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NCT Number: NCT07811440

Stroke Rehabilitation Using Extended Reality.

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rehabilitation Unit, Torsby Hospital

Torsby, Värmland County, Sweden

Location contact

Emma Östlund, fysioterapeut

CONTACT

[email protected]

+4610-8347460

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RehAtt XR System

Device

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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.

  2. 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.

Other outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dana Islam, physiotherapist, PhD student

CONTACT

[email protected]

+4610-8315777

Ingela Marklund, Senior Physiotherapist, PhD.

CONTACT

[email protected]

+4610-8314216

Sponsors and collaborators

Lead sponsor

Värmland County Council, Sweden

Other Gov

Collaborators

  • Örebro University, Sweden

Registry information

Official study title

Stroke Rehabilitation With Innovative Extended Reality (STRIVE): A Feasibility Study in Clinical Practice

Acronym: STRIVE

Important dates

Study start
2027
Primary completion
2027
Study completion
2028
First posted
Sep 10, 2026
Registry last updated
Sep 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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