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Use of Repetitive Facilitative Exercise Program in Established Stroke

This study has been terminated.
(poor subject recruitment)
Sponsor:
Information provided by (Responsible Party):
Billie A. Schultz, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01574599
First received: April 6, 2012
Last updated: March 21, 2017
Last verified: March 2017
April 6, 2012
March 21, 2017
April 2012
October 2016   (Final data collection date for primary outcome measure)
Fugl-Meyer Arm score [ Time Frame: baseline, immediate post-intervention and 3 month post-intervention ]
Fugl-Meyer Arm score
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 ]
  • 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 ]
  • 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
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
Intervention Model: Crossover Assignment
Masking: Outcomes Assessor
Primary Purpose: Treatment
Stroke
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.
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
15
October 2016
October 2016   (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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01574599
11-005596
No
Not Provided
Not Provided
Not Provided
Billie A. Schultz, Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: Billie Schultz, MD Mayo Clinic
Mayo Clinic
March 2017

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