Remote Bimanual Virtual Rehabilitation Post CVD

Grigore Burdea

Status: Completed

Conditions: Cognitive Impairment; Stroke Sequelae; Depression

Treatments: Device: Integrative tele-rehalitation of chronic stroke survivors using custom therapeutic games

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04713384

Phase I Tele-Rehab

GRANT R43AG052290 (Other Grant/Funding Number)

Details and patient eligibility

About

The aim of the study is to develop the BrightBrainer G (grasp), a game-based upper-extremity motor and cognitive rehabilitation system using custom virtual reality simulations. The G model is a version of the BrightBrainer Rehabilitation System, a Class 1 Exempt medical device produced by Bright Cloud International Corp (FDA owner/operator 10050478), and listed with the FDA (registration number 3012187972);

Full description

8 elderly subjects (50 to 80 years old) who live at home and had a stroke more than 9 months prior to participation, who may also suffer from mild cognitive impairments and may be depressed, will be recruited. Their 8 caregivers will also be recruited at Kessler Foundation.

Participants will train on the BrightBrainer system for 4 weeks in their home, doing a total of 20 rehabilitation sessions. Sessions will consist of playing therapeutic games using both the impaired and unimpaired arms. Sessions will progress in duration from 20 minutes to 40 minutes of actual play. Before and after the 4 weeks home therapy, participants will travel to the Kessler Foundation (West Orange, NJ) and undergo standardized motor, cognitive, and emotive clinical evaluations.

Enrollment: 18 patients

Sex: All

Ages: 48 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 48 to 80;
• Diagnosis of stroke which occurred more than 9 months prior (i.e. in the chronic phase);
• English speakers;
• UE unilateral motor involvement (FMA score 10 to 45);
• Be able to actively move UE more than 15 degrees for shoulder and for elbow flexion/extension;
• Be more than 4 months post casting procedures or Botulinum toxin injections;
• Have cognitive skills to participate (Montreal Cognitive Assessment score 18-30).
• Potential participants will not be excluded due to co-morbidities such as Parkinson, frozen shoulder, or arthritis;
• Have normal cognition or MCI.

Exclusion criteria

• Be younger than 48 or older than 80;
• Present with severe visual neglect or legally blind;
• Have severe hearing loss or deafness;
• Present with receptive aphasia or severe expressive aphasia;
• Have uncontrolled hypertension (>190/100 mmHg);
• Have severe cognitive delay;
• Cannot speak English;
• Have history of violence or drug abuse;
• Participants who cannot produce reliable scores on the neuropsychological pre-study assessment because they do not comprehend the test, or have severe speech impairment will be excluded;
• Have severe hand spasticity and/or complete lack of arm movement;
• MoCA scores of 17 and below.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Treatment

Experimental group

Description:

Participants will undergo 4 weeks (20 sessions) of experimental rehabilitation in their home. They will play custom therapeutic games that are intensive and adapt to their condition. Before and after the 4-week intervention participants will travel to Kessler Foundation to undergo evaluations. The therapy is designed to improve arm range, strength, endurance, as well as memory, focusing and decision making. Data will be stored on the cloud, protected and monitored by the research team.

Treatment:

Device: Integrative tele-rehalitation of chronic stroke survivors using custom therapeutic games