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Stroke Rehabilitation Using Extended Reality.

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07811440
Acronym
STRIVE
Enrollment
9
Registered
2026-09-10
Start date
2027-09-01
Completion date
2028-09-01
Last updated
2026-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

Stroke, Rehabilitation, Virtual Reality, Mixed reality, Extended reality

Brief summary

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.

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.

Interventions

DEVICERehAtt 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.

Sponsors

Värmland County Council, Sweden
Lead SponsorOTHER_GOV
Örebro University, Sweden
CollaboratorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

This study uses a single-group, Single-Case Experimental Design (SCED).

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Fugl-Meyer Assessment Lower Extremity (FMA-LE)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.
Action Research Arm Test (ARAT)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.
Timed Up and Go Test (TUG)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.
10-Meter Walk Test (10MWT)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

MeasureTime frameDescription
Barthel IndexAssessed 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.
RAND-36Assessed 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.

Countries

Sweden

Contacts

CONTACTIngela Marklund, Senior Physiotherapist, PhD.
ingela.marklund@regionvarmland.se+4610-8314216
CONTACTDana Islam, physiotherapist, PhD student
dana.islam@regionvarmland.se+4610-8315777

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 11, 2026