Remote Bimanual Virtual Rehabilitation Post CVD

NCT04713384 | Completed DMC

• 2 other identifiers: Phase I Tele-RehabGRANT R43AG052290
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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);

Conditions

Stroke Sequelae; Cognitive Impairment; Depression

Keywords

virtual reality; stroke; upper extremity; BrightBrainer; rehabilitation; home; gamification

Outcome Measures

Primary Outcomes (2)

• Fugl-Meyer Assessment of Upper Extremity Function (Upper Extremity Sub-scale)

  Upper Extremity motor function Sub-Scale: 0 (completely impaired) to 66 (normal).

  Change from baseline at 4 weeks

• Trail Making Test B (TMT-B) (raw score) measure of cognitive executive function

  Timed test measures the subject's executive function. Subject is asked to connect dots of a page (with associated digits) in increasing magnitude, in the shortest time. Less time (measured in seconds) is better.

  Change from baseline at 4 weeks

Secondary Outcomes (23)

• Upper extremity functional index (UEFI) self-report of independence in daily activities

  Change from baseline at 4 weeks

• Chedoke Arm and Hand Activity Inventory (CAHAI) 9 measure of independence in bimanual daily activities

  Change from baseline at 4 weeks

• Arm range of motion (degrees) measure for shoulder, elbow, wrist and fingers

  Change from baseline at 4 weeks

• Shoulder strength for deltoid muscles

  Change from baseline at 4 weeks

• Grasp strength for power grasps and pinch grasps

  Change from baseline at 4 weeks

Study Arms (1)

Treatment

EXPERIMENTAL

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.

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

Interventions

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

20 sessions of playing therapeutic games using both arms while siting at a table at home. Arms hold either generic game controllers, or BrightBrainer therapeutic controllers. Sessions involve a variety of games that train motor and cognitive function in an integrative way. The games are rendered by the BrightBrainer system. Games adapt and are winnable, benefiting well-being (reducing depression). Each session may generate many hundreds of arm repetitions, finger movement and grasps, depending on session duration. Data on arm reach as well as game outcomes and vitals are uploaded to an secure server. These data allow researchers to remotely monitor compliance to protocol and longitudinal progress. Caregivers are present at each session, and provide feedback as well as subjective ratings of the system.

Also known as: BrightBrainer using BrightBrainer Grasp therapeutic controller

Treatment

Eligibility Criteria

• Age: 48 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Grigore Burdea: lead
• Kessler Foundation: collaborator

Study Sites (1)

Kessler Foundation

West Orange, New Jersey, 07052, United States

Location

Related Links

• site showing device

MeSH Terms

Conditions

Cognitive Dysfunction; Depression; Stroke

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• AM Barrett, MD

  Kessler Foundation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Technology Officer

Model Details: 20 elderly subjects. Or these 4 healthy age-matched volunteers for usability, and 8 elderly stroke survivors to determine technology acceptance and clinical benefit to motor, cognitive and emotive function, under remote rehabilitation conditions. We will also recruit their 8 caregivers so to have better feedback in changes they observe in the stroke survivors and any technology issues. Among them, one patient dropped, 7 patients (and their caregivers) completed the study. The subjects in this feasibility study will have UE motor impairments, normal cognition or have Mild Cognitive Impairment (MCI). Pre- and Post-intervention standardized evaluations will be used to determine benefit. Subjective evaluations and adherence to protocol will indicate acceptance of the technology. Each session of game exercises will store performance data, which will be monitored remotely.

Study Record Dates

• First Submitted: June 22, 2018
• First Posted: January 19, 2021
• Study Start: September 30, 2015
• Primary Completion: August 31, 2018
• Study Completion: September 13, 2018
• Last Updated: July 21, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)