NCT03503617

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 11, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 20, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
10 months until next milestone

Results Posted

Study results publicly available

February 7, 2022

Completed
Last Updated

February 7, 2022

Status Verified

January 1, 2022

Enrollment Period

2.4 years

First QC Date

April 11, 2018

Results QC Date

November 15, 2021

Last Update Submit

January 10, 2022

Conditions

Cerebral Stroke

Outcome Measures

Primary Outcomes (1)

  • Change in Fugl-Meyer Arm Motor Score From Baseline to One Month Post Therapy

    The Fugl-Meyer Arm Motor Score is a stroke-specific, performance-based impairment index which measure 33 arm movement patterns based on a scale of 0 to 2 each, for a total possible score of 66. For each movement patter, a score of zero means the participant is unable to perform the movement pattern; a score of 2 means the participant performed the movement patterns faultlessly.

    From Baseline to One-month Post-therapy

Secondary Outcomes (5)

  • Change in Box and Blocks Test Score

    From Baseline to One-month Post-therapy

  • 10 Meter Walk Test

    From Baseline to One-month Post-therapy

  • Motor Activity Log

    One-month Post-therapy

  • Visual Analog Pain Scale

    From Baseline to One-month Post-therapy

  • Modified Ashworth Spasticity Scale

    From Baseline to One-month Post-therapy

Study Arms (2)

RehabTouch Exercise Program

EXPERIMENTAL

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.

Device: RehabTouch

Conventional tabletop exercise program

ACTIVE COMPARATOR

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.

Other: Conventional tabletop exercise program

Interventions

RehabTouchDEVICE

Exercise using the motion sensing devices and a computer

Also known as: FitMi
RehabTouch Exercise Program
Conventional tabletop exercise programOTHER

Exercise following printed sheets of exercises

Conventional tabletop exercise program

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Concurrent severe medical problems, visual deficits, severe neglect or apraxia
  • Enrollment to other therapy studies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rancho Research Institute, Inc.

Downey, California, 90242, United States

Location

Related Publications (1)

  • 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.

    PMID: 36636751DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Results Point of Contact

Title
Daniel Zondervan
Organization
Flint Rehabilitation Devices
dzondervan@flintrehab.com
9493137322

Study Officials

  • Susan Shaw, MD

    Rancho Research Institute, Inc.

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice President

Study Record Dates

First Submitted

April 11, 2018

First Posted

April 20, 2018

Study Start

November 1, 2018

Primary Completion

March 31, 2021

Study Completion

March 31, 2021

Last Updated

February 7, 2022

Results First Posted

February 7, 2022

Record last verified: 2022-01

Locations

US(1)