Stroke Rehabilitation Using Extended Reality. (STRIVE)
Stroke Rehabilitation With Innovative Extended Reality (STRIVE): A Feasibility Study in Clinical Practice
After a stroke, many people experience difficulties with movement, balance, or everyday activities. Rehabilitation is an important part of recovery and can help people regain function and confidence in daily life. However, rehabilitation can sometimes become repetitive, tiring, or difficult to maintain over time.
This research project studies the use of Mixed Reality (MR) in stroke rehabilitation. MR uses special glasses that project digital holograms into the real-world environment. This allows individuals to see and interact with virtual objects while remaining aware of and moving within their actual surroundings. Using MR, people can practice movements and functional activities in a safe, engaging, and interactive way. The holographic exercises can be repeated many times in a structured manner, which is important for recovery after stroke. At the same time, the training can be varied to reduce monotony and maintain motivation.
The exercises can be individually adapted to each person's abilities, rehabilitation goals, and daily condition. The level of difficulty can be adjusted as the person progresses. MR systems can also provide immediate visual and auditory feedback, helping individuals understand their performance and encouraging active participation in their rehabilitation.
The project also focuses on how patients experience this type of training and how it fits into everyday life.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Stroke is a leading cause of long-term disability worldwide. Many individuals living with chronic stroke experience persistent impairments in motor function, balance, gait, activities of daily living (ADL), and health-related quality of life. Effective rehabilitation requires intensive, task-specific, and repetitive practice; however, maintaining motivation and adherence to conventional rehabilitation programs can be challenging.
Extended Reality (XR) technologies have emerged as promising tools in rehabilitation. XR-based training can provide structured, repetitive, and individualized exercises while incorporating interactive holographic elements into the rehabilitation process. The exercises can be adapted to each participant's abilities and rehabilitation goals, and the level of difficulty can be adjusted according to individual performance and progression.
The Stroke Rehabilitation with Innovative Extended Reality (STRIVE) program was developed to provide a structured XR-based rehabilitation intervention for individuals with chronic stroke. The intervention utilizes the RehAtt XR system and includes exercises targeting upper extremity function, lower extremity function, balance, gait performance, and functional activities.
The primary aim of this study is to investigate whether XR-based rehabilitation, based on established virtual reality rehabilitation principles, can influence motor function, balance, gait performance, activities of daily living, and health-related quality of life in individuals living with chronic stroke. A secondary aim is to explore participants' experiences of using and training with XR technology and to evaluate the feasibility of implementing the intervention in routine clinical practice.
The study uses a Single-Case Experimental Design (SCED) in which each participant serves as their own control. During the baseline phase, repeated assessments will be conducted without XR training to establish the stability of outcome measures and capture natural variation in performance. The baseline phase will last between 1 and 3 weeks and include a minimum of 5 and a maximum of 9 assessment points. Following baseline, participants will receive XR-based rehabilitation for 5 weeks. Outcome measures will continue to be collected three times per week throughout the intervention phase, with assessments performed prior to each XR training session to explore potential changes in physical function, activity performance, participation, and quality of life. The findings will provide important information regarding the feasibility and potential benefits of XR-based stroke rehabilitation and will inform the design of future larger-scale studies.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Ingela Marklund, Senior Physiotherapist, PhD.
- Número de teléfono: +4610-8314216
- Correo electrónico: ingela.marklund@regionvarmland.se
Copia de seguridad de contactos de estudio
- Nombre: Dana Islam, physiotherapist, PhD student
- Número de teléfono: +4610-8315777
- Correo electrónico: dana.islam@regionvarmland.se
Ubicaciones de estudio
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Värmland County
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Torsby, Värmland County, Suecia
- Rehabilitation Unit, Torsby Hospital
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Contacto:
- Emma Östlund, fysioterapeut
- Número de teléfono: +4610-8347460
- Correo electrónico: emma.ostlund@regionvarmland.se
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
Adults (≥ 18 years) with a verified stroke diagnosis at least six months ago
- Sufficient cognitive ability MMES (mini mental state examination) ≥ 23
- Continued need for rehabilitation
- Ability to walk at least 10 meters, with or without aids
- Be able to read, understand and express themselves in the Swedish language.
Exclusion Criteria:
• Serious vision problems that would affect the use of XR equipment
- Other progressive or serious illness such as multiple sclerosis, Parkinson's disease, dementia or cancer
- People with epilepsy or pacemakers
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: XR-Based Stroke Rehabilitation
Participants will receive XR-based rehabilitation using the RehAtt XR system.
The intervention consists of individualized exercises targeting upper extremity function, lower extremity function, balance, gait, and functional activities.
Training will be delivered three times per week for five weeks following a baseline phase with repeated assessments.
Exercise difficulty will be adjusted according to each participant's abilities, performance, and rehabilitation goals.
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Participants will receive XR-based rehabilitation using the RehAtt XR system.
The intervention consists of individualized exercises targeting upper extremity function, lower extremity function, balance, gait, and functional activities.
Training will be delivered three times per week for five weeks following a baseline phase with repeated assessments.
Exercise difficulty will be adjusted according to each participant's abilities, performance, and rehabilitation goals.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Fugl-Meyer Assessment Lower Extremity (FMA-LE)
Periodo de tiempo: Baseline(5,7,9 assessments over 1.5-3 weeks before the intervention,randomly assigned to each participant). 3 times per week during the 5-week intervention(assessments conducted before XR training). At 3 and 6 months after completion of the intervention.
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Assessment of lower extremity motor function following stroke.
Scores range from 0 to 34, with higher scores indicating better motor function.
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Baseline(5,7,9 assessments over 1.5-3 weeks before the intervention,randomly assigned to each participant). 3 times per week during the 5-week intervention(assessments conducted before XR training). At 3 and 6 months after completion of the intervention.
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Action Research Arm Test (ARAT)
Periodo de tiempo: Baseline(5,7,9 assessments over 1.5-3 weeks before the intervention,randomly assigned to each participant). 3 times per week during the 5-week intervention(assessments conducted before XR training). At 3 and 6 months after completion of the intervention.
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Assessment of upper extremity activity capacity and manual dexterity.
Higher scores indicate better upper limb function.
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Baseline(5,7,9 assessments over 1.5-3 weeks before the intervention,randomly assigned to each participant). 3 times per week during the 5-week intervention(assessments conducted before XR training). At 3 and 6 months after completion of the intervention.
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Timed Up and Go Test (TUG)
Periodo de tiempo: Baseline(5,7,9 assessments over 1.5-3 weeks before the intervention,randomly assigned to each participant). 3 times per week during the 5-week intervention(assessments conducted before XR training). At 3 and 6 months after completion of the intervention.
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Assessment of functional mobility.
Time required to stand up from a chair, walk 3 meters, turn, return, and sit down.
Shorter times indicate better mobility.
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Baseline(5,7,9 assessments over 1.5-3 weeks before the intervention,randomly assigned to each participant). 3 times per week during the 5-week intervention(assessments conducted before XR training). At 3 and 6 months after completion of the intervention.
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10-Meter Walk Test (10MWT)
Periodo de tiempo: Baseline(5,7,9 assessments over 1.5-3 weeks before the intervention,randomly assigned to each participant). 3 times per week during the 5-week intervention(assessments conducted before XR training). At 3 and 6 months after completion of the intervention.
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Assessment of walking speed over a 10-meter distance.
Higher walking speed indicates better gait performance.
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Baseline(5,7,9 assessments over 1.5-3 weeks before the intervention,randomly assigned to each participant). 3 times per week during the 5-week intervention(assessments conducted before XR training). At 3 and 6 months after completion of the intervention.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Barthel Index
Periodo de tiempo: Assessed at four time points: the initial baseline assessment, immediately post-intervention, and at 3 and 6 months following completion of the intervention.
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Assessment of independence in activities of daily living.
Higher scores indicate greater independence.
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Assessed at four time points: the initial baseline assessment, immediately post-intervention, and at 3 and 6 months following completion of the intervention.
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RAND-36
Periodo de tiempo: Assessed at four time points: the initial baseline assessment, immediately post-intervention, and at 3 and 6 months following completion of the intervention.
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Assessment of health-related quality of life across multiple domains.
Higher scores indicate better perceived health status.
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Assessed at four time points: the initial baseline assessment, immediately post-intervention, and at 3 and 6 months following completion of the intervention.
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Participants' Experiences of XR-Based Rehabilitation
Periodo de tiempo: End of intervention, 3-month follow-up, and 6-month follow-up.
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Semi-structured individual interviews will be conducted to explore participants' experiences of XR-based rehabilitation and changes over time.
The interview guide will explore experiences of XR-based rehabilitation, including perceived benefits, challenges, motivation, fatigue, and the impact of the intervention on everyday life.
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End of intervention, 3-month follow-up, and 6-month follow-up.
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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Enviado por primera vez
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Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CIV-ID 26-04-057614
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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