The Application of a Mental Practice Protocol in the Acute Inpatient Rehabilitation Setting

June 9, 2021 updated by: Adventist HealthCare

The Application of a Mental Practice Protocol to Increase the Functional Recovery of the Hemiparetic Upper Extremity in the Acute Inpatient Rehabilitation Setting

The purpose of this randomized controlled trial is to compare the effect of audio-guided mental practice (MP) and video-guided MP on the impairment and functional abilities of upper extremity (UE) hemiparesis following a stroke. Participants are recruited from Adventist Healthcare Rehabilitation Hospital. All participants must be less than one-month post-stroke with moderate UE hemiparesis. Eligible participants are randomly assigned to an experimental group, (MP or repetitive-task practice (RTP)), or the control group.

The MP groups will perform either audio-guided MP or video-guided MP, five days a week, with 20 repetitions of the following tasks: wiping a table, picking up a cup, brushing hair, and turning the pages of a book. The RTP group physically performed the same tasks. The control group received traditional stroke rehabilitation.

The investigators hypothesize that video MP will have greater improvements in UE impairments and functional abilities than audio MP, RTP, and/or traditional therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Rockville, Maryland, United States, 20850
        • Adventist Healthcare Rehabilitation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Primary diagnosis of stroke
  • Less than one-month post-stroke
  • Hemiparesis of one upper extremity
  • Moderate upper extremity impairment

Exclusion Criteria:

  • History of prior stroke
  • Comorbidities (severe neurological, orthopedic, rheumatoid, or cardiac impairments)
  • Severe spasticity
  • Severe cognitive impairments
  • Inability to perform mental imagery
  • Severe aphasia based on speech therapist evaluation
  • Low English proficiency
  • Severe pain

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Audio MP
Participants of the audio mental practice (MP) group will complete MP via audio-guided multisensory cues of one of four tasks: (1) wiping a table (2) picking up a cup (3) brushing hair and/or (4) turning the page of a book. The assigned motor task is based upon the functional abilities of the patient. MP will be performed followed by physical practice of the same task with a research therapist 3x/week and independent MP 2 days/week. Each audio recording consists of 20 repetitions of the task.
Other: Mental Practice
MP is the cognitive rehearsal of a motor task without physical movement, with the intent to improve motor performance. Mental practice can be completed via audio or video recording, visual prompts, written instructions, self-initiated or recorded pictures.
Other Names:
  • Mental Imagery
  • Motor Imagery
Experimental: Video MP
Participants of the video mental practice (MP) group will complete MP via video-guided multisensory cues of one of four tasks: (1) wiping a table (2) picking up a cup (3) brushing hair and/or (4) turning the page of a book. The assigned motor task is based upon the functional abilities of the patient. MP will be performed followed by physical practice of the same task with a research therapist 3x/week and independent MP 2 days/week. Each audio recording consists of 20 repetitions of the task.
Other: Mental Practice
MP is the cognitive rehearsal of a motor task without physical movement, with the intent to improve motor performance. Mental practice can be completed via audio or video recording, visual prompts, written instructions, self-initiated or recorded pictures.
Other Names:
  • Mental Imagery
  • Motor Imagery
Experimental: Repetitive-Task Practice
Participants of the repetitive-task practice group will complete repetitive practice of one of four tasks: (1) wiping a table (2) picking up a cup (3) brushing hair and/or (4) turning the page of a book. The assigned motor task is based upon the functional abilities of the patient. MP will be performed followed by physical practice of the same task with a research therapist 3x/week and independent MP 2 days/week. Each participant completed at least 20 repetitions of the task.
Other: Repetitive-Task Practice
Repetitive-Task Practice is the repetitive rehearsal of a motor task with the intent to improve motor performance.
Other Names:
  • Repetitive-Task Specific Practice
Active Comparator: Traditional Therapy
The control group received traditional occupational therapy stroke rehabilitation.
Other: Traditional Therapy
Traditional therapy includes traditional interventions completed in occupational therapy for patients following a stroke. These interventions include but are not limited to, range of motion, weight-bearing, massage, modalities, self-care training, and transfer training.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fugl Meyer Assessment-Upper Extremity Portion (FMA-UE) (Measuring pre/post intervention change)
Time Frame: Within 3 days of admission and within 3 days prior to discharge
The Fugl Meyer Assessment-upper extremity(FMA-UE) portion will be administered to measure the impairment of the upper extremity. Upper extremity movements are rated on 3-point ordinal scale where 0= unable to perform, 1= performs partially, 2= performs fully. Cumulative scores range from 0-66 where a lower score indicates increased impairment.
Within 3 days of admission and within 3 days prior to discharge
Wolf Motor Function Test (WMFT) (Measuring pre/post intervention change)
Time Frame: Within 3 days of admission and within 3 days prior to discharge
The Wolf Motor Function Test (WMFT) is used to measure the functional abilities of the UE. 15 tasks are performed including six timed joint-segment movements and eight timed integrative functional movements. Tasks are rated on a 6-point ordinal scale where 0= does not attempt to 5=movement appears to be normal. Timed and functional ability scores are calculated to indicate the functional abilities of the UE.
Within 3 days of admission and within 3 days prior to discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Adventist HealthCare

Collaborators

Texas Woman's University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 28, 2019

Primary Completion (Actual)

November 25, 2020

Study Completion (Actual)

November 25, 2020

Study Registration Dates

First Submitted

June 1, 2021

First Submitted That Met QC Criteria

June 9, 2021

First Posted (Actual)

June 16, 2021

Study Record Updates

Last Update Posted (Actual)

June 16, 2021

Last Update Submitted That Met QC Criteria

June 9, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AdventistHC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stroke

Clinical Trials on Mental Practice

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Africa

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe