Text Size

Use of Repetitive Facilitative Exercise Program in Established Stroke

This study is currently recruiting participants.
Verified February 2013 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Billie A. Schultz, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01574599
First received: April 6, 2012
Last updated: February 26, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention
Stroke
 Other: Occupational therapy- Repetitive Facilitative Exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Evaluation of a Repetitive Facilitative Exercise Program for Adults With an Established Stroke and Upper Extremity Impairment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Fugl-Meyer Arm score [ Time Frame: baseline, immediate post-intervention and 3 month post-intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Motor Activity Log [ Time Frame: baseline, immediate post-intervention and 3 month post-intervention ] [ Designated as safety issue: No ]
  • 9-Hole Peg Test [ Time Frame: baseline, immediate post-intervention and 3 month post-intervention ] [ Designated as safety issue: No ]
  • Box and Block test [ Time Frame: baseline, immediate post-intervention and 3 month post-intervention ] [ Designated as safety issue: No ]
  • Grasp strength [ Time Frame: baseline, immediate post-intervention and 3 month post-intervention ] [ Designated as safety issue: No ]
  • Active Range of motion of shoulder flexion, wrist extension, and index finger extension [ Time Frame: baseline, immediate post-intervention and 3 month post-intervention ] [ Designated as safety issue: No ]
  • Overall patient satisfaction [ Time Frame: baseline, immediate post-intervention and 3 month post-intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: April 2012
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Repetitive Facilitative Exercise
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
No Intervention: Conventional Therapy Program

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01574599

Locations
United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Billie A Schultz, MD     507-255-3166     schultz.billie@mayo.edu    
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Billie Schultz, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Billie A. Schultz, MD; Senior Associate Consultant in Department of Physical Medicine and Rehabilitation, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01574599     History of Changes
Other Study ID Numbers: 11-005596
Study First Received: April 6, 2012
Last Updated: February 26, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Stroke
weakness
rehabilitation
Stroke greater than 6 months prior with associated upper extremity impairment

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on May 16, 2013