Motor Control Physical Therapist Support Stroke

NCT04856527 | Completed Results

• 1 other identifier: 2020-1072
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

physical therapy; postural control; supra-postural task; stroke; motor control; contextual factors; variability

Outcome Measures

Primary Outcomes (5)

• Center of Pressure Path Length

  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.

  10 minutes of practice

• Standard Deviation of Center of Pressure

  Variability of center of pressure trajectory.

  After 10 minutes of practice

• Percent Determinism of Postural Sway

  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.

  After 10 minutes of practice

• Entropy (Sample Entropy)

  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.

  After 10 minutes of practice

• Percent Correct

  Percent time on target.

  After 10 minutes of practice

Study Arms (2)

Experimental Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

Participants will receive no physical therapist support while completing the task.

Interventions

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.

Experimental Group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Cincinnati: lead
• TriHealth Inc.: collaborator

Study Sites (1)

University of Cincinnati Center for Cognition, Action, and Perception

Cincinnati, Ohio, 45221, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Sarah Schwab
• Organization: University of Cincinnati

schwabsr@mail.uc.edu

5135587477

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 14, 2021
• First Posted: April 23, 2021
• Study Start: June 2, 2021
• Primary Completion: October 12, 2021
• Study Completion: October 12, 2021
• Last Updated: August 21, 2024
• Results First Posted: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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

Locations

US (1)