Evaluation of the effect of immersive virtual reality-based upper extremity rehabilitation in hemiparesis and hemiplegia compared to standard therapeutic care: A randomized controlled trial.
- Conditions
- Flaccid hemiplegiaG81.0G81.9G81.1Hemiplegia, unspecifiedSpastic hemiplegia
- Registration Number
- DRKS00026242
- Lead Sponsor
- ReHub GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 112
One of the following diagnoses:
- ICD10 G81.0: Flaccid hemiparesis and hemiplegia.
- ICD10 G81.1: Spastic hemiparesis and hemiplegia
- ICD10 G81.9: Hemiparesis and hemiplegia, unspecified
- First cerebrovascular brain injury (stroke) 3 to 12 months ago
- Age range: 40-70 years
- Ability to sit without support for more than 10 seconds
- Ability to follow simple verbal instructions
- No previous experience with Rehago or any other VR therapy app
- Sufficient knowledge of German to operate the app
- Explicit consent to participate in the study
- Symptomatic neurologic pre-condition, especially chronic progressive or recurrent like Multiple sclerosis or severe Muscle diseases
- Heart failure
- debilitating chronic dizziness
- Impaired vision
- Severe intellectual disability or dementia
- Mental illness with delusional perceptual processing
- Photosensitive Epilepsy
- Bilateral pareses of upper extremity
- Severe Aphasia that prevents the use of the therapeutic device
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Functional Independence Measure (FIM) - all subgroups. Done on Day 0, 14, 28 and 42.
- Secondary Outcome Measures
Name Time Method Adherence, EQ5D-5L, MMST, FMA, NNM.<br>Adherence is documented daily via diary. EQ5D-5L is completed weekly by the patients. FMA and NNM are completed every 14 days (day 0, 14, 28, 42) with therapist(s) and patient(s). The Mini Mental State Test (MMST) will be administered on day 0 and day 42.