30. Højere værdier repræsenterer en bedre kognitiv funktion.
Baseline, post-test umiddelbart efter at have gennemført 18 interventionssessioner (ca. 6 uger efter baseline), opfølgningstest (3 måneder efter at have afsluttet interventionssessioner)
Ændring af score for slagtilfælde-selveffektivitetsspørgeskema (SSEQ)
Tidsramme: Baseline, post-test umiddelbart efter at have gennemført 18 interventionssessioner (ca. 6 uger efter baseline), opfølgningstest (3 måneder efter at have afsluttet interventionssessioner)
Stroke Self-Efficacy Questionnaire (SSEQ), et spørgeskema udviklet til at måle de mest relevante self-efficacy og self-management domæner, der er specifikke for slagtilfældepopulationen. Den indeholder 13 genstande, der er bedømt på en 0 - 10 skala, med højere score, der indikerer større niveauer af selveffektivitet. Spørgeskemaet omfatter en række relevante funktionelle opgaver såsom at gå, at blive komfortabel i sengen samt nogle selvledelsesopgaver.
Baseline, post-test umiddelbart efter at have gennemført 18 interventionssessioner (ca. 6 uger efter baseline), opfølgningstest (3 måneder efter at have afsluttet interventionssessioner)
Skift score for Daily Living Self-Efficacy Scale (DLSE)
Tidsramme: Baseline, post-test umiddelbart efter at have gennemført 18 interventionssessioner (ca. 6 uger efter baseline), opfølgningstest (3 måneder efter at have afsluttet interventionssessioner)
DLSES er designet til at måle selveffektivitet i psykosocial funktion og self-efficacy i daglige aktiviteter, uanset niveauet af fysisk funktionsnedsættelse.
Baseline, post-test umiddelbart efter at have gennemført 18 interventionssessioner (ca. 6 uger efter baseline), opfølgningstest (3 måneder efter at have afsluttet interventionssessioner)
Skift score for funktionelle evner konfidensskala (FACS)
Tidsramme: Baseline, post-test umiddelbart efter at have gennemført 18 interventionssessioner (ca. 6 uger efter baseline), opfølgningstest (3 måneder efter at have afsluttet interventionssessioner)
Functional Abilities Confidence Scale (FACS) blev designet til at måle graden af ​​selveffektivitet eller selvtillid en patient udviser med forskellige bevægelser eller stillinger.
Baseline, post-test umiddelbart efter at have gennemført 18 interventionssessioner (ca. 6 uger efter baseline), opfølgningstest (3 måneder efter at have afsluttet interventionssessioner)
Change scores of Fugl-Myer Assessment (FMA)
Tidsramme: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
The UE-FMA subscale will be used to assess the sensorimotor impairment level of UE in patients after stroke. The UE-FMA contains 33 movements with a score range from 0 to 66. A higher UE-FMA score indicates less impairment of the paretic limb. The validity and reliability of FMA is good to excellent.
Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
Change scores of grip and pinch power(Jamar hand dynamometer)
Tidsramme: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
The Jamar hand dynamometer is the most widely cited in the literature and accepted as the gold standard by which other dynamometers are evaluated. Excellent concurrent validity of the Jamar hand dynamometer is reported. The Jamar hand dynamometer measure the grip-strength. The norm of healthy male aged 18 to 75 years is from 64.8 lb to 121.8 lb, while the norm of healthy female aged 18 to 75 years is from 41.5 lb to 78.7 lb. Higher value represent a greater grip-strength.
Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
Change scores of MyotonPro
Tidsramme: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
Investigators will use the MyotonPRO device to evaluate the viscoelastic properties of UE muscles.
Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
Change scores of pressure pain threshold
Tidsramme: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
The Commander Algometer (JTECH Medical, USA) is designed for easy handling and fine resolution to identify clinically significant pain sensitivity changes. The Commander Algometer provides a convenient, efficient, objective pain evaluation tool for treatment planning, progress evaluation and case management. The measured pressure thresholds/tolerances and trigger point tenderness will be reported by patients.
Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
Change scores of Revised Nottingham Sensory Assessment (RNSA)
Tidsramme: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
Changes in sensation before and after intervention will be measured with rNSA. Tactile sensation,proprioception, and stereognosis will be assessed with various sensory modalities. The rNSA is scored based on a 3-point ordinal scale (0-2) with a higher score indicates better sensation. The psychometric properties of rNSA have been established in patients with stroke.
Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
Change scores of Wolf Motor Function Test (WMFT)
Tidsramme: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
The Wolf Motor Function Test evaluates upper extremity motor function via 15 function-based tasks and 2 strength-based tasks. The Wolf Motor Function Test -time evaluates the time required to complete the function-based tasks, and the Wolf Motor Function Test -quality assesses functional ability on a 6-point ordinal scale. A lower Wolf Motor Function Test -time performance indicates faster movement, whereas a higher Wolf Motor Function Test -quality score suggests better quality of movement. The psychometric properties of Wolf Motor Function Test have been established in stroke patients.
Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
Change scores of Jamar hand dynamometer
Tidsramme: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
The Jamar hand dynamometer is the most widely cited in the literature and accepted as the gold standard by which other dynamometers are evaluated. Excellent concurrent validity of the Jamar hand dynamometer is reported. The Jamar hand dynamometer measure the grip-strength. The norm of healthy male aged 18 to 75 years is from 64.8 lb to 121.8 lb, while the norm of healthy female aged 18 to 75 years is from 41.5 lb to 78.7 lb. Higher value represent a greater grip-strength.
Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
Change scores of Motor Activity Log (MAL)
Tidsramme: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
The Motor Activity Log evaluates the amount of use (AOU) and quality of movement (QOM) of the affected hand in completing 30 common daily tasks. Scoring of each task ranges from 0 to 5, with higher scores indicating more use or better movement quality. The responsiveness, validity, and reliability have been established in stroke patients.
Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
Change scores of Nottingham Extended Activities of Daily Living Scale (NEADL)
Tidsramme: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
The NEADL is a self-report scale that measures instrumental activities of daily living. It evaluates 4 areas of daily living, including mobility, kitchen, domestic, and leisure activities. The total score is 0-66, and a higher score indicates better daily functional ability. The psychometric properties of NEADL have been well established.
Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
Change scores of Stroke Impact Scale (SIS)
Tidsramme: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
The SIS 3.0 will be used to evaluate health-related quality of life for patients with stroke. The SIS assesses eight domains (strength, hand function, ADL/IADL, mobility, communication, emotion, memory and thinking, and participation/role function) with 59 test items.
Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Kinematic Analysis
Tidsramme: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline)
The movements of the arm and trunk will be captured by a 7-camera motion analysis system during unilateral and bilateral reaching tasks. Kinematic variables, such as reaction time, movement time, peak velocity, path length during the tasks can assess a patient's motor function in daily activities after intervention.
Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline)

Samarbejdspartnere og efterforskere

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

Sponsor

Chang Gung Memorial Hospital

Efterforskere

  • Ledende efterforsker: Ching-yi Wu, ScD, Chang Gung University

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 (Faktiske)

17. december 2018

Primær færdiggørelse (Faktiske)

20. april 2021

Studieafslutning (Faktiske)

20. april 2021

Datoer for studieregistrering

Først indsendt

8. januar 2019

Først indsendt, der opfyldte QC-kriterier

15. april 2019

Først opslået (Faktiske)

17. april 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. marts 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. februar 2022

Sidst verificeret

1. juni 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 201801025B0

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