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

NCT04724954 | Completed FDA Device

• 2 other identifiers: Phase IIB Clinical TrialR44AG044639
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

acute stroke; sub-acute stage

Outcome Measures

Primary Outcomes (2)

• Change in Fugl-Meyer Assessment score for upper extremity function (UE sub-set)

  Upper Extremity Mobility and function. It is scored from 0 (minimum score) to 66 (maximum). The higher the score, the better, with 66 indicating normal upper extremity function.

  Change between baseline, at 3 weeks and at 5 weeks post enrollment

• Change in Cognitive executive function assessment score

  Trail Making Test B (TMT-B), Neuropsychological Assessment Battery (NAB) Executive Functioning Module. This is a timed test (seconds) with less time indicative of better executive function. No scale.

  Change between baseline, at 3 weeks and at 5 weeks post enrollment

Secondary Outcomes (14)

• Change in Arm Range of Motion

  Change between baseline, at 3 weeks and at 5 weeks post enrollment

• Change in Grasp strength for whole hand (power grasp) and finger pinch

  Change between baseline, at 3 weeks and at 5 weeks post enrollment

• Change in Finger Range of Motion measured with mechanical goniometer

  Change between baseline, at 3 weeks and at 5 weeks post enrollment

• Change in Upper extremity functional index (UEFI-20) of independence in activities of daily living

  Change between baseline, at 3 weeks and at 5 weeks post enrollment

• Change in Stroke Impact Scale (SIS) measuring impact of stroke on independence in daily activities

  Change between baseline, at 3 weeks and at 5 weeks post enrollment

Other Outcomes (6)

• Change in Verbal memory as measured by Hopkins Verbal Learning Test, Revised

  Change between baseline, at 3 weeks and at 5 weeks post enrollment

• Change in visuospatial memory as measured by Brief Visuospatial Memory Test, Revised (BVMT-R)

  Change between baseline, at 3 weeks and at 5 weeks post enrollment

• Change in cognitive function as measured by the Montreal Cognitive Assessment Test score

  Change between baseline, at 3 weeks and at 5 weeks post enrollment

Study Arms (2)

Rehabilitation Therapy on Experimental Robotic Table and standard of care

EXPERIMENTAL

10 elderly 5 days or more post-CVA admitted to Kessler Institute for Rehabilitation/Kessler Foundation) for inpatient rehabilitation will be recruited for experimental group. The investigators will also recruit the 10 caregivers of the experimental subjects. Both experimental and control groups will undergo standardized evaluations for motor function/impairment, cognition and emotive states.

Device: Rehabilitation Therapy on Experimental Robotic Table and standard of care

Rehabilitation Therapy as part of Standard of Care

SHAM COMPARATOR

10 elderly 5 days or more post-CVA admitted to Kessler Institute for Rehabilitation/Kessler Foundation) for inpatient rehabilitation will be recruited as a control group. The investigators will also recruit the 10 caregivers of the control subjects. Both experimental and control groups will undergo standardized evaluations for motor function/impairment, cognition and emotive states.

Genetic: Rehabilitation Therapy as part of Standard of Care (Control)

Interventions

Rehabilitation Therapy on Experimental Robotic Table and standard of care DEVICE

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

Also known as: BrightArm Compact Rehabilitation

Rehabilitation Therapy on Experimental Robotic Table and standard of care

Rehabilitation Therapy as part of Standard of Care (Control) GENETIC

Control group will receive Standard of Care training only

Rehabilitation Therapy as part of Standard of Care

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;
• Healthy age-matched volunteers
• diagnosis of CVA that occurred more than 5 days prior and less than 21 days prior (for the stroke survivors group);
• 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 10o for shoulder and elbow flexion/extension;
• ability to actively extend fingers at least 5o
• cognitive skills to participate (Montreal Cognitive Assessment (MoCA) \[Nasreddine et al 2005\] score 10-30).
• The adaptive nature of BBC system hardware and therapeutic games can compensate for the motor limitations due to other co-morbidities. Therefore potential participants will not be excluded due to co-morbidities such as Parkinson or arthritis.
• Subjects may have normal cognition, MCI or dementia, since the games can compensate for diminished cognition through built-in cues and instructions.
• Living within 25 miles radius of Kessler Foundation West Orange location. This will facilitate participation in the outpatient clinic training, which follows inpatient rehabilitation.

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 enrolment
• Inability to actively extend fingers at least 5 degrees; v. 7/8/2018
• 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
• Kessler Foundation: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (2)

Bright Cloud Int'l Corp

North Brunswick, New Jersey, 08902, United States

Location

Kessler Foundation

West Orange, New Jersey, 07052, United States

Location

Related Links

• BCI's corporate site showing therapeutic games used with the device

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, PhD

  Bright Cloud International Corp

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Technology Officer

Model Details: Number of subjects: The Investigators expect to enroll up to 40 subjects, inpatients and then outpatients at a research hospital and its outpatient clinic at Kessler Foundation: 20 stroke patients, and 20 will be their spouses/caregivers of subjects participating in the randomized control trials component of this study.

Study Record Dates

• First Submitted: January 12, 2021
• First Posted: January 26, 2021
• Study Start: March 1, 2019
• Primary Completion: June 15, 2019
• Study Completion: December 31, 2019
• Last Updated: July 21, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)