Use of Repetitive Facilitative Exercise Program in Established Stroke
Primary Purpose
Stroke
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Occupational therapy- Repetitive Facilitative Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Stroke, weakness, rehabilitation, chronic stroke
Eligibility 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
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Repetitive Facilitative Exercise
Conventional Therapy Program
Arm Description
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.
Typical therapy excluding robotics, RFE
Outcomes
Primary Outcome Measures
Fugl-Meyer Arm score
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01574599
Brief Title
Use of Repetitive Facilitative Exercise Program in Established Stroke
Official Title
A Randomized Controlled Evaluation of a Repetitive Facilitative Exercise Program for Adults With an Established Stroke and Upper Extremity Impairment
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Terminated
Why Stopped
poor subject recruitment
Study Start Date
April 2012 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, weakness, rehabilitation, chronic stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Repetitive Facilitative Exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional Therapy Program
Arm Type
No Intervention
Arm Description
Typical therapy excluding robotics, RFE
Intervention Type
Other
Intervention Name(s)
Occupational therapy- Repetitive Facilitative Exercise
Intervention Description
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 Measure Information:
Title
Fugl-Meyer Arm score
Time Frame
baseline, immediate post-intervention and 3 month post-intervention
Secondary Outcome Measure Information:
Title
Motor Activity Log
Time Frame
baseline, immediate post-intervention and 3 month post-intervention
Title
9-Hole Peg Test
Time Frame
baseline, immediate post-intervention and 3 month post-intervention
Title
Box and Block test
Time Frame
baseline, immediate post-intervention and 3 month post-intervention
Title
Grasp strength
Time Frame
baseline, immediate post-intervention and 3 month post-intervention
Title
Active Range of motion of shoulder flexion, wrist extension, and index finger extension
Time Frame
baseline, immediate post-intervention and 3 month post-intervention
Title
Overall patient satisfaction
Time Frame
baseline, immediate post-intervention and 3 month post-intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Billie Schultz, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
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Use of Repetitive Facilitative Exercise Program in Established Stroke
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