Mental Imagery to Reduce Motor Deficits in Stroke

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Andrew Butler, PhD, Emory University
ClinicalTrials.gov Identifier:
NCT00379392
First received: September 19, 2006
Last updated: August 9, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Stroke
Behavioral: Mental Imagery only
Procedure: Mental Imagery and Constraint induced therapy
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mental Imagery to Reduce Motor Deficits in Stroke

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Wolf Motor Function Test [ Time Frame: Pre-treatment, Post-treatment, and 3 month follow-up ] [ Designated as safety issue: No ]
  • Fugl-Meyer Motor Assessment Test [ Time Frame: Pre-treatment, Post-treatment, and 3 month follow-up ] [ Designated as safety issue: No ]
  • Movement Imagery Questionnaire [ Time Frame: Pre-treatment, Post-treatment, and 3 month follow-up ] [ Designated as safety issue: No ]
  • Vividness of Movement Imagery Questionnaire [ Time Frame: Pre-treatment, Post-treatment, and 3 month follow-up ] [ Designated as safety issue: No ]
  • Center for Epidemiologic Studies Depression scale [ Time Frame: Pre-treatment, Post-treatment, and 3 month follow-up ] [ Designated as safety issue: No ]
  • Stroke Impact Scale [ Time Frame: Pre-treatment, Post-treatment, and 3 month follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sirigu's break test [ Time Frame: Pre-treatment, Post-treatment, and 3 month follow-up ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: January 2003
Study Completion Date: August 2011
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mental Imagery and CIT
Mental Imagery and Constraint Induced Therapy
Procedure: Mental Imagery and Constraint induced therapy
Listening to an audio tape to enhance mental imagery AND participation in constraint induced therapy
Active Comparator: Mental Imagery only
Mental Imagery only
Behavioral: Mental Imagery only
Listening to an audio tape to enhance mental imagery of functional activities of the affected upper extremity

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. 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.
  3. Participants who are 3-12 months post-stroke (first-time clinical CVA) of ischemic or hemorrhagic type at the beginning of the intervention.
  4. Participants with sensory loss will be eligible.
  5. Participants must score at least 24 on the MMSE. Memory deficits associated with dementia are the main concern with this inclusion criterion.
  6. 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.
  7. Each participant must have physician approval for participation in the therapy to rule out major medical problems.
  8. Participants must be over the age of 18 years. No upper age limits will be set.
  9. Participants must have sufficient endurance and stamina determined by clinical judgment to carry out the requirements of the CI therapy trial.
  10. Participants with unilateral perceptual neglect will be accepted if they meet the other inclusion criteria.
  11. 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.
  12. Transportation to and from Emory Center for Rehabilitation.

Exclusion Criteria:

  1. Score of less than 24 on the MMSE.
  2. A first stroke less than 3 months or more than 12 months prior to enrollment.
  3. Less than 18 years of age.
  4. Clinical judgment of excessive frailty or lack of stamina (e.g., cannot attend to instructions, stay awake, engage in functional activities, etc.).
  5. Serious uncontrolled medical conditions.
  6. Excessive pain in any joint or more affected extremity that could limit ability to cooperate with the intervention, as judged by the examining clinician.
  7. 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.
  8. Unable to stand independently for 2 minutes, transfer independently to and from the toilet or perform sit-to-stand.
  9. 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.
  10. Receiving any anti-spasticity drugs orally at the time of expected participation.
  11. Received phenol injections less than 12 months prior to participation.
  12. Damage to the parietal area of the brain
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00379392

Locations
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Andrew J Butler, PhD, MPT Emory University
  More Information

No publications provided

Responsible Party: Andrew Butler, PhD, Prinicipal investigator, Emory University
ClinicalTrials.gov Identifier: NCT00379392     History of Changes
Other Study ID Numbers: 338-2003, R21 AT002138-03
Study First Received: September 19, 2006
Last Updated: August 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
Stroke
Mental Imagery
Constraint Induced Therapy

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on July 28, 2014