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Completed

NCT Number: NCT04856527

Motor Control Physical Therapist Support Stroke

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.

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Key information

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Cincinnati Center for Cognition, Action, and Perception

Cincinnati, Ohio, 45221, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Between 45 and 80 years at time of consenting
  • Previous diagnosis of stroke for which they sought treatment (> 1 month prior to enrollment)
  • Able to communicate with investigators, follow a 2-step command and correctly answer consent comprehension questions
  • 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.
  • Score 0-3 on the Modified Rankin Scale, which indicates complete independence to moderate disability but able to walk without assistance.
  • Maintain standing balance for > 2 minutes with no physical support.
  • Maintain grasp of a handheld object with at least one hand.

Exclusion criteria

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

Treatment and study plan

Physical therapist support

Behavioral

Participants will receive physical therapist support to reduce postural sway variability while completing an upper limb precision aiming task in virtual reality.

Primary outcomes

  1. Center of Pressure Path Length

    Time frame: 10 minutes of practice

    The amount of displacement of the location of the (resultant) vertical ground reaction force vector.

    Results only presented as the mean difference between groups, as only the paretic limb was used for this portion of the study. There are no results to report for the non-paretic limb.

  2. Standard Deviation of Center of Pressure

    Time frame: After 10 minutes of practice

    Variability of center of pressure trajectory.

  3. Percent Determinism of Postural Sway

    Time frame: After 10 minutes of practice

    Quantifies the patterning, non-stationarity, and complexity of biological time series through the analysis of local recurrences in a reconstructed phase space. Highter values of percent determinism indicate more regularity in postural sway.

  4. Entropy (Sample Entropy)

    Time frame: After 10 minutes of practice

    Evaluates the predictability of the next state of a system, given what is known about the current state of a system. Higher values of SampEn indicate less regularity; lower values indicate more regularity. Outcome measure reported as a ratio of anterior-posterior to medial-lateral SampEn values.

  5. Percent Correct

    Time frame: After 10 minutes of practice

    Percent time on target.

Sponsors and collaborators

Lead sponsor

University of Cincinnati

Other

Collaborators

  • TriHealth Inc.

Registry information

Official study title

The Motor Control Consequences of Excessive Physical Therapist Support in Individuals With Stroke

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 23, 2021
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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