N/A
N=25
Motor Control Physical Therapist Support Stroke
Stroke
Bottom Line
View on ClinicalTrials.gov: NCT04856527 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: Center of Pressure Path Length — 98.5; 156.1 cm^2
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Physical therapist support (Behavioral)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- University of Cincinnati
- Primary completion
- Oct 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Center of Pressure Path Length |
98.5; 156.1 | — |
| PRIMARY Standard Deviation of Center of Pressure |
.70; .53; .69; .53 | — |
| PRIMARY Percent Determinism of Postural Sway |
.99; .99; .99; .99 | — |
| PRIMARY Entropy (Sample Entropy) |
1.2; 1.54; 1.4; 1.1 | — |
| PRIMARY Percent Correct |
.66; .74; .95; .91 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04856527). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.