Mental Practice Protocol With Severe Upper Extremity Hemiparesis

NCT05519306 | Unknown

• 1 other identifier: MPAdventist
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to examine the acceptability of patients and occupational therapists in following a mental practice protocol and examine the effects of mental practice with individuals with severe upper extremity hemiparesis (weakness) following a stroke. Mental practice is an adjunctive rehabilitation therapy that involves thinking about a motor task without actually moving. Research has shown that mental practice is a safe and feasible intervention that is effective in improving arm movements after a stroke. Patients in the study will participate in audio-guided mental practice, five days a week for two weeks, completing the following tasks: wiping a table and picking up a cup. The patients' ability to move their affected arm will be measured before and after the study to determine the effect of mental practice. Patients and occupational therapists will complete a survey to determine their feelings about performing or facilitating mental practice. The authors hypothesize that the majority of patients and occupational therapists will find mental practice to be feasible/acceptable for the recovery of the affected arm. Furthermore, we anticipate the majority of patients that complete the mental practice protocol will demonstrate improvements in their arm movements.

Conditions

Stroke; Upper Extremity Paresis

Keywords

mental practice; stroke; upper extremity; hemiparesis; rehabilitation interventions

Outcome Measures

Primary Outcomes (5)

• Fugl-Meyer Assessment-Upper Extremity portion- Change in scores from pre to post intervention

  A standardized quantitative measure of UE impairment commonly used in the post-stroke assessment of the hemiparetic UE.

  Within 3 days of admission and within 3 days following completion of the two weeks of mental practice protocol.

• Wolf Motor Function Test -Change in scores from pre to post intervention

  A standardized quantitative measure of UE motor ability through timed and functional tasks.

  Within 3 days of admission and within 3 days following completion of the two weeks of the mental practice protocol.

• Acceptability of Intervention Measure- Survey to assess the perception of the intervention.

  Assesses stakeholders' perception that a given intervention, service, or practice is agreeable or satisfactory.AIM is a four item survey in which participants rate their level of acceptability on a 5-point likert scale ranging from (1) completely disagree to (5) completely agree. Scores from each item are added up, where higher scores indicate greater acceptability. The test demonstrates good structural validity and test-retest reliability.

  Within 3 days following completion of the mental practice protocol.

• Intervention of Appropriateness Measure- Survey to assess the perception of fit of the intervention.

  Measures the stakeholders' perception of fit, relevance, or compatibility of an intervention or practice in a given practice setting and/or the perception of the fit of an intervention to address a particular problem.IAM is a 4 item survey in which participants rate their perception of appropriateness of the intervention on a 5-point likert scale ranging from (1) completely disagree to (5) completely agree. Scores from each item are added up, where higher scores indicate a greater appropriateness of the intervention. The test demonstrates good structural validity and test-retest reliability.

  Within 3 days following completion of the mental practice protocol.

• Feasibility of Intervention Measure - Survey of the perception of feasibility for the intervention

  Measures the extent to which an intervention can be successfully used in a given setting. A 4 item survey in which participants rate their perception of the feasibility of the intervention on a 5-point likert scale ranging from (1) completely disagree to (5) completely agree. Scores from each item are added up, where higher scores indicate greater feasibility. The test demonstrates good structural validity and test-retest reliability.

  Within 3 days following completion of the mental practice protocol.

Study Arms (2)

Mental Practice Patients

EXPERIMENTAL

Patients with upper extremity hemiparesis following a stroke.

Behavioral: Mental Practice

Occupational Therapists

NO INTERVENTION

Licensed, full-time, or part-time occupational therapists currently working in the inpatient rehabilitation unit of Adventist Healthcare Rehabilitation

Interventions

Mental Practice BEHAVIORAL

Each patient will perform the following two activity-based tasks via MP: wiping a table and picking up a cup. Prior to a scheduled OT session patients will perform MP of the assigned motor task. Following MP, a research therapist will facilitate repetitive task practice of the same motor task. MP sessions will be completed 5x/week for 2 weeks, (3x/week in combination with RTP, and 2x/week independently). The MP will be completed at an MP station equipped with a tablet and noise-canceling headphones. The audio recording will be from a first-person view as if they are performing it with their own UE. Each task will consist of 20 repetitions and will be facilitated by the use of multisensory cues (visual, tactile, auditory, and kinesthetic). For example, the task of picking up a cup will include describing how the drink looks (water with ice) and the temperature and feel of the cup (cold/moist).

Mental Practice Patients

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18-90
• less than one-month post-stroke
• hemiparesis of one UE
• severe UE impairment as defined by a score of \< 20 on the UE portion of the Fugl-Meyer Upper Extremity Assessment

You may not qualify if:

• history of prior stroke
• comorbidities (severe neurological, orthopedic, rheumatoid, or cardiac impairments), (3) severe spasticity
• severe cognitive impairments, score (\< 22 on Mini-Mental State Examination)
• inability to perform mental imagery score, \< 25 on Mental Imagery Questionnaire-Revised Second Version
• severe aphasia based on speech therapist evaluation
• non-English speaking
• severe pain \>5 on the 10-point visual analog scale

Sponsors & Collaborators

• Adventist HealthCare: lead
• Center for Student Research Texas Woman's University: collaborator

Study Sites (1)

Adventist Healthcare Rehabilitation

Rockville, Maryland, 20906, United States

RECRUITING

MeSH Terms

Conditions

Stroke; Paresis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Teresa M Green, MSOT

  Adventist Healthcare Rehabilitation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Teresa M Green, MSOT

CONTACT

240-864-6196; tgreen3@adventisthealthcare.com

Study Design

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

Model Details: A feasibility study with pretest/posttest design will be deployed to address the research aims. A feasibility study is considered the most appropriate design due to the lack of MP research with this population. Acceptability and limited efficacy will be the specific areas of focus of feasibility. The findings from this study can be used to indicate if a larger, randomized controlled trial with individuals with severe UE hemiparesis is necessary.

Study Record Dates

• First Submitted: August 17, 2022
• First Posted: August 29, 2022
• Study Start: August 22, 2022
• Primary Completion: November 1, 2022
• Study Completion: December 1, 2022
• Last Updated: September 7, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)