Training the Arm and Hand After Stroke Using Auditory Rhythm Cues
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00523523|
Recruitment Status : Completed
First Posted : August 31, 2007
Last Update Posted : February 6, 2012
|Condition or disease||Intervention/treatment||Phase|
|Stroke Hemiplegia||Behavioral: Constraint-Induced Movement Therapy + auditory rhythm cues Behavioral: Constraint-Induced Movement Therapy||Phase 1 Phase 2|
Stroke is the leading cause of adult-onset disability in the United States, and 75% of those presenting with UE deficits continue to have decreased UE function, despite rehabilitation. Despite demonstrated efficacy that functional task practice promotes improved UE function post-stroke,4-6 most subjects continue to have substantial disability, reporting less paretic hand use than pre-stroke and having lower scores on motor tests. Auditory rhythm entrainment of functional task practice may enhance therapy efficacy by facilitating the adoption of more normal movement patterns. Thus, it is critical to public health that more effective approaches to facilitate UE motor recovery are developed. This study would further the mission of NCMRR to enhance independence of persons with disability and that of NICHD: "optimal well-being of all people through rehabilitation."
The primary aim of this pilot study is to gather preliminary data on the impact of auditory rhythm entrainment of functional task practice (FTARC) on improvement in UE function compared to functional task practice alone (FTP) in subjects with moderate hemiparesis from chronic stroke. Our primary hypothesis is that after FTARC, subjects will demonstrate greater gains in UE function compared to persons in the FTP group. Secondary aims are to understand 1) the relative impact of FTARC on retention of motor skills 6 months after therapy and 2) to understand how changes in more underlying elemental components of UE movement, (kinetic parameters and multi-joint synergies) relate to this improvement in outcome. Our secondary hypotheses are that the subjects with FTARC will demonstrate movement composition that is closer to that of neurologically intact individuals and greater retention of functional gains compared to subjects with FTP.
This study will use a prospective, parallel group design in which subjects, after baseline testing, will be adaptively randomized by UE motor severity into either the FTARC or the FTP groups. Therapy will be 4 hours of task practice per weekday for 2 weeks. Subjects will wear a mitt on their non-paretic hand for 90% of waking hours. Subjects will then complete post-intervention and 6-month follow up testing.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Auditory Rhythm Cues + Task Practice: Effects on UE Motor Function Post-stroke|
|Study Start Date :||August 2007|
|Primary Completion Date :||May 2010|
|Study Completion Date :||June 2010|
This group will complete a 2 week program of functional task practice with auditory rhythm cuing.
Behavioral: Constraint-Induced Movement Therapy + auditory rhythm cues
The intervention is functional task practice with the paretic arm and hand for 4 hours/day for 10 sessions over 2 weeks plus a home program for the intervening weekend. Participants in the experimental group will perform this practice to the beat of a metronome. All participants will also wear a mitt on the less affected hand for up to 90% of waking hours.
Other Name: Functional task practice, Forced use
Active Comparator: F
This group will complete a 2 week program of functional task practice without auditory rhythm cuing.
Behavioral: Constraint-Induced Movement Therapy
The intervention is functional task practice with the paretic arm and hand for 4 hours/day for 10 sessions over 2 weeks plus a home program for the intervening weekend. All participants will also wear a mitt on the less affected hand for up to 90% of waking hours.
- Improved motor control as measured by increased scores on both the upper extremity subtest of the Fugl-Meyer Motor Assessment and the Wolf Motor Function Test [ Time Frame: At 2 weeks, at 3 months, and at 6 months ]
- Improved spatial-temporal movement patterns measured by 3-D motion analysis, improved force control measured by isometric and dynamic force production tasks, and increased paretic arm use measured by increased scores on the Motor Activity Log [ Time Frame: At 2 weeks, 3 months and 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00523523
|United States, Florida|
|North Florida/South Georgia Veterans Health System - Malcom Randall VAMC|
|Gainesville, Florida, United States, 32608|
|Principal Investigator:||Lorie G Richards, PhD||University of Florida and North Florida/South Georgia Veterans Health System|