Arm Motor Rehabilitation, Entertainment and Cognition System for the Elderly (Clinical Trial)
Acute Stroke

About this trial
This is an interventional treatment trial for Acute Stroke focused on measuring acute stroke, sub-acute stage
Eligibility Criteria
Inclusion Criteria (general)
- Age 50 to 85;
- Healthy age-matched volunteers
- diagnosis of CVA that occurred more than 5 days prior and less than 21 days prior (for the stroke survivors group);
- 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 10o for shoulder and elbow flexion/extension;
- ability to actively extend fingers at least 5o
- cognitive skills to participate (Montreal Cognitive Assessment (MoCA) [Nasreddine et al 2005] score 10-30).
- The adaptive nature of BBC system hardware and therapeutic games can compensate for the motor limitations due to other co-morbidities. Therefore potential participants will not be excluded due to co-morbidities such as Parkinson or arthritis.
Subjects may have normal cognition, MCI or dementia, since the games can compensate for diminished cognition through built-in cues and instructions.
Inclusion Criterion for the controlled clinical trials arm at Kessler Foundation
• Living within 25 miles radius of Kessler Foundation West Orange location. This will facilitate participation in the outpatient clinic training, which follows inpatient rehabilitation.
Exclusion Criteria. (general)
- being younger than 50 or older than 85 years of age
- previous stroke
- Stroke that occurred more than 20 days prior to enrolment
- Inability to actively extend fingers at least 5 degrees; v. 7/8/2018
- 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 behaviour.
- inability participate in the neuropsychological pre-study assessment for reliable scores (e.g., cognitive impairment, communication disorders).
Exclusion Criteria. (Controlled study arm)
o Those living outside approximately 25 miles radius of Kessler Foundation West Orange location. Those living too far will have a harder time completing the study as outpatients, as they will probably choose clinics closer to home.
Sites / Locations
- Bright Cloud Int'l Corp
- Kessler Foundation
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
Rehabilitation Therapy on Experimental Robotic Table and standard of care
Rehabilitation Therapy as part of Standard of Care
10 elderly 5 days or more post-CVA admitted to Kessler Institute for Rehabilitation/Kessler Foundation) for inpatient rehabilitation will be recruited for experimental group. The investigators will also recruit the 10 caregivers of the experimental subjects. Both experimental and control groups will undergo standardized evaluations for motor function/impairment, cognition and emotive states.
10 elderly 5 days or more post-CVA admitted to Kessler Institute for Rehabilitation/Kessler Foundation) for inpatient rehabilitation will be recruited as a control group. The investigators will also recruit the 10 caregivers of the control subjects. Both experimental and control groups will undergo standardized evaluations for motor function/impairment, cognition and emotive states.