Use of Repetitive Facilitative Exercise Program in Established Stroke

March 21, 2017 updated by: Billie A. Schultz, Mayo Clinic

A Randomized Controlled Evaluation of a Repetitive Facilitative Exercise Program for Adults With an Established Stroke and Upper Extremity Impairment

The purpose of this study is to assess whether a novel therapy approach (repetitive facilitative exercise (RFE)) is more effective than conventional rehabilitation in facilitating the recovery of upper extremity function following stroke.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age greater than 18 years
  • Having a single ischemic or hemorrhagic hemispheric stroke of more than 6 months duration
  • The ability to selectively demonstrate active extension of at least 10 degrees at the metacarpo-phalangeal joint and the interphalangeal joints and 20 degrees at the wrist
  • Capable of effectively participating in the study

Exclusion Criteria:

  • Upper extremity contracture/pain that interfere with study technique
  • Pre-existing upper extremity neurologic or orthopedic disorders
  • Unstable medical condition
  • BMI > 35
  • Active treatment of condition during 3 months prior to enrollment in study (botulinum toxin, therapy, tendon release, etc.)
  • Language or cognitive/perceptual deficits or scheduling problems that would limit participation
  • Inability to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Repetitive Facilitative Exercise
Occupational therapy program - Repetitive facilitative exercise therapy protocol including 40 min of RFE and 20 minutes of task-specific activity. 3 treatment sessions weekly for a total of 4 weeks.
Other: Occupational therapy- Repetitive Facilitative Exercise
Occupational therapy program - Repetitive facilitative exercise therapy protocol including 40 min of RFE and 20 minutes of task-specific activity. 3 treatment sessions weekly for a total of 4 weeks.
No Intervention: Conventional Therapy Program
Typical therapy excluding robotics, RFE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fugl-Meyer Arm score
Time Frame: baseline, immediate post-intervention and 3 month post-intervention
baseline, immediate post-intervention and 3 month post-intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
Motor Activity Log
Time Frame: baseline, immediate post-intervention and 3 month post-intervention
baseline, immediate post-intervention and 3 month post-intervention
9-Hole Peg Test
Time Frame: baseline, immediate post-intervention and 3 month post-intervention
baseline, immediate post-intervention and 3 month post-intervention
Box and Block test
Time Frame: baseline, immediate post-intervention and 3 month post-intervention
baseline, immediate post-intervention and 3 month post-intervention
Grasp strength
Time Frame: baseline, immediate post-intervention and 3 month post-intervention
baseline, immediate post-intervention and 3 month post-intervention
Active Range of motion of shoulder flexion, wrist extension, and index finger extension
Time Frame: baseline, immediate post-intervention and 3 month post-intervention
baseline, immediate post-intervention and 3 month post-intervention
Overall patient satisfaction
Time Frame: baseline, immediate post-intervention and 3 month post-intervention
baseline, immediate post-intervention and 3 month post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Billie Schultz, MD, Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

April 6, 2012

First Submitted That Met QC Criteria

April 9, 2012

First Posted (Estimate)

April 10, 2012

Study Record Updates

Last Update Posted (Actual)

March 22, 2017

Last Update Submitted That Met QC Criteria

March 21, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-005596

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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