Mental Practice Efficacy in Stroke-Induced Hemiparesis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT01026896
First received: December 4, 2009
Last updated: NA
Last verified: December 2009
History: No changes posted

December 4, 2009
December 4, 2009
September 2009
September 2014   (final data collection date for primary outcome measure)
The Action Research Arm test [ Time Frame: Twice before intervention phase; once directly after intervention phase; once 3 months after intervention phase ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Mental Practice Efficacy in Stroke-Induced Hemiparesis
Mental Practice in Chronic Stroke-Induced Hemiparesis

This study will examine whether mentally rehearsing moving one's affected arm after stroke will improve the quality and amount of affected arm movement. The study will enroll 100 people who have experienced a stroke > 1 year ago, and who still have difficulty moving their affected wrists and hands. Eligible subjects also cannot have any implanted devices or metal above the waist. Each patient will receive 10 weeks of therapy targeting their affected arms. Half of the subjects will also be administered mental rehearsal of the exercises that they are physically performing, while the other half will be administered stroke information and information on additional exercises that they can perform targeting their affected arms. Tests of arm movement and use will be given before and after intervention, as well as 3 months after intervention, to measure response to these interventions. We will also administer brain scans before and after intervention. We hypothesize that people receiving the mantal and physical rehearsal will show larger arm movement and use changes.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Stroke-induced he,Iparesis in the Arm
  • Behavioral: Affected Arm Therapy + Mental Practice
    Subjects will be administered 10 weeks of rehabilitative therapy targeting the affected arm. Mental practice of the rehabilitative exercises performed will occur directly after therapy.
  • Behavioral: Affected Arm Therapy + Stroke Information
    Patients will be administered 10 weeks of rehabilitative therapy targeting their affected arms. Directly after their therapy sessions, subjects will be administered information on stroke and exercises targeting their affected arms.
  • Experimental: Affected Arm Therapy + Mental Practice
    Intervention: Behavioral: Affected Arm Therapy + Mental Practice
  • Active Comparator: Affected Arm Therapy + Stroke Information
    Intervention: Behavioral: Affected Arm Therapy + Stroke Information
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
September 2014
September 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:(1) Minimum motor criteria: able to at least actively flex the affected wrist a minimum of 10 degrees and actively flex the MP joints of the thumb, and at least 2 additional MP joints in two additional fingers at least 10 degrees. These movements must be repeated at least 3 times in one minute. Additionally, subjects in this study will have to exhibit the aforementioned active range of motion and a FM score of 28 to be eligible for study inclusion. (2) stroke experienced > 1 year prior to study enrollment; (3) a score > 25 on the Folstein Mini Mental Status Examination (MMSE), (4) age > 21 < 75; (5) have experienced one stroke; (6) discharged from all forms of physical rehabilitation.

Exclusion Criteria:(1) < 21 years old; (2) excessive pain in the affected hand, arm or shoulder, as measured by a score > 5 on a 10-point visual analog scale; (3) excessive spasticity in the affected biceps, triceps, wrist, or fingers, as defined as a score of > 2 on the Modified Ashworth Spasticity Scale;92 (4) currently participating in any experimental rehabilitation or drug studies; (5) mirror movements (i.e., involuntary movements by the unaffected hand during attempts at unilateral movement by the stroke-affected hand); (6) contraindication to a MRI procedure (i.e., metal implants, claustrophobia)

Both
21 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01026896
Mental Practice in Stroke
Not Provided
Stephen J. Page, University of Cincinnati
National Center for Complementary and Alternative Medicine (NCCAM)
Not Provided
Principal Investigator: Stephen Page, PhD University of Cincinnati
National Center for Complementary and Alternative Medicine (NCCAM)
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP