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NCT03203291 · ClinicalTrials.gov registry record · NA
Reducing Asymmetry During Gait Using the TPAD (Tethered Pelvic Assist Device) for Stroke Patients
A NA study, sponsored by Columbia University.
- Completed
- Registry status
- NA
- Development phase
- 12
- Enrollment target
NCT03203291: Completed NA study, sponsored by Columbia University.
NCT03203291 is a NA study that has completed, run by Columbia University. The registered enrollment target is 12 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03203291, a NA study, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- NA
- Development phase
- 12 participants
- Enrollment target
Study Summary
OBJECTIVES: The purpose of this study is to evaluate the overall feasibility in terms of safety, treatment tolerance and adherence as well as preliminarily address how effective this treatment model using the TPAD and overground training would be to reduce load asymmetry on the treadmill and promote increased stance symmetry on the paretic limb during overground gait.PARTICIPANTS: A total of 12 individuals in the chronic (\>6 months) stages post stroke will be recruited from a voluntary stroke research database for participation. DESIGN: A non-randomized pilot study of feasibility will be used to establish the feasibility and preliminary efficacy of using the TPAD in combination with overground training to reduce load force asymmetry in this population. METHODS: Participants will undergo a series of three assessments within a one-week time frame prior to initiating intervention. Intervention using the TPAD and overground training will occur during week 2 over 5 consecutive visits (Mon-Fri). Participants will also complete short walks before and after the intervention with an instrumented system that records individual walking characteristics. Participants will return one-week after completing the intervention for a final test of walking and balance. Each study visit will be approximately 1-1.5 hours in duration, and total participation should be completed within three weeks. EXPECTED OUTCOMES: We anticipate this training paradigm will prove feasible and effective in reducing both load and stance asymmetry in a population of individuals with chronic stroke.
Primary Outcome
0-1 symmetry ratio comparing the impulse force of the affected limb versus the unaffected limb during gait. If the unaffected limb performs equivalent to the affected limb, the ratio has a value of 1. The greater the disparity between limbs, the closer the ratio is to 0.
Interventions
- DEVICE TPAD (Tethered Pelvic Assist Device)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2017-04-01 |
| Est. Completion | 2018-05-01 |
| Phase | NA |
What the finished NCT03203291 record still lists
NCT03203291 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which TPAD (Tethered Pelvic Assist Device) is the first listed.
NCT03203291 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03203291 about?
NCT03203291 is a clinical study titled "Reducing Asymmetry During Gait Using the TPAD (Tethered Pelvic Assist Device) for Stroke Patients". OBJECTIVES: The purpose of this study is to evaluate the overall feasibility in terms of safety, treatment tolerance and adherence as well as preliminarily address how effective this treatment model using the TPAD and overground training would be to reduce load asymmetry on the treadmill and promote...
What is the current status of trial NCT03203291?
This trial is currently completed. It is a NA study. The enrollment target is 12 participants. The study started on 2017-04-01. Estimated completion is 2018-05-01.
What interventions are being tested in trial NCT03203291?
The interventions under investigation include: TPAD (Tethered Pelvic Assist Device) (DEVICE).
Who is sponsoring clinical trial NCT03203291?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03203291's enrollment target sits among peer trials
12 1913th of 2000 higher than 74 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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