NCT04927728

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 28, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 16, 2021

Completed
Last Updated

June 16, 2021

Status Verified

June 1, 2021

Enrollment Period

1.8 years

First QC Date

June 1, 2021

Last Update Submit

June 9, 2021

Conditions

Keywords

mental practicestrokeupper extremityhemiparesisrehabilitation interventions

Outcome Measures

Primary Outcomes (2)

  • 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.

    Within 3 days of admission and within 3 days prior to discharge

  • 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.

    Within 3 days of admission and within 3 days prior to discharge

Study Arms (4)

Audio MP

EXPERIMENTAL

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

Video MP

EXPERIMENTAL

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

Repetitive-Task Practice

EXPERIMENTAL

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

Traditional Therapy

ACTIVE COMPARATOR

The control group received traditional occupational therapy stroke rehabilitation.

Other: Traditional Therapy

Interventions

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.

Also known as: Mental Imagery, Motor Imagery
Audio MPVideo MP

Repetitive-Task Practice is the repetitive rehearsal of a motor task with the intent to improve motor performance.

Also known as: Repetitive-Task Specific Practice
Repetitive-Task Practice

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.

Traditional Therapy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adventist Healthcare Rehabilitation

Rockville, Maryland, 20850, United States

Location

MeSH Terms

Conditions

StrokeParesis

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2021

First Posted

June 16, 2021

Study Start

January 28, 2019

Primary Completion

November 25, 2020

Study Completion

November 25, 2020

Last Updated

June 16, 2021

Record last verified: 2021-06

Locations