Use of Repetitive Facilitative Exercise Program in Established Stroke

NCT ID: NCT01574599

Last Updated: 2017-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2016-10-31

Brief Summary

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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

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Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Occupational therapy- Repetitive Facilitative Exercise

Intervention Type OTHER

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.

Conventional Therapy Program

Typical therapy excluding robotics, RFE

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Billie A. Schultz

MD; Consultant in Department of Physical Medicine and Rehabilitation

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Billie Schultz, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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11-005596

Identifier Type: -

Identifier Source: org_study_id

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