Status:
COMPLETED
Arm Motor Rehabilitation, Entertainment and Cognition System for the Elderly (Clinical Trial)
Lead Sponsor:
Bright Cloud International Corp
Collaborating Sponsors:
Kessler Foundation
National Institute on Aging (NIA)
Conditions:
Acute Stroke
Eligibility:
All Genders
50-85 years
Phase:
NA
Brief Summary
The research project is intended to provide information pertaining to the usability, feasibility and clinical benefit of the BAC system for early sub-acute post CVA rehabilitation, improved cognition ...
Detailed Description
This study targets participants, who had suffered a stroke very recently, who may or may not have been diagnosed with mild cognitive impairments or dementia (including Alzheimer's disease). It is impo...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
March 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2019
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04724954
Start Date
March 1 2019
End Date
December 31 2019
Last Update
July 21 2021
Active Locations (2)
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1
Bright Cloud Int'l Corp
North Brunswick, New Jersey, United States, 08902
2
Kessler Foundation
West Orange, New Jersey, United States, 07052