Motor Control Physical Therapist Support Stroke
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Physical therapist support
Sponsored by

About this trial
This is an interventional basic science trial for Stroke focused on measuring physical therapy, postural control, supra-postural task, stroke, motor control, contextual factors, variability
Eligibility Criteria
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.
Sites / Locations
- University of Cincinnati Center for Cognition, Action, and Perception
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental Group
Control Group
Arm Description
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.
Participants will receive no physical therapist support while completing the task.
Outcomes
Primary Outcome Measures
Center of pressure path length
The amount of displacement of the location of the (resultant) vertical ground reaction force vector.
Standard deviation of center of pressure
Variability of center of pressure trajectory for each plane.
Recurrence quantification analysis
Quantifies the patterning, non-stationarity, and complexity of biological time series through the analysis of local recurrences in a reconstructed phase space.
Entropy (Sample entropy or multiscale entropy)
Evaluates the predictability of the next state of a system, given what is known about the current state of a system.
Error (root mean square error)
Deviation of laser from target; deviation of force production from target force.
Secondary Outcome Measures
Full Information
NCT ID
NCT04856527
First Posted
April 14, 2021
Last Updated
April 28, 2022
Sponsor
University of Cincinnati
Collaborators
TriHealth Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04856527
Brief Title
Motor Control Physical Therapist Support Stroke
Official Title
The Motor Control Consequences of Excessive Physical Therapist Support in Individuals With Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
June 2, 2021 (Actual)
Primary Completion Date
October 12, 2021 (Actual)
Study Completion Date
October 12, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cincinnati
Collaborators
TriHealth Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
physical therapy, postural control, supra-postural task, stroke, motor control, contextual factors, variability
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Participants will receive no physical therapist support while completing the task.
Intervention Type
Behavioral
Intervention Name(s)
Physical therapist support
Intervention Description
Participants will receive physical therapist support to reduce postural sway variability while completing an upper limb precision aiming task in virtual reality.
Primary Outcome Measure Information:
Title
Center of pressure path length
Description
The amount of displacement of the location of the (resultant) vertical ground reaction force vector.
Time Frame
Change from initial assessment to after 10 minutes of practice; during practice (10 minutes total)
Title
Standard deviation of center of pressure
Description
Variability of center of pressure trajectory for each plane.
Time Frame
Change from initial assessment to after 10 minutes of practice; during practice (10 minutes total)
Title
Recurrence quantification analysis
Description
Quantifies the patterning, non-stationarity, and complexity of biological time series through the analysis of local recurrences in a reconstructed phase space.
Time Frame
Change from initial assessment to after 10 minutes of practice; during practice (10 minutes total)
Title
Entropy (Sample entropy or multiscale entropy)
Description
Evaluates the predictability of the next state of a system, given what is known about the current state of a system.
Time Frame
Change from initial assessment to after 10 minutes of practice; during practice (10 minutes total)
Title
Error (root mean square error)
Description
Deviation of laser from target; deviation of force production from target force.
Time Frame
Change from initial assessment to after 10 minutes of practice; during practice (10 minutes total)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
University of Cincinnati Center for Cognition, Action, and Perception
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45221
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Analytic code and other study materials may be shared on PI's Open Science Framework (OSF) page.
IPD Sharing 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
IPD Sharing URL
https://osf.io/wq2rf/
Learn more about this trial
Motor Control Physical Therapist Support Stroke
We'll reach out to this number within 24 hrs