Clinical trial NCT04252170: Arm Motor Rehabilitation, Entertainment and Cognition System for the Elderly
Official title: Arm Motor Rehabilitation, Entertainment and Cognition System for the Elderly (Feasibility Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Bright Cloud International Corp
Sponsor class: INDUSTRY
Collaborators: name: National Institute on Aging (NIA)
name: Genesis HealthCare System
First posted: 2020-02-05
Enrollment: 2
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 6 will be stroke survivors inpatients at PowerBack, Piscataway NJ, USA.
Primary purpose: DEVICE_FEASIBILITY

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);

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
* 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).

Primary outcomes:
measure: Artificial Intelligence-determined game difficulty level
timeFrame: Through study completion, an average of 3 weeks
measure: Game Score (baseline and performance)
timeFrame: Through study completion, an average of 3 weeks
measure: Participants' feedback using 5-point Likert scale
timeFrame: Through study completion, an average of 3 weeks
measure: Therapist subjective evaluation using 5-point Likert scale
timeFrame: 3 weeks
Secondary outcomes:
measure: Arm Range of Motion
timeFrame: Change from Baseline arm range of motion at 3 weeks
measure: Finger Range of Motion
timeFrame: Change from Baseline finger range of motion at 3 weeks
measure: Grasp Strength with Jamar Dynamo-meter
timeFrame: Change from Baseline grasp strength at 3 weeks
measure: Pinch strength with pinch meter
timeFrame: Change from Baseline at 3 weeks
measure: Shoulder strength
timeFrame: Change from Baseline shoulder strength at 3 weeks
measure: Fugl-Meyer Assessment (Upper Extremity sub-scale) score
timeFrame: Change from Baseline Fugl-Meyer Assessment Score at 3 weeks
measure: Upper extremity functional index (UEFI) score
timeFrame: Change from Baseline Upper Extremity Functional Inex score at 3 weeks
measure: CAHAI 9 Score
timeFrame: Change from Baseline CAHAI 9 score at 3 weeks
measure: Jebsen Test of Hand Function
timeFrame: Change from Baseline Jebsen Test of Hand Function score at 3 weeks
measure: Beck Depression Inventory II (BDI II) score
timeFrame: Change from Baseline depression severity at 3 weeks
measure: Verbal attention
timeFrame: Change from Baseline verbal attention at 3 weeks
measure: Verbal fluency
timeFrame: Change from Baseline verbal fluency at 3 weeks
measure: Verbal memory
timeFrame: Change from Baseline verbal learning memory at 3 weeks
measure: Brief Visuospatial Memory Test-Revised
timeFrame: Change from Baseline visuospatial memory at 3 weeks
measure: Executive Function Module
timeFrame: Change from Baseline executive function at 3 weeks
measure: Cognitive executive function
timeFrame: Change from Baseline Trail Making Test B (TMT-B) Score at 3 weeks
measure: Cognitive executive function
timeFrame: Change from Baseline NAB Exec Score at 3 weeks
measure: Visual attention
timeFrame: Change from Baseline visual attention at 3 weeks
Other outcomes:
Locations:
city: Piscataway
country: United States
facility: PowerBack Rehabilitation
state: New Jersey
Study officials:
affiliation: BRIGHT CLOUD INTL CORP
name: Grigore C Burdea, Ph.D.
role: STUDY_CHAIR
References:
citation: Burdea G, Kim N, Polistico K, Kadaru A, Grampurohit N, Hundal J, Pollack S. Robotic Table and Serious Games for Integrative Rehabilitation in the Early Poststroke Phase: Two Case Reports. JMIR Rehabil Assist Technol. 2022 Apr 13;9(2):e26990. doi: 10.2196/26990.