Training the Arm and Hand After Stroke Using Auditory Rhythm Cues

NCT00523523 | Completed Phase 1

• 3 other identifiers: 1R03HDo51624-01A200065049IRB # 286-2005
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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

Conditions

Stroke; Hemiplegia

Keywords

Rehabilitation; hemiplegia; stroke; upper extremity; motor skills; therapy

Outcome Measures

Primary Outcomes (1)

• 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

  At 2 weeks, at 3 months, and at 6 months

Secondary Outcomes (1)

• 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

  At 2 weeks, 3 months and 6 months

Study Arms (2)

A

EXPERIMENTAL

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

Behavioral: Constraint-Induced Movement Therapy + auditory rhythm cues

F

ACTIVE COMPARATOR

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

Behavioral: Constraint-Induced Movement Therapy

Interventions

Constraint-Induced Movement Therapy + auditory rhythm cues BEHAVIORAL

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.

Also known as: Functional task practice, Forced use

A

Constraint-Induced Movement Therapy BEHAVIORAL

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.

F

Eligibility Criteria

• Age: 21 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead
• National Institutes of Health (NIH): collaborator
• US Department of Veterans Affairs: collaborator

Study Sites (1)

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

Gainesville, Florida, 32608, United States

Location

Related Publications (2)

• 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.

  PMID: 11900758 BACKGROUND

• 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.

  PMID: 17077374 BACKGROUND

MeSH Terms

Conditions

Stroke; Hemiplegia

Interventions

Constraint Induced Movement Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Exercise Therapy; Physical Therapy Modalities; Therapeutics; Rehabilitation

Study Officials

• Lorie G Richards, PhD

  University of Florida and North Florida/South Georgia Veterans Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2007
• First Posted: August 31, 2007
• Study Start: August 1, 2007
• Primary Completion: May 1, 2010
• Study Completion: June 1, 2010
• Last Updated: February 6, 2012

Record last verified: 2010-06

Locations

US (1)