Clinical trial NCT04856527: Motor Control Physical Therapist Support Stroke
Official title: The Motor Control Consequences of Excessive Physical Therapist Support in Individuals With Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: physical therapy
postural control
supra-postural task
stroke
motor control
contextual factors
variability
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: TriHealth Inc.
First posted: 2021-04-23
Enrollment: 25
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility 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.

Primary outcomes:
measure: Center of Pressure Path Length
timeFrame: 10 minutes of practice
measure: Standard Deviation of Center of Pressure
timeFrame: After 10 minutes of practice
measure: Percent Determinism of Postural Sway
timeFrame: After 10 minutes of practice
measure: Entropy (Sample Entropy)
timeFrame: After 10 minutes of practice
measure: Percent Correct
timeFrame: After 10 minutes of practice
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati Center for Cognition, Action, and Perception
state: Ohio
Study officials:
References: