Use of Repetitive Facilitative Exercise Program in Established Stroke

Not Applicable

Terminated

• Conditions: Stroke
• Interventions: Other: Occupational therapy- Repetitive Facilitative Exercise

• Registration Number: NCT01574599
• Lead Sponsor: Mayo Clinic

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 available

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-04-06
• Study First Submitted QC: 2012-04-09
• Study First Posted: 2012-04-10
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-21
• Last Update Posted: 2017-03-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Repetitive Facilitative Exercise	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.

Primary Outcome Measures

Name	Time	Method
Fugl-Meyer Arm score	baseline, immediate post-intervention and 3 month post-intervention

Secondary Outcome Measures

Name	Time	Method
Box and Block test	baseline, immediate post-intervention and 3 month post-intervention
Grasp strength	baseline, immediate post-intervention and 3 month post-intervention
9-Hole Peg Test	baseline, immediate post-intervention and 3 month post-intervention
Active Range of motion of shoulder flexion, wrist extension, and index finger extension	baseline, immediate post-intervention and 3 month post-intervention
Motor Activity Log	baseline, immediate post-intervention and 3 month post-intervention
Overall patient satisfaction	baseline, immediate post-intervention and 3 month post-intervention

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States