Arm Motor Rehabilitation, Entertainment and Cognition System for the Elderly (Feasibility Study)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Stroke
- Sponsor
- Bright Cloud International Corp
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- Game Score (baseline and performance)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Detailed Description
This study targets participants, who had suffered a first stroke recently, and 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) bilateral rehabilitation developed by Bright Cloud International Corp, and if these gains transfer to daily activities. Specific aims are: * BAC technology acceptance; * improvement in motor function for the upper extremity; * strengthening of shoulder and fingers; * increased active (self initiated) range of motion for shoulder, arms and fingers; * improved independence in activities of daily living; * improvement in cognitive areas of memory, attention and decision making; * improved mood (as in reduced depression severity);
Investigators
Dr. Nam H. Kim
Director of Engineering
Bright Cloud International Corp
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Game Score (baseline and performance)
Time Frame: Through study completion, an average of 3 weeks
BrightBrainer game baseline and performance scores. Min. score is 0. Max depends on specific game.
Participants' feedback using 5-point Likert scale
Time Frame: Through study completion, an average of 3 weeks
Subjective evaluation feedback and overall ratings on BrightBrainer games. Consists of multiple questions, each ranked on a 5-point Likert scale, with 1 (min) and 5 (max).
Artificial Intelligence-determined game difficulty level
Time Frame: Through study completion, an average of 3 weeks
BrightBrainer game difficulty setting is determined based on patient's past performance, in order to adapt the therapy to a given individual. It representing an average or difficulties of all games played in a session. The measure implies game play intensity and level of challenge
Therapist subjective evaluation using 5-point Likert scale
Time Frame: 3 weeks
Subjective evaluation given by the attending Occupational Therapist at the end of the experimental intervention. Multiple questions, each ranked from 1 (min) to 5 (max)
Secondary Outcomes
- Arm Range of Motion(Change from Baseline arm range of motion at 3 weeks)
- Grasp Strength with Jamar Dynamo-meter(Change from Baseline grasp strength at 3 weeks)
- Pinch strength with pinch meter(Change from Baseline at 3 weeks)
- Jebsen Test of Hand Function(Change from Baseline Jebsen Test of Hand Function score at 3 weeks)
- Verbal attention(Change from Baseline verbal attention at 3 weeks)
- CAHAI 9 Score(Change from Baseline CAHAI 9 score at 3 weeks)
- Fugl-Meyer Assessment (Upper Extremity sub-scale) score(Change from Baseline Fugl-Meyer Assessment Score at 3 weeks)
- Upper extremity functional index (UEFI) score(Change from Baseline Upper Extremity Functional Inex score at 3 weeks)
- Brief Visuospatial Memory Test-Revised(Change from Baseline visuospatial memory at 3 weeks)
- Finger Range of Motion(Change from Baseline finger range of motion at 3 weeks)
- Shoulder strength(Change from Baseline shoulder strength at 3 weeks)
- Beck Depression Inventory II (BDI II) score(Change from Baseline depression severity at 3 weeks)
- Verbal fluency(Change from Baseline verbal fluency at 3 weeks)
- Verbal memory(Change from Baseline verbal learning memory at 3 weeks)
- Cognitive executive function(Change from Baseline NAB Exec Score at 3 weeks)
- Visual attention(Change from Baseline visual attention at 3 weeks)
- Executive Function Module(Change from Baseline executive function at 3 weeks)