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CompletedNCT01651533Updated Feb 10, 2022

Mental Practice in Chronic, Stroke Induced Hemiparesis

An interventional study of Mental Practice Group and Active Control Group in Hemiparesis, sponsored by Ohio State University. Completed at 2 sites in United States. Open to participants aged 21 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-02-10.

Sponsored by Ohio State University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
21 Years to 80 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Hemiparesis

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Keywords

  • Mental practice group
  • Active control group
03

In context

Paresis

530 studies on the registry are indexed under Paresis; 116 are open to participants now.

This study's enrollment of 100 is above the median of 36 across 456 interventional studies indexed under Paresis.

Browse Paresis studies →

Lead sponsor

Ohio State University is the lead sponsor of 661 studies on the registry; 148 are open to participants now.

Of its 66 completed or terminated interventional studies of FDA-regulated products, 49 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    Experimental: Mental Practice Group

    Behavioral: Mental Practice Group

  • Active comparator
    Active Comparator: Active Control Group

    Behavioral: Active Control Group

Interventions

  • BehavioralMental Practice Group

    Patients are administered rehabilitative therapy targeting their affected arms on 3 days/week during a ten week period. Directly after the therapy session, they participate in targeted mental practice session in which they cognitively rehearse the movement that they just physically practiced.

  • BehavioralActive Control Group

    Individuals assigned to this group are administrated rehabilitative therapy targeting their affected arms in half four increments, occurring 3 days/week for 10 weeks. They also are administered an intervention in which they listen to a relaxation tape and/or tapes in which they receive instructions on exercises and information on stroke care.

06

What researchers measure

Primary outcomes

  1. Change in movement in the affected fingers and wrist as measured by the Action Research Arm Test

    This is a measure that examines the participant's ability to use the affected wrist and fingers to grasp, pinch, and grip small objects (i.e., fine motor skills). Gross movements(e.g., touching the top of the head using the affected arm) are also briefly examined. The investigator will measure changes in these abilities. We will do this by administering the measure before and after participation in the study to determine if a change occurred in patients' movement abilities.

    Time frame: 2-3 weeks before intervention; 1 week after intervention; 3 months after intervention

07

Study locations

2 sites
  • Metrohealth
    Cleveland, Ohio, United States
  • The Ohio State University
    Columbus, Ohio, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2010, a primary completion of Aug 2016 and a completion of Dec 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 23, 2012
First posted
Jul 27, 2012
Start
Sep 2010
Primary completionActual
Aug 2016
CompletionActual
Dec 2016
Last update
Feb 10, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 10, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01651533
Responsible party
Sponsor
First posted
Jul 27, 2012
Start date
Sep 2010
Primary completion
Aug 2016
Completion
Dec 2016
Last update
Feb 10, 2022

Study contacts

Stephen Page, PhD,M.S.
principal investigator · Ohio State University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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