StrokeNCT04856527
Motor Control Physical Therapist Support Stroke
A study testing Physical therapist support in people with Stroke, run by University of Cincinnati at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Stroke
- What is being tested?
- Physical therapist support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jun 2021to 12 Oct 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Cincinnati Center for Cognition, Action, and Perception
Cincinnati, Ohio, 45221
About this study
Official title: The Motor Control Consequences of Excessive Physical Therapist Support in Individuals With Stroke
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.
Read the 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
- Being tested
- Physical therapist support
- Keywords
- physical therapy, postural control, supra-postural task, stroke, motor control, contextual factors, variability
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical therapist supportBehavioural
Participants will receive physical therapist support to reduce postural sway variability while completing an upper limb precision aiming task in virtual reality.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Physical therapist support |
| Control Group | No intervention | Participants will receive no physical therapist support while completing the task. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 minutes of practice
Standard Deviation of Center of Pressure
Variability of center of pressure trajectory.
Measured: 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.
Measured: 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.
Measured: After 10 minutes of practice
Percent Correct
Percent time on target.
Measured: After 10 minutes of practice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2021
- Study start2 Jun 2021
- Primary completion12 Oct 2021
- Study completion12 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- TriHealth Inc.
- Responsible party
- Principal investigator, Sarah Schwab, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04856527
- Sponsor's protocol ID
- 2020-1072
- Status last verified
- Aug 2024
- First submitted
- 14 Apr 2021
- Last updated
- 21 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Analytic code and other study materials may be shared on PI's Open Science Framework (OSF) page.
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Motor Control Consequences of Excessive Physical Therapist Support in Individuals With Stroke
- ClinicalTrials.gov ID
- NCT04856527
- Acronym / sponsor ID
- 2020-1072
- Conditions
- Stroke
- Keywords
- physical therapy, postural control, supra-postural task, stroke, motor control, contextual factors, variability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- TriHealth Inc.
- Study start
- 2 Jun 2021 (actual)
- Primary completion
- 12 Oct 2021 (actual)
- Study completion
- 12 Oct 2021 (actual)
- First posted
- 23 Apr 2021 (actual)
- Results
- Posted 21 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Physical therapist supportParticipants 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. |
| Control Group | No intervention | –Participants will receive no physical therapist support while completing the task. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical therapist supportParticipants will receive physical therapist support to reduce postural sway variability while completing an upper limb precision aiming task in virtual reality. | Behavioural | Experimental Group |
Primary outcome
Center of Pressure Path Length
Time frame: 10 minutes of practice
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.
Standard Deviation of Center of Pressure
Time frame: After 10 minutes of practice
Variability of center of pressure trajectory.
Percent Determinism of Postural Sway
Time frame: After 10 minutes of practice
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.
Entropy (Sample Entropy)
Time frame: After 10 minutes of practice
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.
Percent Correct
Time frame: After 10 minutes of practice
Percent time on target.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Analytic code and other study materials may be shared on PI's Open Science Framework (OSF) page.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical therapist support in people with Stroke, run by University of Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Center of Pressure Path Length (time frame: 10 minutes of practice). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024.