Arm Motor Rehabilitation, Entertainment and Cognition System for the Elderly

NCT04252170 | Completed FDA Device

• 2 other identifiers: BCI-10-0015R44AG044639-05
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (4)

• 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

  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.

  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).

  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)

  3 weeks

Secondary Outcomes (18)

• Arm Range of Motion

  Change from Baseline arm range of motion at 3 weeks

• Finger Range of Motion

  Change from Baseline finger 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

• Shoulder strength

  Change from Baseline shoulder strength at 3 weeks

Study Arms (1)

Feasibility study, Stroke Survivors

EXPERIMENTAL

BAC feasibility study at PowerBack, Piscataway NJ, with stroke patients.

Device: Rehabilitation Therapy, Experimental on the BrightArm Compact device

Interventions

Rehabilitation Therapy, Experimental on the BrightArm Compact device DEVICE

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.

Also known as: BrightArm Compact rehabilitation through games

Feasibility study, Stroke Survivors

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Bright Cloud International Corp: lead
• National Institute on Aging (NIA): collaborator
• Genesis HealthCare System: collaborator

Study Sites (1)

PowerBack Rehabilitation

Piscataway, New Jersey, 08854, United States

Location

Related Publications (1)

• 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.

  PMID: 35416787 DERIVED

Related Links

• BCI's corporate site

MeSH Terms

Conditions

Stroke

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Grigore C Burdea, Ph.D.

  BRIGHT CLOUD INTL CORP

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Engineering

Model Details: 6 will be stroke survivors inpatients at PowerBack, Piscataway NJ, USA.

Study Record Dates

• First Submitted: January 22, 2020
• First Posted: February 5, 2020
• Study Start: September 15, 2018
• Primary Completion: December 31, 2018
• Study Completion: January 31, 2019
• Last Updated: February 5, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)