Stroke Rehabilitation Using Extended Reality.

NCT07811440 | Not Yet Recruiting

• 1 other identifier: CIV-ID 26-04-057614
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Stroke; Rehabilitation; Virtual Reality; Mixed reality; Extended reality

Outcome Measures

Primary Outcomes (4)

• Fugl-Meyer Assessment Lower Extremity (FMA-LE)

  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)

  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)

  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)

  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 Outcomes (2)

• Barthel Index

  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

  Assessed at four time points: the initial baseline assessment, immediately post-intervention, and at 3 and 6 months following completion of the intervention.

Other Outcomes (1)

• Participants' Experiences of XR-Based Rehabilitation

  End of intervention, 3-month follow-up, and 6-month follow-up.

Study Arms (1)

XR-Based Stroke Rehabilitation

EXPERIMENTAL

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

Interventions

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.

XR-Based Stroke Rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Värmland County Council, Sweden: lead
• Örebro University, Sweden: collaborator

Study Sites (1)

Rehabilitation Unit, Torsby Hospital

Torsby, Värmland County, Sweden

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Ingela Marklund, Senior Physiotherapist, PhD.

CONTACT

+4610-8314216; ingela.marklund@regionvarmland.se

Dana Islam, physiotherapist, PhD student

CONTACT

+4610-8315777; dana.islam@regionvarmland.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: August 31, 2026
• First Posted: September 10, 2026
• Study Start (Estimated): September 1, 2027
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: September 10, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)