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Training the Arm and Hand After Stroke Using Auditory Rhythm Cues

Primary Purpose

Stroke, Hemiplegia

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Constraint-Induced Movement Therapy + auditory rhythm cues
Constraint-Induced Movement Therapy
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Rehabilitation, hemiplegia, stroke, upper extremity, motor skills, therapy

Eligibility Criteria

21 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • single ischemic stroke at least 3 months prior
  • no active drug or alcohol abuse
  • able to follow 2-step commands
  • no history of more than minor head trauma, subarachnoid hemorrhage, dementia, drug or alcohol abuse, schizophrenia, serious medical illness, or refractory depression
  • able to elevate UE in scapular plane (combination of flexion and abduction)at least 300 with at least 450 active elbow extension available during this movement and able to extend the wrist 200 and 2 fingers and the thumb 100 three times in a minute.

Exclusion Criteria:

  • no movement in UE or no active 200 of wrist extension and no active 100 of thumb and finger extension three times in a minute
  • spasticity greater than 2 on the Modified Ashworth Scale
  • scores >3 on Motor Activity Log82 indicating poor use of UE
  • able to complete shoulder flexion and abduction to shoulder height easily (e.g., doesn't hold breath, movement is fluid, little to no effort tremor observed) with elbow straight and able to complete checkers item on the WMFT9 within 16 seconds
  • greater than mild hearing loss per audiogram.

Sites / Locations

  • North Florida/South Georgia Veterans Health System - Malcom Randall VAMC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A

F

Arm Description

This group will complete a 2 week program of functional task practice with auditory rhythm cuing.

This group will complete a 2 week program of functional task practice without auditory rhythm cuing.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 29, 2007
Last Updated
February 3, 2012
Sponsor
University of Florida
Collaborators
National Institutes of Health (NIH), US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00523523
Brief Title
Training the Arm and Hand After Stroke Using Auditory Rhythm Cues
Official Title
Auditory Rhythm Cues + Task Practice: Effects on UE Motor Function Post-stroke
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
National Institutes of Health (NIH), US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine whether or not having people with stroke practice performing tasks to auditory rhythm cues with their weaker arm and hand is any better at promoting improved motor control than practicing the tasks in a typical way without the rhythm cues
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Hemiplegia
Keywords
Rehabilitation, hemiplegia, stroke, upper extremity, motor skills, therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
This group will complete a 2 week program of functional task practice with auditory rhythm cuing.
Arm Title
F
Arm Type
Active Comparator
Arm Description
This group will complete a 2 week program of functional task practice without auditory rhythm cuing.
Intervention Type
Behavioral
Intervention Name(s)
Constraint-Induced Movement Therapy + auditory rhythm cues
Other Intervention Name(s)
Functional task practice, Forced use
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Constraint-Induced Movement Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: single ischemic stroke at least 3 months prior no active drug or alcohol abuse able to follow 2-step commands no history of more than minor head trauma, subarachnoid hemorrhage, dementia, drug or alcohol abuse, schizophrenia, serious medical illness, or refractory depression able to elevate UE in scapular plane (combination of flexion and abduction)at least 300 with at least 450 active elbow extension available during this movement and able to extend the wrist 200 and 2 fingers and the thumb 100 three times in a minute. Exclusion Criteria: no movement in UE or no active 200 of wrist extension and no active 100 of thumb and finger extension three times in a minute spasticity greater than 2 on the Modified Ashworth Scale scores >3 on Motor Activity Log82 indicating poor use of UE able to complete shoulder flexion and abduction to shoulder height easily (e.g., doesn't hold breath, movement is fluid, little to no effort tremor observed) with elbow straight and able to complete checkers item on the WMFT9 within 16 seconds greater than mild hearing loss per audiogram.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lorie G Richards, PhD
Organizational Affiliation
University of Florida and North Florida/South Georgia Veterans Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
North Florida/South Georgia Veterans Health System - Malcom Randall VAMC
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11900758
Citation
Thaut MH, Kenyon GP, Hurt CP, McIntosh GC, Hoemberg V. Kinematic optimization of spatiotemporal patterns in paretic arm training with stroke patients. Neuropsychologia. 2002;40(7):1073-81. doi: 10.1016/s0028-3932(01)00141-5.
Results Reference
background
PubMed Identifier
17077374
Citation
Wolf SL, Winstein CJ, Miller JP, Taub E, Uswatte G, Morris D, Giuliani C, Light KE, Nichols-Larsen D; EXCITE Investigators. Effect of constraint-induced movement therapy on upper extremity function 3 to 9 months after stroke: the EXCITE randomized clinical trial. JAMA. 2006 Nov 1;296(17):2095-104. doi: 10.1001/jama.296.17.2095.
Results Reference
background

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Training the Arm and Hand After Stroke Using Auditory Rhythm Cues

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