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Mental Practice in Chronic, Stroke Induced Hemiparesis

The Ohio State University logo

The Ohio State University

Status

Completed

Conditions

Hemiparesis

Treatments

Behavioral: Mental Practice Group
Behavioral: Active Control Group

Study type

Interventional

Funder types

Other

Identifiers

NCT01651533
2011H0216

Details and patient eligibility

About

Stroke is the leading cause of disability in the United States, producing motor impairments that compromise performance of valued activities. Hemiparesis (or weakness in one arm) is particularly disabling, is the primary impairment underlying stroke-related disability, and the most frequent impairment treated by therapists in the United States. This study will test efficacy of a promising technique in reducing arm disability and increasing function, thereby improving outcomes and health, reducing care costs, for community dwelling patients with stroke-induced hemiparesis.

Enrollment

100 patients

Sex

All

Ages

21 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • a Fugl-Meyer score > 27, which is indicative of minimal to moderate arm impairment;
  • stroke experienced > 6 months prior to study enrollment;
  • minimal cognitive impairment, a score > 25 on the Folstein Mini Mental Status Examination (MMSE);
  • age > 21 years old and < 80 years old;
  • have experienced one clinical stroke as verified by a physician;
  • discharged from all forms of physical rehabilitation targeting the affected arm.

Exclusion criteria

  • < 21 years old;
  • excessive pain in the affected hand, arm or shoulder, as measured by a score > 5 on a 10-point visual analog scale;
  • excessive spasticity in the affected biceps, triceps, wrist, or fingers, as defined as a score of greater than or equal to 2 on the Modified Ashworth Spasticity Scale;
  • currently participating in any experimental rehabilitation or drug studies targeting UE;
  • mirrors movements(i.e., involuntary movements by the unaffected hand during attempts at unilateral movement by the stroke-affected hand during attempts at unilateral movement by the stroke-affected hand);
  • history of parietal stroke (because some data suggest that ability to estimate manual motor performance through mental imagery is disturbed after parietal lobe damage);
  • affected arm joint restriction that in the opinion of the investigator would hinder study participation

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

100 participants in 2 patient groups

Experimental: Mental Practice Group
Experimental group
Treatment:
Behavioral: Mental Practice Group
Active Comparator: Active Control Group
Active Comparator group
Treatment:
Behavioral: Active Control Group

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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