Arm Motor Rehabilitation, Entertainment and Cognition System for the Elderly (Clinical Trial)
- Conditions
- Acute Stroke
- Interventions
- Genetic: Rehabilitation Therapy as part of Standard of Care (Control)Device: Rehabilitation Therapy on Experimental Robotic Table and standard of care
- Registration Number
- NCT04724954
- Lead Sponsor
- Bright Cloud International Corp
- 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 and emotive state while in acute inpatient rehabilitation settings (Kessler Foundation) and in an outpatient clinic at the same research hospital.
The randomised controlled trials will take place at Kessler Foundation (West Orange, NJ). It will develop a new longitudinal therapy for elderly stroke survivors who are inpatients and then outpatients at a regional rehabilitation hospital, by adding BAC training to customary care for both inpatients and outpatients. Two systems will be used, improving continuity of care (one each for inpatient and outpatient settings).
- 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 important to find out if these improvements can be obtained with the computer game-based integrative (motor-cognitive) bimanual rehabilitation developed by Bright Cloud International Corp, and if these gains transfer to daily activities. The study also aims at determining benefit of continuum care training on the BAC in addition to conventional rehabilitation for participants who are inpatients and then outpatients at a rehabilitation hospital and clinic.
Specific aims are:
BAC technology acceptance (all groups); improved motor function for upper extremity; strengthening shoulder and fingers increased range of motion for arms and fingers; improved independence in activities of daily living; improved cognition; improved emotive state; reduction in perceived upper body pain.
Another component of the research project is a small pilot targeting individuals with Parkinson's disease. For them the project is going to:
determine technology acceptance when using the BrightBrainer system; benefit to arms motor function and strengthening when playing BCI therapeutic games; benefit to reduction or tremor when playing games; cognitive benefits improvement in their well-being.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 6
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Rehabilitation Therapy as part of Standard of Care Rehabilitation Therapy as part of Standard of Care (Control) 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. Rehabilitation Therapy on Experimental Robotic Table and standard of care Rehabilitation Therapy on Experimental Robotic Table and 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.
- Primary Outcome Measures
Name Time Method Change in Fugl-Meyer Assessment score for upper extremity function (UE sub-set) Change between baseline, at 3 weeks and at 5 weeks post enrollment Upper Extremity Mobility and function. It is scored from 0 (minimum score) to 66 (maximum). The higher the score, the better, with 66 indicating normal upper extremity function.
Change in Cognitive executive function assessment score Change between baseline, at 3 weeks and at 5 weeks post enrollment Trail Making Test B (TMT-B), Neuropsychological Assessment Battery (NAB) Executive Functioning Module. This is a timed test (seconds) with less time indicative of better executive function. No scale.
- Secondary Outcome Measures
Name Time Method Change in Upper extremity functional index (UEFI-20) of independence in activities of daily living Change between baseline, at 3 weeks and at 5 weeks post enrollment Self report of degree of independence in activities of daily living (ADLs). Consists of 20 questions, each scored on a 5 point scale with 0 complete dependence (unable to perform task) to 4 independence in a tasks. Minimum score is 0 (subjects is unable to perform any of the 20 listed tasks to 80 complete independence in all 20 ADLs. Higher score is better outcome.
Change in Verbal attention as measured by the Neuropsychological Assessment Battery Change between baseline, at 3 weeks and at 5 weeks post enrollment Attention module digit span tests verbal attention when subject is spoken a sequence of digits, then asked to repeat that sequence. Subjects is spoken 10 sequences of increasing length of digits (between 1 and 9). Score is 1 if sequence is repeated correctly, 0 otherwise. Min score 0 means no spoken digit sequence was repeated correctly, 10 is maximum score, all sequences were repeated correctly by subject.
Change in Arm Range of Motion Change between baseline, at 3 weeks and at 5 weeks post enrollment Measurement of active movement range for shoulder, elbow, and wrist. Measured with a mechanical goniometer, higher angular values indicating larger movement range.
Change in Grasp strength for whole hand (power grasp) and finger pinch Change between baseline, at 3 weeks and at 5 weeks post enrollment Grasp strength and pinch strength measurements using dynamo-meter and pinch meter, respectively. Measured three times for maximal exertion, then averaged. Higher values are better, indicating less hand weakness.
Change in Finger Range of Motion measured with mechanical goniometer Change between baseline, at 3 weeks and at 5 weeks post enrollment finger extension/flexion range for proximal-metacarpal joints. Measured with mechanical goniometer
Change in CAHAI 9 Score of independence in bimanual ADLs Change between baseline, at 3 weeks and at 5 weeks post enrollment Chedoke Arm and Hand Activity Inventory, reflecting ADL independence in simulated bimanual ADLs. It consists of 9 tasks, each scored from 1 to 7, where 1 indicates need for total assistance (typical of very weak arms) to 7 indicating total independence in the task. Score range is 9 (minimum) to 63 (maximum)
Game % Score (baseline and performance) in therapeutic games through study completion, an average 5 weeks from enrollment BrightBrainer game performance %, with each game being scored individually. Scores converted to % of task achieved with range of 0% (worst outcome) to 100% (best outcomes).
Change in Beck Depression Inventory II (BDI II) score, a measure of depression severity Change between baseline, at 3 weeks and at 5 weeks post enrollment participants' depression measure with higher scores indicating higher severity (worse mood). Score range is 0 to 63, with 0 indicating normal mood (no depression), 1-13 minimal depression, 14-19 mild depression, 20-28 for moderate and 29-63 severe depression.
Change in Stroke Impact Scale (SIS) measuring impact of stroke on independence in daily activities Change between baseline, at 3 weeks and at 5 weeks post enrollment Self report of degree of independence in activities of daily living (ADLs). Consists of questions, each scored on a 5 point Likert scale with 1 complete dependence (unable to perform task) to 5 independence in a tasks. Minimum score is 0 (subjects is unable to perform any of the 20 listed tasks to 80 complete independence in all 20 ADLs.
Game difficulty levels through study completion, an average 5 weeks from enrollment BrightBrainer game difficulty settings, indicating game play intensity and challenge. Each game has levels from 1 (easiest) to 10 (hardest). Higher difficulty the subjects is able to play a game at represents a better outcome.
Average game difficulty levels per session through study completion, an average 5 weeks from enrollment BrightBrainer game difficulty averaged for all games played in a session. Higher average difficulty is indicative of higher function with 1 (easiest) to 10 (hardest). Higher average game difficulty represents a better outcome.
Participants' feedback through subjective evaluation of the system at 3 weeks and at 5 weeks post enrollment Subject feedback and overall ratings on BrightBrainer games, rated on a Likert scale with 1 being least desirable (strongly disagree) to 5 being most desirable rating (strongly agree).
Change in visual attention as measured by Neuropsychological Assessment Battery Change between baseline, at 3 weeks and at 5 weeks post enrollment Visual attention measured with the dots test of the Neuropsychological Assessment Battery (NAB). This is a delayed recognition span paradigm, in which an array of dots is exposed for a brief period, followed by a blank interference page, followed by a new array with one additional dot. The subject needs to point to the "new" dot. Test administered 3 times, minimum score 0 (none of the new dots found) to maximum 3 (all 3 new dots found).
Caregiver evaluation of experimental system at 5 weeks from enrolment Rating of system perceived benefit to the person the caregiver cares for. Rating uses a Likert scale with 1 being least desirable outcome and 5 most desirable one.
Trial Locations
- Locations (2)
Bright Cloud Int'l Corp
🇺🇸North Brunswick, New Jersey, United States
Kessler Foundation
🇺🇸West Orange, New Jersey, United States