Arm Motor Rehabilitation, Entertainment and Cognition System for the Elderly

Bright Cloud International Corp2 enrolled

Overview

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.

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);

Study Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Stroke

Interventions

Rehabilitation Therapy, Experimental on the BrightArm Compact deviceDEVICE

Experimental group will receive VR game-based rehabilitation therapy through Bright Cloud's proprietary device, called BrightArm Compact (BAC). An Occupational Therapist will assist as needed.

Eligibility

Sex: ALLMin age: 50 YearsMax age: 85 Years

Medical Language ↔ Plain English

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).

Locations (1)

PowerBack Rehabilitation

Piscataway, New Jersey, United States

Outcomes

Primary Outcomes

Artificial Intelligence-determined game difficulty level

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

Time frame: Through study completion, an average of 3 weeks

Game Score (baseline and performance)

BrightBrainer game baseline and performance scores. Min. score is 0. Max depends on specific game.

Time frame: Through study completion, an average of 3 weeks

Participants' feedback using 5-point Likert scale

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).

Time frame: Through study completion, an average of 3 weeks

Therapist subjective evaluation using 5-point Likert scale

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)

Time frame: 3 weeks

Secondary Outcomes

Arm Range of Motion

measurement of active movement initiated by participant using a mechanical goniometer

Time frame: Change from Baseline arm range of motion at 3 weeks

Finger Range of Motion

finger extension/flexion range using a mechanical goniomter

Time frame: Change from Baseline finger range of motion at 3 weeks

Data from ClinicalTrials.gov

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