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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Stroke Other: Occupational therapy- Repetitive Facilitative Exercise Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (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
Study Start Date : April 2012
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Fugl-Meyer Arm score [ Time Frame: baseline, immediate post-intervention and 3 month post-intervention ]

Secondary Outcome Measures :
  1. Motor Activity Log [ Time Frame: baseline, immediate post-intervention and 3 month post-intervention ]
  2. 9-Hole Peg Test [ Time Frame: baseline, immediate post-intervention and 3 month post-intervention ]
  3. Box and Block test [ Time Frame: baseline, immediate post-intervention and 3 month post-intervention ]
  4. Grasp strength [ Time Frame: baseline, immediate post-intervention and 3 month post-intervention ]
  5. Active Range of motion of shoulder flexion, wrist extension, and index finger extension [ Time Frame: baseline, immediate post-intervention and 3 month post-intervention ]
  6. Overall patient satisfaction [ Time Frame: baseline, immediate post-intervention and 3 month post-intervention ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01574599


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Billie Schultz, MD Mayo Clinic
More Information
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Responsible Party: Billie A. Schultz, MD; Consultant in Department of Physical Medicine and Rehabilitation, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01574599    
Other Study ID Numbers: 11-005596
First Posted: April 10, 2012    Key Record Dates
Last Update Posted: March 22, 2017
Last Verified: March 2017
Keywords provided by Billie A. Schultz, Mayo Clinic:
Stroke
weakness
rehabilitation
chronic stroke
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases