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

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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

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
United States, Minnesota | |
Mayo Clinic in Rochester | |
Rochester, Minnesota, United States, 55905 |
Principal Investigator: | Billie Schultz, MD | Mayo Clinic |
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 |
Stroke weakness rehabilitation chronic stroke |
Stroke Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases |