Arm Motor Rehabilitation, Entertainment and Cognition System for the Elderly
Completed · Not applicable
Conditions studied: Stroke
In brief
The research project is intended to provide information pertaining to the feasibility of the BrightArm Compact robotic rehabilitation system for patients early sub-acute post Cerebral Vascular Accident. The aims are to: a) determine clinical benefit to motor and cognitive function as well as mood; 2) to ascertain technology acceptance by patients and therapists. The experimental training consists of 12 integrative arm/hand and cognitive training by playing therapeutic games. Participants are evaluated pre-and post-intervention and provide subjective evaluation of the system.
Key facts
- Study ID
- NCT04252170
- Run by
- Bright Cloud International Corp
- People needed
- 2
- Starts
- 2018-09-15
- Expected to finish
- 2019-01-31
- Last updated by the study team
- 2020-02-05
Who can join
Age: 50 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 50 to 85;
- diagnosis of first-time CVA that occurred more than 5 days prior and less than 21 days prior
- English speakers;
- UE unilateral or bilateral involvement (from new bilateral CVA)
- motor involvement (FMA score 20 to 45);
- ability to actively move UE more than 10 degrees for shoulder and elbow flexion/extension;
- ability to actively extend fingers at least 5 degrees
- cognitive skills to participate (Montreal Cognitive Assessment (MoCA) [Nasreddine et al 2005] score 10-30).
- Subjects may have normal cognition, MCI or dementia
You may not qualify if…
- being younger than 50 or older than 85 years of age
- previous stroke
- Stroke that occurred more than 20 days prior to enrollment
- Inability to actively extend fingers at least 5 degrees;
- Fugl-Meyer scores of 19 or less;
- severe visual neglect or legally blind
- severe hearing loss or deafness
- receptive aphasia or severe expressive aphasia;
- severe spasticity (Modified Ashworth Scale 4/4)
- contractures of the upper limb joints
- uncontrolled hypertension (>190/100 mmHg)
- severe cognitive impairment determined by Montreal Cognitive Assessment (MoCA) [Nasreddine et al, 2005] test of 9 and below;
- No chemodenervation or nerve block to upper limb involved during the experimental period (e.g., botulinum toxin injection)
- inability to speak English;
- a history of violence or drug abuse;
- paranoia and psychotic behavior;
- inability participate in the neuropsychological pre-study assessment for reliable scores (e.g., cognitive impairment, communication disorders).
Where it is running
- PowerBack Rehabilitation — Piscataway, New Jersey, United States
Full record on ClinicalTrials.gov
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