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

Primary Purpose

Stroke, Upper Extremity Paresis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mental Practice
Repetitive-Task Practice
Traditional Therapy
Sponsored by
Adventist HealthCare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring mental practice, stroke, upper extremity, hemiparesis, rehabilitation interventions

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Adventist Healthcare Rehabilitation

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Audio MP

Video MP

Repetitive-Task Practice

Traditional Therapy

Arm Description

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.

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.

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.

The control group received traditional occupational therapy stroke rehabilitation.

Outcomes

Primary Outcome Measures

Fugl Meyer Assessment-Upper Extremity Portion (FMA-UE) (Measuring pre/post intervention change)
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.
Wolf Motor Function Test (WMFT) (Measuring pre/post intervention change)
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.

Secondary Outcome Measures

Full Information

First Posted
June 1, 2021
Last Updated
June 9, 2021
Sponsor
Adventist HealthCare
Collaborators
Texas Woman's University
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1. Study Identification

Unique Protocol Identification Number
NCT04927728
Brief Title
The Application of a Mental Practice Protocol in the Acute Inpatient Rehabilitation Setting
Official Title
The Application of a Mental Practice Protocol to Increase the Functional Recovery of the Hemiparetic Upper Extremity in the Acute Inpatient Rehabilitation Setting
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
January 28, 2019 (Actual)
Primary Completion Date
November 25, 2020 (Actual)
Study Completion Date
November 25, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Adventist HealthCare
Collaborators
Texas Woman's University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Upper Extremity Paresis
Keywords
mental practice, stroke, upper extremity, hemiparesis, rehabilitation interventions

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Audio MP
Arm Type
Experimental
Arm Description
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.
Arm Title
Video MP
Arm Type
Experimental
Arm Description
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.
Arm Title
Repetitive-Task Practice
Arm Type
Experimental
Arm Description
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.
Arm Title
Traditional Therapy
Arm Type
Active Comparator
Arm Description
The control group received traditional occupational therapy stroke rehabilitation.
Intervention Type
Other
Intervention Name(s)
Mental Practice
Other Intervention Name(s)
Mental Imagery, Motor Imagery
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Repetitive-Task Practice
Other Intervention Name(s)
Repetitive-Task Specific Practice
Intervention Description
Repetitive-Task Practice is the repetitive rehearsal of a motor task with the intent to improve motor performance.
Intervention Type
Other
Intervention Name(s)
Traditional Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Fugl Meyer Assessment-Upper Extremity Portion (FMA-UE) (Measuring pre/post intervention change)
Description
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.
Time Frame
Within 3 days of admission and within 3 days prior to discharge
Title
Wolf Motor Function Test (WMFT) (Measuring pre/post intervention change)
Description
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.
Time Frame
Within 3 days of admission and within 3 days prior to discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Adventist Healthcare Rehabilitation
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States

12. IPD Sharing Statement

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

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