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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04856527
Other study ID # 2020-1072
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 2, 2021
Est. completion date October 12, 2021

Study information

Verified date April 2022
Source University of Cincinnati
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date October 12, 2021
Est. primary completion date October 12, 2021
Accepts healthy volunteers No
Gender All
Age group 40 Years to 75 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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.

Locations

Country Name City State
United States University of Cincinnati Center for Cognition, Action, and Perception Cincinnati Ohio

Sponsors (2)

Lead Sponsor Collaborator
University of Cincinnati TriHealth Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Center of pressure path length The amount of displacement of the location of the (resultant) vertical ground reaction force vector. Change from initial assessment to after 10 minutes of practice; during practice (10 minutes total)
Primary Standard deviation of center of pressure Variability of center of pressure trajectory for each plane. Change from initial assessment to after 10 minutes of practice; during practice (10 minutes total)
Primary 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. Change from initial assessment to after 10 minutes of practice; during practice (10 minutes total)
Primary 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. Change from initial assessment to after 10 minutes of practice; during practice (10 minutes total)
Primary Error (root mean square error) Deviation of laser from target; deviation of force production from target force. Change from initial assessment to after 10 minutes of practice; during practice (10 minutes total)
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