Rehab CARES In USA: Clinical Trial

Stroke Clinical Trial

Official title:

Rehabilitation Using Community-Based Affordable Robotic Exercise Systems (Rehab CARES)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05542121
• Other study ID #: 853607
• Secondary ID: R42HD104325
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: August 30, 2024

Study information

• Verified date: June 2023
• Source: University of Pennsylvania
• Contact: Pamela Z Cacchione, PhD, RN
• Phone: 215-259-0428
• Email: pamelaca[@]nursing.upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In Phase 2, Patients in a community-based setting who have had a stroke will be evaluated by rehabilitation professionals and asked to perform a battery of clinical assessments before and after standard of care and robot assisted therapy with Rehab CARES system of simple force-feedback robots that are adapted to deliver single and group therapy.

Description:

In Phase 2, we will develop the hardware to allow three haptic robots to dock (a gym) and be configured to allow patients to play therapy games alone or collaboratively. We will test the safety and feasibility of the gym in a community-based rehabilitation setting. We will treat 36 patients randomized to either a control group getting standard of care therapy and a robot group receiving standard of care with upper limb therapy being given using the robot gym instead of an occupational therapist. Therapy will occur over 4 weeks with two follow-up assessments. Key milestones will be to show that the robot group has the same or better functional outcomes, motivation, and adverse events as the control group. Also to show that the robot gym is a cost-effective solution to increasing access to quality rehabilitation care in low-resource, community-based settings. Success here will validate this potential solution, justify design changes revealed via user-feedback and a larger clinical trial.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: August 30, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

• Age 55 and older (based on who is admitted to the CBR site)

• >3 months post-stroke

• Stroke diagnosis

• Diagnosis of hemiparesis as a result of stroke (verified by radiology data)

• Motor control score on Upper Extremity Fugl-Meyer scale > 15 and < 60;

• Able to understand and speak

• Upper arm manual muscle strength scores >1

• Pain Scores < 8 based on NIH Pain Intensity Scale

Exclusion Criteria:

• no cerebellum lesions due to stroke

• severe cognitive function

Related Conditions & MeSH terms

• Hemiplegia
• Stroke

Intervention

Device:
• Robot-Assisted Therapy with Rehab CARES system
60 min sessions; 3 sessions per week; for 4 weeks; Patients uses 1 or more affordable robots to exercise the UL with adaptive games assessments as OT; standard of care PT and SLP; Subjects' motor and cognitive impairment will be used to set the game and modes. The game parameters will be adjusted according to motor and cognitive impairment of that station's user while the controller will automatically adjust assisting or resisting torques experienced. The 60 minutes will be broken up into 15-minute training intervals.

Other:
• Standard of Care
60 min sessions; 3 sessions per week; for 4 weeks of OT, PT, and SLP

Locations

Country	Name	City	State
United States	Mercy Living Independently for Elders (L.I.F.E) - West Philadelphia	Philadelphia	Pennsylvania
United States	Penn Medicine Rittenhouse	Philadelphia	Pennsylvania

Sponsors (5)

Lead Sponsor	Collaborator
University of Pennsylvania	enAble Games LLC, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Mercy Living Independently for Elders (LIFE) - West Philadelphia (Trinity Health Pace), Recupero Robotics LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Motor Control	Measured by Change in Upper Extremity Fugl-Meyer Assessment (UE-FM); scale is out of 66. A lower score means more impaired.	After 12 sessions (post-pre), after follow-up at 4 weeks (post-follow-up)
Primary	Change in Gross Hand Function	Measured by Changes in Box and Block (BnB) Test; metric # of blocks transferred. A higher score means less impaired.	After 12 sessions (post-pre), after follow-up at 4 weeks (post-follow-up)
Primary	Change in Hand Dexterity	Measured by changes in NIH Toolbox 9-Hole Pegboard Dexterity Test; metric time and # of peg transferred over time. A higher number of pegs means less impaired.	After 12 sessions (post-pre), after follow-up at 4 weeks (post-follow-up)
Primary	Upper Extremity Function	Measured by changes in the Neuro-QoL: Upper Extremity Function - Fine Motor, ADL Short Form. Short form is a self-report on 8 items to assesses fine motor function and activity of daily living in upper arm.	at pre, at post-intervention (after 12 sessions), at follow-up
Primary	Quality of life (Participation)	Measured by changes in the Neuro-QoL: Ability to Participate in Social Role and Activities Short Form.	at pre, at post-intervention (after 12 sessions), at follow-up
Primary	Quality of life (Satisfaction)	Measured by changes in Neuro-QoL Satisfaction with Social Roles and Activities Short Form.	at pre, at post-intervention (after 12 sessions), at follow-up
Primary	Motivation	Measured by the Self-Assessment Manikin (SAM) scale which consist of 3 subscales: enjoyment, engagement, and control. Each subscale is from 0 to 9. For enjoyment and engagement the higher score is the better and for control the lower score is better.	at pre, at post-intervention (after 12 sessions), at follow-up
Secondary	Change in Cognition	Measured by changes in Montreal Cognitive Assessment (MocA)	After 12 sessions (post-pre), after follow-up at 4 weeks (post-follow-up)
Secondary	Visual Spatial Attention	Measured by changes in Color Trails 1.A timed trail making assessment. A faster time result is better. Timed results are normalized by age and education and reported as a normalized z-score.	at pre, at post-intervention (after 12 sessions), at follow-up
Secondary	Executive Function	Measured by performance on Color Trails 2. A timed trail making assessment. A lower time is better. Timed results are normalized by age and education and reported as a normalized z-score.	at pre, at post-intervention (after 12 sessions), at follow-up
Secondary	Active Joint Range of Motion (ROM)	Range of Motion joint testing of the upper limb. Subjects shoulder, elbow, and wrist joint active joint movements are evaluated in the impaired arm. Reported in degrees.	at pre, at post-intervention (after 12 sessions), at follow-up
Secondary	Passive Joint Range of Motion (ROM)	Range of Motion joint testing of the upper limb. Subjects shoulder, elbow, and wrist joint passive joint movements are evaluated in the impaired arm. Reported in degrees.	at pre, at post-intervention (after 12 sessions), at follow-up
Secondary	Grip Strength	Measured by NIH toolbox Grip Strength Test. The amount of pound-force is measured. The higher pound-force is better.	at pre, at post-intervention (after 12 sessions), at follow-up
Secondary	Exertion Level	Measured by score on Borg Exertion Scale. Score is from 0 to 10. 0 is low and 10 is max. Subjects are asked to report pain experienced during a 60 minute session. Exertion between 0 and 6 is expected.	at each of 12 therapy sessions
Secondary	Pain Level	Measured by score on Visual Analog Pain Scale. Patients indicate a pain score is from 0 to 10. 0 is low and 10 is max. Subjects are asked to report pain experienced during a 60 minute session. Pain < 4 is expected.	at each of 12 therapy sessions
Secondary	Usability	Measured by score on System Usability Scale. Score is from 0 to 100. 0 is low and 100 is max. A score greater than or equal to 68 is ideal.	at pre, at post-intervention (after 12 sessions), at follow-up
Secondary	Work Load	Measured by NASA TLX Task Demand Scale. The scale consist of 6 questions scored on a likert scale of 0 to 21. The responses are processed to define a workload score. A workload score at or above 37 which is MOD-HIGH is expected.	at pre, at post-intervention (after 12 sessions), at follow-up
Secondary	Prediction of Motor Function	Measured by R-squared value from regression models of robot metrics from custom assessment tasks with respect to motor measurements of grip strength, gross hand function and fine motor function	at pre, at post-intervention (after 12 sessions), at follow-up
Secondary	Prediction of Cognitive Function	Measured by R-squared value from regression models of robot metrics from custom assessment tasks with respect to cognitive measurements of overall cognition, attention and executive function.	at pre, at post-intervention (after 12 sessions), at follow-up