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Use of Repetitive Facilitative Exercise Program in Established Stroke

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ClinicalTrials.gov Identifier: NCT01574599
Recruitment Status : Terminated (poor subject recruitment)
First Posted : April 10, 2012
Last Update Posted : March 22, 2017
Sponsor:
Information provided by (Responsible Party):
Billie A. Schultz, Mayo Clinic

Tracking Information
First Submitted Date  ICMJE April 6, 2012
First Posted Date  ICMJE April 10, 2012
Last Update Posted Date March 22, 2017
Study Start Date  ICMJE April 2012
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 26, 2013)
Fugl-Meyer Arm score [ Time Frame: baseline, immediate post-intervention and 3 month post-intervention ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 9, 2012)
Fugl-Meyer Arm score
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 26, 2013)
  • Motor Activity Log [ Time Frame: baseline, immediate post-intervention and 3 month post-intervention ]
  • 9-Hole Peg Test [ Time Frame: baseline, immediate post-intervention and 3 month post-intervention ]
  • Box and Block test [ Time Frame: baseline, immediate post-intervention and 3 month post-intervention ]
  • Grasp strength [ Time Frame: 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 ]
  • Overall patient satisfaction [ Time Frame: baseline, immediate post-intervention and 3 month post-intervention ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 9, 2012)
  • Motor Activity Log
  • 9-Hole Peg Test
  • Box and Block test
  • Grasp strength
  • Active Range of motion of shoulder flexion, wrist extension, and index finger extension
  • Overall patient satisfaction
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Use of Repetitive Facilitative Exercise Program in Established Stroke
Official Title  ICMJE A Randomized Controlled Evaluation of a Repetitive Facilitative Exercise Program for Adults With an Established Stroke and Upper Extremity Impairment
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Stroke
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Other: Occupational therapy- Repetitive Facilitative Exercise
  • No Intervention: Conventional Therapy Program
    Typical therapy excluding robotics, RFE
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 21, 2017)
15
Original Estimated Enrollment  ICMJE
 (submitted: April 9, 2012)
40
Actual Study Completion Date  ICMJE October 2016
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01574599
Other Study ID Numbers  ICMJE 11-005596
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Billie A. Schultz, Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Billie Schultz, MD Mayo Clinic
PRS Account Mayo Clinic
Verification Date March 2017

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