Stroke Rehabilitation Using Extended Reality. (STRIVE)

September 3, 2026 updated by: Värmland County Council, Sweden

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Sweden
    • Värmland County
      • Torsby, Värmland County, Sweden

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Device: RehAtt XR System
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fugl-Meyer Assessment Lower Extremity (FMA-LE)
Time Frame: 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.
Assessment of lower extremity motor function following stroke. Scores range from 0 to 34, with higher scores indicating better motor function.
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.
Action Research Arm Test (ARAT)
Time Frame: 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.
Assessment of upper extremity activity capacity and manual dexterity. Higher scores indicate better upper limb function.
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.
Timed Up and Go Test (TUG)
Time Frame: 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.
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.
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.
10-Meter Walk Test (10MWT)
Time Frame: 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.
Assessment of walking speed over a 10-meter distance. Higher walking speed indicates better gait performance.
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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Barthel Index
Time Frame: Assessed at four time points: the initial baseline assessment, immediately post-intervention, and at 3 and 6 months following completion of the intervention.
Assessment of independence in activities of daily living. Higher scores indicate greater independence.
Assessed at four time points: the initial baseline assessment, immediately post-intervention, and at 3 and 6 months following completion of the intervention.
RAND-36
Time Frame: Assessed at four time points: the initial baseline assessment, immediately post-intervention, and at 3 and 6 months following completion of the intervention.
Assessment of health-related quality of life across multiple domains. Higher scores indicate better perceived health status.
Assessed at four time points: the initial baseline assessment, immediately post-intervention, and at 3 and 6 months following completion of the intervention.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participants' Experiences of XR-Based Rehabilitation
Time Frame: End of intervention, 3-month follow-up, and 6-month follow-up.
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.
End of intervention, 3-month follow-up, and 6-month follow-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Värmland County Council, Sweden

Collaborators

Örebro University, Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2027

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2028

Study Registration Dates

First Submitted

August 31, 2026

First Submitted That Met QC Criteria

September 3, 2026

First Posted (Actual)

September 10, 2026

Study Record Updates

Last Update Posted (Actual)

September 10, 2026

Last Update Submitted That Met QC Criteria

September 3, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIV-ID 26-04-057614

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared due to ethical and privacy considerations and the small sample size of this study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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