This trial is active, not recruiting.

Condition stroke-induced he,iparesis in the arm
Treatments affected arm therapy + mental practice, affected arm therapy + stroke information
Phase phase 2/phase 3
Sponsor National Center for Complementary and Alternative Medicine (NCCAM)
Start date September 2009
End date September 2014
Trial size 100 participants
Trial identifier NCT01026896, Mental Practice in Stroke


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, outcomes assessor)
Primary purpose treatment
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.
(Active Comparator)
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.

Primary Outcomes

The Action Research Arm test
time frame: Twice before intervention phase; once directly after intervention phase; once 3 months after intervention phase

Eligibility Criteria

Male or female participants from 21 years up to 75 years old.

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)

Additional Information

Official title Mental Practice in Chronic Stroke-Induced Hemiparesis
Principal investigator Stephen Page, PhD
Trial information was received from ClinicalTrials.gov and was last updated in December 2009.
Information provided to ClinicalTrials.gov by National Center for Complementary and Alternative Medicine (NCCAM).