- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04856527
Motor Control Physical Therapist Support Stroke
The Motor Control Consequences of Excessive Physical Therapist Support in Individuals With Stroke
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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Ohio
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Cincinnati, Ohio, Förenta staterna, 45221
- University of Cincinnati Center for Cognition, Action, and Perception
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: 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.
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Participants will receive physical therapist support to reduce postural sway variability while completing an upper limb precision aiming task in virtual reality.
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Inget ingripande: Control Group
Participants will receive no physical therapist support while completing the task.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Center of pressure path length
Tidsram: Change from initial assessment to after 10 minutes of practice; during practice (10 minutes total)
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The amount of displacement of the location of the (resultant) vertical ground reaction force vector.
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Change from initial assessment to after 10 minutes of practice; during practice (10 minutes total)
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Standard deviation of center of pressure
Tidsram: Change from initial assessment to after 10 minutes of practice; during practice (10 minutes total)
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Variability of center of pressure trajectory for each plane.
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Change from initial assessment to after 10 minutes of practice; during practice (10 minutes total)
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Recurrence quantification analysis
Tidsram: Change from initial assessment to after 10 minutes of practice; during practice (10 minutes total)
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Quantifies the patterning, non-stationarity, and complexity of biological time series through the analysis of local recurrences in a reconstructed phase space.
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Change from initial assessment to after 10 minutes of practice; during practice (10 minutes total)
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Entropy (Sample entropy or multiscale entropy)
Tidsram: Change from initial assessment to after 10 minutes of practice; during practice (10 minutes total)
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Evaluates the predictability of the next state of a system, given what is known about the current state of a system.
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Change from initial assessment to after 10 minutes of practice; during practice (10 minutes total)
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Error (root mean square error)
Tidsram: Change from initial assessment to after 10 minutes of practice; during practice (10 minutes total)
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Deviation of laser from target; deviation of force production from target force.
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Change from initial assessment to after 10 minutes of practice; during practice (10 minutes total)
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Samarbetspartners och utredare
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Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2020-1072
Plan för individuella deltagardata (IPD)
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IPD-planbeskrivning
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