Effects of Ecologically Valid VR Task-Oriented Exercises on Post-Stroke Motor and Cognitive Function (RECOVER)
Effectiveness of Virtual Reality-based Task-oriented Exercises in Ecologically Valid Environments on Motor and Cognitive Function in Individuals Post-stroke. A Randomized Controlled Trial
Why is this study being done?
After a stroke, many people have problems with movement, such as walking, balance, and using their arms and hands. They may also experience difficulties with thinking skills, including attention, memory, and problem-solving. These movement and thinking abilities work closely together during everyday activities, such as preparing a meal, shopping, or moving safely through the home.
Traditional rehabilitation often treats movement and thinking problems separately. However, difficulties with attention, planning, and decision-making can affect a person's ability to move safely and learn new motor skills. Because of this, rehabilitation approaches that train both movement and thinking skills at the same time may provide greater benefits.
Virtual reality (VR) technology can create realistic, interactive environments that allow people to practice everyday activities in a safe setting. However, there is limited research on VR programs that simultaneously challenge both movement and thinking skills, and little is known about whether any benefits last over time.
What is the purpose of this study?
The purpose of this study is to compare a virtual reality-based rehabilitation program that combines movement and cognitive training in realistic everyday environments with conventional occupational therapy. The study will evaluate whether the VR program leads to greater improvements in motor function and cognitive function after stroke and whether these improvements are maintained over the long term.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
-
Valencia, Spanien
- IRENEA. Instituto de Rehabilitación Neurológica
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
Inclusion Criteria:
- Diagnosis of stroke confirmed by computed tomography or magnetic resonance imaging
- Chronicity > six months
- Ausence of severe cognitive deficits (Mini-Mental State Examination > 23)
- Ability to stand safely and without assistance
- No or minimal muscle tone (Modified Ashworth Scale < 3).
Exclusion Criteria:
- Severe visual or hearing deficits
- Unilateral spatial neglect
- Ataxia
- Orthopedic abnormalities
- Lower limb pain syndrome or peripheral nerve injury affecting the lower limbs.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Control
Conventional occupational therapy
|
Each session consists of three components.
The first component includes preparatory activities designed to improve function of the affected upper limb.
The second component focuses on fine motor skill training through exercises targeting reaching, grasping, object manipulation, and movements across the body's midline.
The third component addresses individual motor and cognitive impairments through the practice of Basic Activities of Daily Living and Instrumental Activities of Daily Living, as well as structured problem-solving tasks related to everyday situations.
|
|
Experimentell: Experimental
Combined virtual reality-based exercises and conventional occupational therapy
|
Each session consists of three components.
The first component includes preparatory activities designed to improve function of the affected upper limb.
The second component focuses on fine motor skill training through exercises targeting reaching, grasping, object manipulation, and movements across the body's midline.
The third component addresses individual motor and cognitive impairments through the practice of Basic Activities of Daily Living and Instrumental Activities of Daily Living, as well as structured problem-solving tasks related to everyday situations.
The intervention consists of interactive video games to train activities of daily living in a customizable digital version of the participant's own kitchen. During training, participants control a sex-matched avatar that reflects their real-time movements. They interact with common kitchen objects while practicing tasks that target both motor abilities, such as balance, posture, and hand-eye coordination, and cognitive abilities, such as attention, memory, planning, and problem-solving. The system can use photographs of the participant's home kitchen to create a familiar and realistic virtual environment. This approach is intended to support the transfer of skills practiced during therapy to the participant's everyday activities at home. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Berg Balance Scale
Tidsram: From baseline to the end of the intervention and from the end of the intervention to one-month after the intervention
|
Change in the balance of the Berg Balance Scale from baseline to the end of the intervention and from the end of the intervention to follow-up. The Berg Balance Scale is a clinical tool that assesses a person's static and dynamic balance to determine their risk of falling. It is primarily used for older adults and patients with neurological or motor disorders. Score range 0-54 |
From baseline to the end of the intervention and from the end of the intervention to one-month after the intervention
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Functional Reaches Test
Tidsram: From baseline to the end of the intervention and from the end of the intervention to one-month after the intervention
|
Change in the Functional Reaches Test from baseline to the end of the intervention and from the end of the intervention to follow-up. The Functional Reach Test measures a person's dynamic balance and stability limits while standing. It specifically assesses the maximum distance a patient can reach forward with an outstretched arm without taking a step or losing balance. Score range: NA |
From baseline to the end of the intervention and from the end of the intervention to one-month after the intervention
|
|
Change in Four Square Step Test
Tidsram: From baseline to the end of the intervention and from the end of the intervention to one-month after the intervention
|
Change in the seconds of the Four Square Step Test from baseline to the end of the intervention and from the end of the intervention to follow-up.
The Four Square Step Test (FSST) is a performance-based assessment that evaluates dynamic balance, mobility, and the ability to change direction while walking.
During the test, participants step as quickly as possible in a specific sequence through four squares formed by low obstacles on the floor, moving forward, backward, and sideways.
The test measures the time required to complete the sequence and assesses balance control, coordination, agility, and the ability to safely negotiate obstacles during movement.
It is commonly used to identify mobility limitations and fall risk in individuals with neurological conditions, including stroke.
Score range: NA
|
From baseline to the end of the intervention and from the end of the intervention to one-month after the intervention
|
|
Change in the 10-meters walk Test
Tidsram: From baseline to the end of the intervention and from the end of the intervention to one-month after the intervention
|
Change in the 10-meters walk Test from baseline to the end of the intervention and from the end of the intervention to follow-up.
The 10-Meter Walk Test measures walking speed in meters per second (m/s).
It assesses functional mobility, independence, and frailty by recording the time it takes a patient to walk a short distance (typically the central 6- or 8-meter section of a 10- to 14-meter corridor).
Score range: NA
|
From baseline to the end of the intervention and from the end of the intervention to one-month after the intervention
|
|
Change in the Activities-Specific Balance Confidence Scale
Tidsram: From baseline to the end of the intervention and from the end of the intervention to one-month after the intervention
|
Change in the Activities-Specific Balance Confidence Scale from baseline to the end of the intervention and from the end of the intervention to follow-up.
The Activities-Specific Balance Confidence Scale is a questionnaire that assesses a person's confidence in maintaining balance and avoiding falls while performing 16 everyday activities.
Score range: 0-100.
|
From baseline to the end of the intervention and from the end of the intervention to one-month after the intervention
|
|
Change in the Conner's Continuous Performance Test III
Tidsram: From baseline to the end of the intervention and from the end of the intervention to one-month after the intervention
|
Change in the Conner's Continuous Performance Test III from baseline to the end of the intervention and from the end of the intervention to follow-up.
The Conners Continuous Performance Test is a computerized neuropsychological test that assesses sustained attention, vigilance, inhibitory control (impulsivity), and selective attention.
Score range: NA
|
From baseline to the end of the intervention and from the end of the intervention to one-month after the intervention
|
|
Changes in the Spatial Span Test
Tidsram: From baseline to the end of the intervention and from the end of the intervention to one-month after the intervention
|
Changes in the Spatial Span Test from baseline to the end of the intervention and from the end of the intervention to follow-up.
The Spatial Span Test measures visuospatial short-term memory and visual working memory capacity.
Score ranges: 0-9
|
From baseline to the end of the intervention and from the end of the intervention to one-month after the intervention
|
|
Changes in the Trail Making Test
Tidsram: From baseline to the end of the intervention and from the end of the intervention to one-month after the intervention
|
Changes in the seconds of part A and part B for Trail Making Test from baseline to the end of the intervention and from the end of the intervention to follow-up.
The Trail Making Test is designed to assess attention, processing speed, cognitive flexibility, and executive functions.
It consists of two parts (A and B) in which the patient must connect numbered or lettered circles as quickly as posible.
Score Range: 0-300 s
|
From baseline to the end of the intervention and from the end of the intervention to one-month after the intervention
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Roberto Llorens, PhD, Universitat Politecnica de Valencia
Publikationer och användbara länkar
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- P0524032022
- PID2022-141498OA-I00 (Annat bidrag/finansieringsnummer: Ministerio de Ciencia e Innovación)
- RTC2019-006933-7 (Annat bidrag/finansieringsnummer: Ministerio de Ciencia e Innovación)
- INREIA/2024/73 (Annat bidrag/finansieringsnummer: Conselleria d'Innovació, Indústria, Comerç i Turisme)
- CIDEXG/2022/15 (Annat bidrag/finansieringsnummer: Conselleria d'Innovació, Universitats, Ciència i Societat Digital of Generalitat Valenciana)
- 60/2023 (Annat bidrag/finansieringsnummer: Fundació la Marató de la TV3)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .