Mental Imagery to Reduce Motor Deficits in Stroke

NCT00379392 | Completed Phase 1 DMC

• 2 other identifiers: 338-2003R21AT002138-03
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of the proposed study is to collect data in an effort to estimate the clinical effectiveness of implementing repetitive task practice (RTP) in addition to mental imagery training (MIT) to improve upper extremity motor function and the quality of life of chronic stroke patients.

Conditions

Stroke

Keywords

Stroke; Mental Imagery; Constraint Induced Therapy

Outcome Measures

Primary Outcomes (6)

• Wolf Motor Function Test

  Pre-treatment, Post-treatment, and 3 month follow-up

• Fugl-Meyer Motor Assessment Test

  Pre-treatment, Post-treatment, and 3 month follow-up

• Movement Imagery Questionnaire

  Pre-treatment, Post-treatment, and 3 month follow-up

• Vividness of Movement Imagery Questionnaire

  Pre-treatment, Post-treatment, and 3 month follow-up

• Center for Epidemiologic Studies Depression scale

  Pre-treatment, Post-treatment, and 3 month follow-up

• Stroke Impact Scale

  Pre-treatment, Post-treatment, and 3 month follow-up

Secondary Outcomes (1)

• Sirigu's break test

  Pre-treatment, Post-treatment, and 3 month follow-up

Study Arms (2)

Mental Imagery and CIT

EXPERIMENTAL

Mental Imagery and Constraint Induced Therapy

Procedure: Mental Imagery and Constraint induced therapy

Mental Imagery only

ACTIVE COMPARATOR

Mental Imagery only

Behavioral: Mental Imagery only

Interventions

Mental Imagery only BEHAVIORAL

Listening to an audio tape to enhance mental imagery of functional activities of the affected upper extremity

Mental Imagery only

Mental Imagery and Constraint induced therapy PROCEDURE

Listening to an audio tape to enhance mental imagery AND participation in constraint induced therapy

Mental Imagery and CIT

Eligibility Criteria

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

You may qualify if:

• Minimum Motor Criteria Active wrist extension of no less than 10 degrees, 10 degrees of thumb abduction/extension and at least two additional digits. Must be able to perform at least 3 times in 1 minute.
• Passive Range of Motion At least 90 degrees of shoulder flexion and abduction, 45 degrees of shoulder external rotation, no less than -30 degrees of elbow extension, 45 degrees of forearm supination (from neutral), 45 degrees of forearm pronation (from neutral), wrist extension to neutral, finger extension (all digits) such that no MCP joint has greater than a 30 degree contracture.
• Participants who are 3-12 months post-stroke (first-time clinical CVA) of ischemic or hemorrhagic type at the beginning of the intervention.
• Participants with sensory loss will be eligible.
• Balance Criteria: Participants must be able to transfer to and from the toilet independently and safely, stand from a sitting position and maintain standing balance independently for at least two minutes with or without their own upper extremity support.
• Each participant must have physician approval for participation in the therapy to rule out major medical problems.
• Participants must be over the age of 18 years. No upper age limits will be set.
• Participants must have sufficient endurance and stamina determined by clinical judgment to carry out the requirements of the CI therapy trial.
• Participants on medication will not be excluded. Subjects will be excluded if they have received Botox injections to their affected UE less than 3 months prior to participation, if they have received Phenol block injections less than 12 months prior to participation, if they are receiving intrathecal Baclofen, or if they are receiving Baclofen or Dantrium orally at the time of the study.
• Transportation to and from Emory Center for Rehabilitation.

You may not qualify if:

• Score of less than 24 on the MMSE.
• A first stroke less than 3 months or more than 12 months prior to enrollment.
• Less than 18 years of age.
• Clinical judgment of excessive frailty or lack of stamina (e.g., cannot attend to instructions, stay awake, engage in functional activities, etc.).
• Serious uncontrolled medical conditions.
• Excessive pain in any joint or more affected extremity that could limit ability to cooperate with the intervention, as judged by the examining clinician.
• Passive ROM less than 90 degrees of shoulder flexion and abduction, less than 45 degrees of shoulder external rotation, greater than 30 degree flexion contracture of elbow, less than 45 degrees of forearm supination and pronation from neutral, less than neutral wrist extension and greater than 30 degree flexion contracture of any MCP joint.
• Unable to stand independently for 2 minutes, transfer independently to and from the toilet or perform sit-to-stand.
• Have received injections of anti-spasticity drugs into upper extremity musculature within the past 3 months, or wish to have drugs injected in the foreseeable future.
• Receiving any anti-spasticity drugs orally at the time of expected participation.
• Received phenol injections less than 12 months prior to participation.
• Damage to the parietal area of the brain

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Andrew J Butler, PhD, MPT

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal investigator

Study Record Dates

• First Submitted: September 19, 2006
• First Posted: September 21, 2006
• Study Start: January 1, 2003
• Primary Completion: July 1, 2008
• Study Completion: August 1, 2011
• Last Updated: April 14, 2015

Record last verified: 2015-04

Locations

US (1)