- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07811440
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.
Studieoversikt
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Ingela Marklund, Senior Physiotherapist, PhD.
- Telefonnummer: +4610-8314216
- E-post: ingela.marklund@regionvarmland.se
Studer Kontakt Backup
- Navn: Dana Islam, physiotherapist, PhD student
- Telefonnummer: +4610-8315777
- E-post: dana.islam@regionvarmland.se
Studiesteder
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Värmland County
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Torsby, Värmland County, Sverige
- Rehabilitation Unit, Torsby Hospital
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Ta kontakt med:
- Emma Östlund, fysioterapeut
- Telefonnummer: +4610-8347460
- E-post: emma.ostlund@regionvarmland.se
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Fugl-Meyer Assessment Lower Extremity (FMA-LE)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Barthel Index
Tidsramme: 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
Tidsramme: 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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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Participants' Experiences of XR-Based Rehabilitation
Tidsramme: 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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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Studierekorddatoer
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Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CIV-ID 26-04-057614
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