Motor Control Physical Therapist Support Stroke

NCT ID: NCT04856527

Last Updated: 2024-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-02
• Study Completion Date: 2021-10-12

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Physical therapist support

Intervention Type: BEHAVIORAL

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

Control Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

TriHealth Inc.

OTHER

Sponsor Role: collaborator

University of Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Sarah Schwab

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Cincinnati Center for Cognition, Action, and Perception

Cincinnati, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2020-1072

Identifier Type: -

Identifier Source: org_study_id