Arm Motor Rehabilitation, Entertainment and Cognition System for the Elderly

Stroke Clinical Trial

Official title:

Arm Motor Rehabilitation, Entertainment and Cognition System for the Elderly (Feasibility Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04252170
• Other study ID #: BCI-10-001
• Secondary ID: 5R44AG044639-05
• Status: Completed
• Phase: N/A
• Start date: September 15, 2018
• Est. completion date: January 31, 2019

Study information

• Verified date: January 2020
• Source: Bright Cloud International Corp
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The research project is intended to provide information pertaining to the feasibility of the BrightArm Compact robotic rehabilitation system for patients early sub-acute post Cerebral Vascular Accident. The aims are to: a) determine clinical benefit to motor and cognitive function as well as mood; 2) to ascertain technology acceptance by patients and therapists. The experimental training consists of 12 integrative arm/hand and cognitive training by playing therapeutic games. Participants are evaluated pre-and post-intervention and provide subjective evaluation of the system.

Description:

This study targets participants, who had suffered a first stroke recently, and 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) bilateral rehabilitation developed by Bright Cloud International Corp, and if these gains transfer to daily activities.

Specific aims are:

• BAC technology acceptance;

• improvement in motor function for the upper extremity;

• strengthening of shoulder and fingers;

• increased active (self initiated) range of motion for shoulder, arms and fingers;

• improved independence in activities of daily living;

• improvement in cognitive areas of memory, attention and decision making;

• improved mood (as in reduced depression severity);

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: January 31, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

Inclusion Criteria:

• Age 50 to 85;

• diagnosis of first-time CVA that occurred more than 5 days prior and less than 21 days prior

• 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 10 degrees for shoulder and elbow flexion/extension;

• ability to actively extend fingers at least 5 degrees

• cognitive skills to participate (Montreal Cognitive Assessment (MoCA) [Nasreddine et al 2005] score 10-30).

• Subjects may have normal cognition, MCI or dementia

Exclusion Criteria:

• being younger than 50 or older than 85 years of age

• previous stroke

• Stroke that occurred more than 20 days prior to enrollment

• Inability to actively extend fingers at least 5 degrees;

• 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 behavior;

• inability participate in the neuropsychological pre-study assessment for reliable scores (e.g., cognitive impairment, communication disorders).

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Rehabilitation Therapy, Experimental on the BrightArm Compact device
Experimental group will receive VR game-based rehabilitation therapy through Bright Cloud's proprietary device, called BrightArm Compact (BAC). An Occupational Therapist will assist as needed.

Locations

Country	Name	City	State
United States	PowerBack Rehabilitation	Piscataway	New Jersey

Sponsors (3)

Lead Sponsor	Collaborator
Bright Cloud International Corp	Genesis HealthCare System, National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Artificial Intelligence-determined game difficulty level	BrightBrainer game difficulty setting is determined based on patient's past performance, in order to adapt the therapy to a given individual. It representing an average or difficulties of all games played in a session. The measure implies game play intensity and level of challenge	Through study completion, an average of 3 weeks
Primary	Game Score (baseline and performance)	BrightBrainer game baseline and performance scores. Min. score is 0. Max depends on specific game.	Through study completion, an average of 3 weeks
Primary	Participants' feedback using 5-point Likert scale	Subjective evaluation feedback and overall ratings on BrightBrainer games. Consists of multiple questions, each ranked on a 5-point Likert scale, with 1 (min) and 5 (max).	Through study completion, an average of 3 weeks
Primary	Therapist subjective evaluation using 5-point Likert scale	Subjective evaluation given by the attending Occupational Therapist at the end of the experimental intervention. Multiple questions, each ranked from 1 (min) to 5 (max)	3 weeks
Secondary	Arm Range of Motion	measurement of active movement initiated by participant using a mechanical goniometer	Change from Baseline arm range of motion at 3 weeks
Secondary	Finger Range of Motion	finger extension/flexion range using a mechanical goniomter	Change from Baseline finger range of motion at 3 weeks
Secondary	Grasp Strength with Jamar Dynamo-meter	grasp strength measurement using dynamo-meter	Change from Baseline grasp strength at 3 weeks
Secondary	Pinch strength with pinch meter	Pinch strength measured with fingers placed on a pinch meter	Change from Baseline at 3 weeks
Secondary	Shoulder strength	Measurement of shoulder strength using calibrated wrist weights	Change from Baseline shoulder strength at 3 weeks
Secondary	Fugl-Meyer Assessment (Upper Extremity sub-scale) score	Upper Extremity Motor function, score scale is 0 (min) to 66 (max). Larger score means better outcome.	Change from Baseline Fugl-Meyer Assessment Score at 3 weeks
Secondary	Upper extremity functional index (UEFI) score	A self report of independence in 20 activities of daily living (ADLs). Total score range is 0 (min) to 80 (max). Larger score means better outcome.	Change from Baseline Upper Extremity Functional Inex score at 3 weeks
Secondary	CAHAI 9 Score	Chedoke Arm and Hand Activity Inventory, reflecting ADL independence in simulated bimanual activities. Min score 9, max score 63, with larger score meaning better outcomes.	Change from Baseline CAHAI 9 score at 3 weeks
Secondary	Jebsen Test of Hand Function	Timed test of 7 simulated activities of daily living. Lowest score is 0, largest score is 1260. Units are seconds. Lower score means better outcomes (faster completion).	Change from Baseline Jebsen Test of Hand Function score at 3 weeks
Secondary	Beck Depression Inventory II (BDI II) score	participants' depression measure. Range is 0 (min) to 63 (max). Lower score indicate better outcomes (less depression).	Change from Baseline depression severity at 3 weeks
Secondary	Verbal attention	Attention module digit span (working memory) in the Neuropsychological Assessment Battery NAB min 0, larger score is better	Change from Baseline verbal attention at 3 weeks
Secondary	Verbal fluency	verbal fluency test min 0, larger score is better	Change from Baseline verbal fluency at 3 weeks
Secondary	Verbal memory	Hopkins Verbal Learning Test, Revised (HVLT-R) min 0, larger is better	Change from Baseline verbal learning memory at 3 weeks
Secondary	Brief Visuospatial Memory Test-Revised	A measure of memory function min 50 std of 10, larger score is better	Change from Baseline visuospatial memory at 3 weeks
Secondary	Executive Function Module	Word Generation min 0, larger is better	Change from Baseline executive function at 3 weeks
Secondary	Cognitive executive function	Trail Making Test B (TMT-B) lMin 50, std of 10, larger number means better outcomes	Change from Baseline Trail Making Test B (TMT-B) Score at 3 weeks
Secondary	Cognitive executive function	NAB Executive Functioning Module min 50, std is 10, larger number means better outcomes	Change from Baseline NAB Exec Score at 3 weeks
Secondary	Visual attention	Attention module dots (visual) in the Neuropsychological Assessment Battery NAB	Change from Baseline visual attention at 3 weeks

External Links

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