Clinical trial NCT04724954: Arm Motor Rehabilitation, Entertainment and Cognition System for the Elderly (Clinical Trial)
Official title: Arm Motor Rehabilitation, Entertainment and Cognition System for the Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Stroke
Keywords: acute stroke
sub-acute stage
Lead sponsor: Bright Cloud International Corp
Sponsor class: INDUSTRY
Collaborators: name: Kessler Foundation
name: National Institute on Aging (NIA)
First posted: 2021-01-26
Enrollment: 6
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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).

Detailed description: This study targets participants, who had suffered a stroke very recently, who may or may not have been diagnosed with mild cognitive impairments or dementia (including Alzheimer's disease). It is important to find out if these improvements can be obtained with the computer game-based integrative (motor-cognitive) bimanual rehabilitation developed by Bright Cloud International Corp, and if these gains transfer to daily activities. The study also aims at determining benefit of continuum care training on the BAC in addition to conventional rehabilitation for participants who are inpatients and then outpatients at a rehabilitation hospital and clinic.

Specific aims are:

BAC technology acceptance (all groups); improved motor function for upper extremity; strengthening shoulder and fingers increased range of motion for arms and fingers; improved independence in activities of daily living; improved cognition; improved emotive state; reduction in perceived upper body pain.

Another component of the research project is a small pilot targeting individuals with Parkinson's disease. For them the project is going to:

determine technology acceptance when using the BrightBrainer system; benefit to arms motor function and strengthening when playing BCI therapeutic games; benefit to reduction or tremor when playing games; cognitive benefits improvement in their well-being.

Eligibility criteria: Inclusion Criteria (general)

* 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.

* Inclusion Criterion for the controlled clinical trials arm at Kessler Foundation

  • Living within 25 miles radius of Kessler Foundation West Orange location. This will facilitate participation in the outpatient clinic training, which follows inpatient rehabilitation.
* Exclusion Criteria. (general)

  * 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.
  * paranoia and psychotic behaviour.
  * inability participate in the neuropsychological pre-study assessment for reliable scores (e.g., cognitive impairment, communication disorders).

Exclusion Criteria. (Controlled study arm)

o Those living outside approximately 25 miles radius of Kessler Foundation West Orange location. Those living too far will have a harder time completing the study as outpatients, as they will probably choose clinics closer to home.

Primary outcomes:
measure: Change in Fugl-Meyer Assessment score for upper extremity function (UE sub-set)
timeFrame: Change between baseline, at 3 weeks and at 5 weeks post enrollment
measure: Change in Cognitive executive function assessment score
timeFrame: Change between baseline, at 3 weeks and at 5 weeks post enrollment
Secondary outcomes:
measure: Change in Arm Range of Motion
timeFrame: Change between baseline, at 3 weeks and at 5 weeks post enrollment
measure: Change in Grasp strength for whole hand (power grasp) and finger pinch
timeFrame: Change between baseline, at 3 weeks and at 5 weeks post enrollment
measure: Change in Finger Range of Motion measured with mechanical goniometer
timeFrame: Change between baseline, at 3 weeks and at 5 weeks post enrollment
measure: Change in Upper extremity functional index (UEFI-20) of independence in activities of daily living
timeFrame: Change between baseline, at 3 weeks and at 5 weeks post enrollment
measure: Change in Stroke Impact Scale (SIS) measuring impact of stroke on independence in daily activities
timeFrame: Change between baseline, at 3 weeks and at 5 weeks post enrollment
measure: Change in CAHAI 9 Score of independence in bimanual ADLs
timeFrame: Change between baseline, at 3 weeks and at 5 weeks post enrollment
measure: Game % Score (baseline and performance) in therapeutic games
timeFrame: through study completion, an average 5 weeks from enrollment
measure: Game difficulty levels
timeFrame: through study completion, an average 5 weeks from enrollment
measure: Average game difficulty levels per session
timeFrame: through study completion, an average 5 weeks from enrollment
measure: Participants' feedback through subjective evaluation of the system
timeFrame: at 3 weeks and at 5 weeks post enrollment
measure: Change in Verbal attention as measured by the Neuropsychological Assessment Battery
timeFrame: Change between baseline, at 3 weeks and at 5 weeks post enrollment
measure: Change in visual attention as measured by Neuropsychological Assessment Battery
timeFrame: Change between baseline, at 3 weeks and at 5 weeks post enrollment
measure: Change in Beck Depression Inventory II (BDI II) score, a measure of depression severity
timeFrame: Change between baseline, at 3 weeks and at 5 weeks post enrollment
measure: Caregiver evaluation of experimental system
timeFrame: at 5 weeks from enrolment
Other outcomes:
measure: Change in Verbal memory as measured by Hopkins Verbal Learning Test, Revised
timeFrame: Change between baseline, at 3 weeks and at 5 weeks post enrollment
measure: Change in visuospatial memory as measured by Brief Visuospatial Memory Test, Revised (BVMT-R)
timeFrame: Change between baseline, at 3 weeks and at 5 weeks post enrollment
measure: Change in cognitive function as measured by the Montreal Cognitive Assessment Test score
timeFrame: Change between baseline, at 3 weeks and at 5 weeks post enrollment
measure: Change in score for Boston Naming Test of naming objects
timeFrame: Change between baseline, at 3 weeks and at 5 weeks post enrollment
measure: Blood pressure measured with medical meter
timeFrame: through study completion, an average 5 weeks from enrollment
measure: Heart rate measured with medical meter
timeFrame: through study completion, an average 5 weeks from enrollment
Locations:
city: North Brunswick
country: United States
facility: Bright Cloud Int'l Corp
state: New Jersey
city: West Orange
country: United States
facility: Kessler Foundation
state: New Jersey
Study officials:
affiliation: Bright Cloud International Corp
name: Grigore C Burdea, PhD
role: STUDY_DIRECTOR
References: