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Motor Control Physical Therapist Support Stroke

The Motor Control Consequences of Excessive Physical Therapist Support in Individuals With Stroke

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04856527
Enrollment
25
Registered
2021-04-23
Start date
2021-06-02
Completion date
2021-10-12
Last updated
2024-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

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

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.

Interventions

BEHAVIORALPhysical therapist support

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

Sponsors

TriHealth Inc.
CollaboratorOTHER
University of Cincinnati
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Center of Pressure Path Length10 minutes of practiceThe 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.
Standard Deviation of Center of PressureAfter 10 minutes of practiceVariability of center of pressure trajectory.
Percent Determinism of Postural SwayAfter 10 minutes of practiceQuantifies 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.
Entropy (Sample Entropy)After 10 minutes of practiceEvaluates 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.
Percent CorrectAfter 10 minutes of practicePercent time on target.

Countries

United States

Participant flow

Participants by arm

ArmCount
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. 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.
11
Control Group
Participants will receive no physical therapist support while completing the task.
12
Total23

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyUnable to complete experimental task20

Baseline characteristics

CharacteristicControl GroupTotalExperimental Group
Age, Continuous50.8 years
STANDARD_DEVIATION 8.4
53.7 years
STANDARD_DEVIATION 7.3
57 years
STANDARD_DEVIATION 4.3
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
12 Participants23 Participants11 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
7 Participants11 Participants4 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
5 Participants12 Participants7 Participants
Sex: Female, Male
Female
10 Participants17 Participants7 Participants
Sex: Female, Male
Male
2 Participants6 Participants4 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 110 / 12
other
Total, other adverse events
0 / 110 / 12
serious
Total, serious adverse events
0 / 110 / 12

Outcome results

Primary

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.

Time frame: 10 minutes of practice

Population: Difference between path length during practice.

ArmMeasureValue (MEAN)Dispersion
Experimental GroupCenter of Pressure Path Length98.5 cm^2Standard Error 17.5
Control GroupCenter of Pressure Path Length156.1 cm^2Standard Error 16.8
Primary

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.

Time frame: After 10 minutes of practice

Population: Post-test results

ArmMeasureValue (MEAN)Dispersion
Experimental GroupEntropy (Sample Entropy)1.2 ratio of AP:MLStandard Error 0.19
Control GroupEntropy (Sample Entropy)1.54 ratio of AP:MLStandard Error 0.18
Experimental Group: Non-Paretic LimbEntropy (Sample Entropy)1.4 ratio of AP:MLStandard Error 0.18
Control Group Non-Paretic LimbEntropy (Sample Entropy)1.1 ratio of AP:MLStandard Error 0.19
Primary

Percent Correct

Percent time on target.

Time frame: After 10 minutes of practice

Population: Post-test results

ArmMeasureValue (MEAN)Dispersion
Experimental GroupPercent Correct.66 percentage of time on targetStandard Error 0.08
Control GroupPercent Correct.74 percentage of time on targetStandard Error 0.06
Experimental Group: Non-Paretic LimbPercent Correct.95 percentage of time on targetStandard Error 0.01
Control Group Non-Paretic LimbPercent Correct.91 percentage of time on targetStandard Error 0.01
Primary

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.

Time frame: After 10 minutes of practice

Population: Post-test results

ArmMeasureValue (MEAN)Dispersion
Experimental GroupPercent Determinism of Postural Sway.99 percent determinismStandard Error 0.001
Control GroupPercent Determinism of Postural Sway.99 percent determinismStandard Error 0.001
Experimental Group: Non-Paretic LimbPercent Determinism of Postural Sway.99 percent determinismStandard Error 0.001
Control Group Non-Paretic LimbPercent Determinism of Postural Sway.99 percent determinismStandard Error 0.001
Primary

Standard Deviation of Center of Pressure

Variability of center of pressure trajectory.

Time frame: After 10 minutes of practice

Population: Post-test results from when participants were aiming with each upper limb.

ArmMeasureValue (MEAN)Dispersion
Experimental GroupStandard Deviation of Center of Pressure.70 cmStandard Error 0.06
Control GroupStandard Deviation of Center of Pressure.53 cmStandard Error 0.05
Experimental Group: Non-Paretic LimbStandard Deviation of Center of Pressure.69 cmStandard Error 0.04
Control Group Non-Paretic LimbStandard Deviation of Center of Pressure.53 cmStandard Error 0.04

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026