Stroke Rehabilitation Using Extended Reality.
ConditionStroke
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVärmland County Council, Sweden
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
• 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
Trial design
Design model
Single group
Treatments tested in this trial
RehAtt XR System
DeviceParticipants 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.
Treatment groups
9 Participants
are divided into 1 treatment groupGroup A: XR-Based Stroke RehabilitationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
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.2
Action Research Arm Test (ARAT)
Assessment of upper extremity activity capacity and manual dexterity. Higher scores indicate better upper limb function.
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.3
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.
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.4
10-Meter Walk Test (10MWT)
Assessment of walking speed over a 10-meter distance. Higher walking speed indicates better gait performance.
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.Secondary outcomes
1
Barthel Index
Assessment of independence in activities of daily living. Higher scores indicate greater independence.
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.2
RAND-36
Assessment of health-related quality of life across multiple domains. Higher scores indicate better perceived health status.
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.Other outcomes
1
Participants' Experiences of XR-Based Rehabilitation
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.
Time frame
End of intervention, 3-month follow-up, and 6-month follow-up.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Värmland County Council, Sweden
Lead sponsor
Örebro University, Sweden
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: