Use of Repetitive Facilitative Exercise Program in Established Stroke

Stroke Clinical Trial

Official title:

A Randomized Controlled Evaluation of a Repetitive Facilitative Exercise Program for Adults With an Established Stroke and Upper Extremity Impairment

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01574599
• Other study ID #: 11-005596
• Status: Terminated
• Phase: N/A
• First received: April 6, 2012
• Last updated: March 21, 2017
• Start date: April 2012
• Est. completion date: October 2016

Study information

• Verified date: March 2017
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fugl-Meyer Arm score		baseline, immediate post-intervention and 3 month post-intervention
Secondary	Motor Activity Log		baseline, immediate post-intervention and 3 month post-intervention
Secondary	9-Hole Peg Test		baseline, immediate post-intervention and 3 month post-intervention
Secondary	Box and Block test		baseline, immediate post-intervention and 3 month post-intervention
Secondary	Grasp strength		baseline, immediate post-intervention and 3 month post-intervention
Secondary	Active Range of motion of shoulder flexion, wrist extension, and index finger extension		baseline, immediate post-intervention and 3 month post-intervention
Secondary	Overall patient satisfaction		baseline, immediate post-intervention and 3 month post-intervention