Use of Repetitive Facilitative Exercise Program in Established Stroke

NCT01574599 | Terminated

• 1 other identifier: 11-005596
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Stroke; weakness; rehabilitation; chronic stroke

Outcome Measures

Primary Outcomes (1)

• Fugl-Meyer Arm score

  baseline, immediate post-intervention and 3 month post-intervention

Secondary Outcomes (6)

• Motor Activity Log

  baseline, immediate post-intervention and 3 month post-intervention

• 9-Hole Peg Test

  baseline, immediate post-intervention and 3 month post-intervention

• Box and Block test

  baseline, immediate post-intervention and 3 month post-intervention

• Grasp strength

  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

Study Arms (2)

Repetitive Facilitative Exercise

EXPERIMENTAL

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.

Other: Occupational therapy- Repetitive Facilitative Exercise

Conventional Therapy Program

NO INTERVENTION

Typical therapy excluding robotics, RFE

Interventions

Occupational therapy- Repetitive Facilitative Exercise 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.

Repetitive Facilitative Exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Stroke; Asthenia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Billie Schultz, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD; Consultant in Department of Physical Medicine and Rehabilitation

Study Record Dates

• First Submitted: April 6, 2012
• First Posted: April 10, 2012
• Study Start: April 1, 2012
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: March 22, 2017

Record last verified: 2017-03

Locations

US (1)