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Motor Control Physical Therapist Support Stroke

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ClinicalTrials.gov Identifier: NCT04856527
Recruitment Status : Recruiting
First Posted : April 23, 2021
Last Update Posted : June 3, 2021
Sponsor:
Collaborator:
TriHealth Inc.
Information provided by (Responsible Party):
Sarah Schwab, University of Cincinnati

Brief Summary:
The purpose of this study is to systematically determine the effect of unnecessary physical therapist assistance in individuals after stroke during the practice of an upper limb task on an individual's task performance and their underlying motor control patterns when learning (or re-learning) motor skills.

Condition or disease Intervention/treatment Phase
Stroke Behavioral: Physical therapist support Not Applicable

Detailed Description:

Independent motor task performance is the most highly prioritized outcome of physical therapy for individuals with motor disability. Accordingly, a key priority for physical therapists in multiple practice settings is the advancement of functional motor independence. Therapists must determine when a patient requires assistance (e.g., verbal cues, physical support) to complete a motor task and when a patient is able to execute a motor skill with less assistance. If a therapist does not provide enough support, the patient is at risk for unsuccessful task performance. As such, therapists often default to providing a higher level of assistance.

An individual following stroke, for instance, may demonstrate an increased magnitude of postural sway while completing self-care activities at the sink. A therapist may decide to provide physical support for the patient to decrease sway variability, whether or not the patient requires this support to maintain performance. The motor control consequences of providing this assistance (thus constraining movement variability and providing fewer options for adapting movement) when assistance is actually not needed is unknown. The purpose of this study is to systematically determine the effect of unnecessary assistance during the practice of an upper limb task on functional performance and underlying motor control patterns when learning (or re-learning) motor skills in individuals with stroke. The insights gained from the current project will have the potential to improve the currently available physical therapy interventions for individuals with stroke.

The effects of unnecessary physical therapist support will be examined in terms of upper limb task performance, retention, and transfer, and in terms of the postural control supporting task performance. The study is currently planned for individuals with stroke. Participants will be required to maintain the position of a virtual laser within a target while standing. An experimental group will receive postural support (physical assistance to maintain upright posture) during a practice period in order to specifically determine the effect of postural support on upper limb task performance and postural sway patterns. Participants will also engage in a light finger force production transfer task to ascertain the influence of postural support on a different supra-postural task.

It is hypothesized that providing unnecessary assistance (and thus limiting independence) during practice of a novel motor task will result in (a) faster improvements in task performance but reduced retention and more limited transfer to another, similar task; and (b) reduced task- sensitive postural sway adjustments (measured in terms of both the quantity and temporal structure) during practice, at transfer, and at retention, reflecting reduced adaptability of postural patterns to task demands.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: The Motor Control Consequences of Excessive Physical Therapist Support in Individuals With Stroke
Actual Study Start Date : June 2, 2021
Estimated Primary Completion Date : July 1, 2022
Estimated Study Completion Date : July 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arm Intervention/treatment
Experimental: Experimental Group
Participants will receive physical therapist support to reduce postural sway while completing a precision aiming task in virtual reality, whether or not they require the support.
Behavioral: Physical therapist support
Participants will receive physical therapist support to reduce postural sway variability while completing an upper limb precision aiming task in virtual reality.

No Intervention: Control Group
Participants will receive no physical therapist support while completing the task.



Primary Outcome Measures :
  1. Center of pressure path length [ Time Frame: Change from initial assessment to after 10 minutes of practice; during practice (10 minutes total) ]
    The amount of displacement of the location of the (resultant) vertical ground reaction force vector.

  2. Standard deviation of center of pressure [ Time Frame: Change from initial assessment to after 10 minutes of practice; during practice (10 minutes total) ]
    Variability of center of pressure trajectory for each plane.

  3. Recurrence quantification analysis [ Time Frame: Change from initial assessment to after 10 minutes of practice; during practice (10 minutes total) ]
    Quantifies the patterning, non-stationarity, and complexity of biological time series through the analysis of local recurrences in a reconstructed phase space.

  4. Entropy (Sample entropy or multiscale entropy) [ Time Frame: Change from initial assessment to after 10 minutes of practice; during practice (10 minutes total) ]
    Evaluates the predictability of the next state of a system, given what is known about the current state of a system.

  5. Error (root mean square error) [ Time Frame: Change from initial assessment to after 10 minutes of practice; during practice (10 minutes total) ]
    Deviation of laser from target; deviation of force production from target force.



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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Between 45 and 80 years at time of consenting
  2. Previous diagnosis of stroke for which they sought treatment (> 1 month prior to enrollment)
  3. Able to communicate with investigators, follow a 2-step command and correctly answer consent comprehension questions
  4. Independence or modified independence during ambulation (defined as the ability to ambulate with no physical assist and walk with an assistive device as needed) for at least 30 ft.
  5. Score 0-3 on the Modified Rankin Scale, which indicates complete independence to moderate disability but able to walk without assistance.
  6. Maintain standing balance for > 2 minutes with no physical support.
  7. Maintain grasp of a handheld object with at least one hand.

Exclusion Criteria:

  1. Limited language abilities, deafness, blindness, or serious motor impairment that outright prevents performance of the experimental tasks (e.g., severe lower extremity spasticity)
  2. Pregnancy.
  3. Pain with weightbearing > 4/10.
  4. Inability to answer consent questions and follow simple 1-step commands.
  5. Any other medical condition that would preclude the valid administration of the study measures, specifically seizure disorders or additional neurologic conditions beyond stroke.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04856527


Contacts
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Contact: Sarah M Schwab schwabsr@mail.uc.edu

Locations
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United States, Ohio
University of Cincinnati Center for Cognition, Action, and Perception Recruiting
Cincinnati, Ohio, United States, 45221
Contact: Sarah M Schwab, PT, DPT, MA       schwabsr@mail.uc.edu   
Principal Investigator: Sarah M Schwab, PT, DPT, MA         
Sponsors and Collaborators
University of Cincinnati
TriHealth Inc.
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Responsible Party: Sarah Schwab, Principal Investigator, University of Cincinnati
ClinicalTrials.gov Identifier: NCT04856527    
Other Study ID Numbers: 2020-1072
First Posted: April 23, 2021    Key Record Dates
Last Update Posted: June 3, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Analytic code and other study materials may be shared on PI's Open Science Framework (OSF) page.
Supporting Materials: Analytic Code
Time Frame: Within 6 months of study completion or after the primary manuscript from this study is accepted for publication and will likely remain available indefinitely
URL: https://osf.io/wq2rf/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sarah Schwab, University of Cincinnati:
physical therapy
postural control
supra-postural task
stroke
motor control
contextual factors
variability
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases