Remote Bimanual Virtual Rehabilitation Post CVD
Completed · Not applicable
Conditions studied: Stroke Sequelae, Cognitive Impairment, Depression
In brief
The aim of the study is to develop the BrightBrainer G (grasp), a game-based upper-extremity motor and cognitive rehabilitation system using custom virtual reality simulations. The G model is a version of the BrightBrainer Rehabilitation System, a Class 1 Exempt medical device produced by Bright Cloud International Corp (FDA owner/operator 10050478), and listed with the FDA (registration number 3012187972);
Key facts
- Study ID
- NCT04713384
- Run by
- Grigore Burdea
- People needed
- 18
- Starts
- 2015-09-30
- Expected to finish
- 2018-09-13
- Last updated by the study team
- 2021-07-21
Who can join
Age: 48 and older, up to 80. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Age 48 to 80;
- Diagnosis of stroke which occurred more than 9 months prior (i.e. in the chronic phase);
- English speakers;
- UE unilateral motor involvement (FMA score 10 to 45);
- Be able to actively move UE more than 15 degrees for shoulder and for elbow flexion/extension;
- Be more than 4 months post casting procedures or Botulinum toxin injections;
- Have cognitive skills to participate (Montreal Cognitive Assessment score 18-30).
- Potential participants will not be excluded due to co-morbidities such as Parkinson, frozen shoulder, or arthritis;
- Have normal cognition or MCI.
You may not qualify if…
- Be younger than 48 or older than 80;
- Present with severe visual neglect or legally blind;
- Have severe hearing loss or deafness;
- Present with receptive aphasia or severe expressive aphasia;
- Have uncontrolled hypertension (>190/100 mmHg);
- Have severe cognitive delay;
- Cannot speak English;
- Have history of violence or drug abuse;
- Participants who cannot produce reliable scores on the neuropsychological pre-study assessment because they do not comprehend the test, or have severe speech impairment will be excluded;
- Have severe hand spasticity and/or complete lack of arm movement;
- MoCA scores of 17 and below.
Where it is running
- Kessler Foundation — West Orange, New Jersey, United States
Full record on ClinicalTrials.gov
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