RehabTouch Home Therapy for Stroke Patients

NCT ID: NCT03503617

Last Updated: 2022-02-07

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-01

Study Completion Date

2021-03-31

Brief Summary

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We will investigate the efficacy of a newly developed exercise device (RehabTouch) for people in the subacute stage after a stroke compared to a traditional tabletop exercise program. RehabTouch uses embedded sensors that can track and record the patient's direction and degree of movement as they perform exercises described on a computer.

Detailed Description

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Conditions

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Cerebral Stroke

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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RehabTouch Exercise Program

Participants will perform targetted movement exercises by interacting with the RehabTouch pucks, as described and monitored on a computer. Participants will be asked to exercise at least 3 hours per week for 3 consecutive weeks.

Group Type EXPERIMENTAL

RehabTouch

Intervention Type DEVICE

Exercise using the motion sensing devices and a computer

Conventional tabletop exercise program

Conventional tabletop exercise program is a traditional exercise program described in a booklet similar to what is typical provided to stroke patients upon their discharge from the hospital. Participants will be asked to perform these exercises at least 3 hours per week for 3 consecutive weeks.

Group Type ACTIVE_COMPARATOR

Conventional tabletop exercise program

Intervention Type OTHER

Exercise following printed sheets of exercises

Interventions

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RehabTouch

Exercise using the motion sensing devices and a computer

Intervention Type DEVICE

Conventional tabletop exercise program

Exercise following printed sheets of exercises

Intervention Type OTHER

Other Intervention Names

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FitMi

Eligibility Criteria

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Inclusion Criteria

* Age: 18 to 85 years old
* Upper extremity weakness measured by a clinical scale
* Absence of moderate to severe pain on affected upper extremity
* Able to understand the instructions to operate RehabTouch

Exclusion Criteria

* Concurrent severe medical problems, visual deficits, severe neglect or apraxia
* Enrollment to other therapy studies
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rancho Research Institute, Inc.

OTHER

Sponsor Role collaborator

Flint Rehabilitation Devices, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Flint Rehabilitation Devices, LLC

Vice President

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Susan Shaw, MD

Role: PRINCIPAL_INVESTIGATOR

Rancho Research Institute, Inc.

Locations

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Rancho Research Institute, Inc.

Downey, California, United States

Site Status

Countries

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United States

References

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Swanson VA, Johnson C, Zondervan DK, Bayus N, McCoy P, Ng YFJ, Schindele Bs J, Reinkensmeyer DJ, Shaw S. Optimized Home Rehabilitation Technology Reduces Upper Extremity Impairment Compared to a Conventional Home Exercise Program: A Randomized, Controlled, Single-Blind Trial in Subacute Stroke. Neurorehabil Neural Repair. 2023 Jan;37(1):53-65. doi: 10.1177/15459683221146995. Epub 2023 Jan 12.

Reference Type DERIVED
PMID: 36636751 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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1R44AG059256-01A1

Identifier Type: NIH

Identifier Source: org_study_id

View Link

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