Rehab CARES In USA: Clinical Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2025-08-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Stroke Hemiplegia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Standard of Care

60 min OT sessions; 3 sessions per week; for 4 weeks;-- augmented Standard therapy - consisting of PT, OT and SLP. Clinical Assessment (B1-pre, B2-post, B3-follow-up#1, B4-follow-up#2).

Group Type PLACEBO_COMPARATOR

Standard of Care

Intervention Type OTHER

60 min sessions; 3 sessions per week; for 4 weeks of OT, PT, and SLP

Robot-Assisted Therapy with Rehab CARES system

60 min sessions; 3 sessions per week; for 4 weeks;----of Upper Limb therapy using 1 or more affordable robots. Robot sessions can be group play and/or single play.

Robot Assessment (B1-pre, B2-post, B3-follow-up#1, B4-follow-up#2)

Group Type EXPERIMENTAL

Robot-Assisted Therapy with Rehab CARES system

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Standard of Care

60 min sessions; 3 sessions per week; for 4 weeks of OT, PT, and SLP

Intervention Type OTHER

Eligibility Criteria

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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