Use of Repetitive Facilitative Exercise Program in Established Stroke

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 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: August 14, 2014
Last verified: August 2014

April 6, 2012
August 14, 2014
April 2012
April 2015   (final data collection date for primary outcome measure)
Fugl-Meyer Arm score [ Time Frame: baseline, immediate post-intervention and 3 month post-intervention ] [ Designated as safety issue: No ]
Fugl-Meyer Arm score [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01574599 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Motor Activity Log [ Designated as safety issue: No ]
  • 9-Hole Peg Test [ Designated as safety issue: No ]
  • Box and Block test [ Designated as safety issue: No ]
  • Grasp strength [ Designated as safety issue: No ]
  • Active Range of motion of shoulder flexion, wrist extension, and index finger extension [ Designated as safety issue: No ]
  • Overall patient satisfaction [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Use of Repetitive Facilitative Exercise Program in Established Stroke
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Stroke
Other: Occupational therapy- Repetitive Facilitative Exercise
  • 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.
    Intervention: Other: Occupational therapy- Repetitive Facilitative Exercise
  • No Intervention: Conventional Therapy Program
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
Not Provided
April 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
United States
 
NCT01574599
11-005596
No
Billie A. Schultz, Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: Billie Schultz, MD Mayo Clinic
Mayo Clinic
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP