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Use of Repetitive Facilitative Exercise Program in Established Stroke

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01574599
Enrollment
15
Registered
2012-04-10
Start date
2012-04-30
Completion date
2016-10-31
Last updated
2017-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

Stroke, weakness, rehabilitation, chronic stroke

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.

Interventions

OTHEROccupational 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.

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Fugl-Meyer Arm scorebaseline, immediate post-intervention and 3 month post-intervention

Secondary

MeasureTime frame
9-Hole Peg Testbaseline, immediate post-intervention and 3 month post-intervention
Box and Block testbaseline, immediate post-intervention and 3 month post-intervention
Motor Activity Logbaseline, immediate post-intervention and 3 month post-intervention
Active Range of motion of shoulder flexion, wrist extension, and index finger extensionbaseline, immediate post-intervention and 3 month post-intervention
Overall patient satisfactionbaseline, immediate post-intervention and 3 month post-intervention
Grasp strengthbaseline, immediate post-intervention and 3 month post-intervention

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026