MedTrace Logo

Arm Motor Rehabilitation, Entertainment and Cognition System for the Elderly (Clinical Trial)

NCT04724954 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2021-07-21

No results posted yet for this study

Summary

The research project is intended to provide information pertaining to the usability, feasibility and clinical benefit of the BAC system for early sub-acute post CVA rehabilitation, improved cognition and emotive state while in acute inpatient rehabilitation settings (Kessler Foundation) and in an outpatient clinic at the same research hospital.

The randomised controlled trials will take place at Kessler Foundation (West Orange, NJ). It will develop a new longitudinal therapy for elderly stroke survivors who are inpatients and then outpatients at a regional rehabilitation hospital, by adding BAC training to customary care for both inpatients and outpatients. Two systems will be used, improving continuity of care (one each for inpatient and outpatient settings).

Conditions

  • Acute Stroke

Interventions

DEVICE

Rehabilitation Therapy on Experimental Robotic Table and standard of care

Experimental group will receive VR game-based rehabilitation therapy through Bright Cloud's proprietary device, called BrightArm Compact (BAC). They will also receive Standard of Care rehabilitation

GENETIC

Rehabilitation Therapy as part of Standard of Care (Control)

Control group will receive Standard of Care training only

Sponsors & Collaborators

  • Kessler Foundation

    collaborator OTHER

  • National Institute on Aging (NIA)

    collaborator NIH

  • Bright Cloud International Corp

    lead INDUSTRY

Principal Investigators

  • Grigore C Burdea, PhD · Bright Cloud International Corp

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-01
Primary Completion
2019-06-15
Completion
2019-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04724954 on ClinicalTrials.gov