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NCT02634814 · ClinicalTrials.gov registry record · NA
The KNEEhabilitation Study: Improving Disability in Individuals With Knee Osteoarthritis
A NA study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- NA
- Development phase
- 90
- Enrollment target
NCT02634814 is a NA study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 90 participants.
The verdict
NCT02634814, a NA study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- NA
- Development phase
- 90 participants
- Enrollment target
Study Summary
The focus of this project is to use transcutaneous electrical nerve stimulation (TENS) for the novel indication of treating neuromuscular activation in individuals with knee osteoarthritis (OA) that exhibit neuromuscular activation deficits. The overall goal is to improve outcomes associated traditional therapeutic exercise (TE) by developing an enhanced rehabilitation strategy, which augments TE with TENS (TENS+TE), for the purpose of treating underlying neuromuscular activation deficits. The investigators seek to use TENS to excite neural pathways that immediately increase neuromuscular activation as well as cause sustained improvements in neuromuscular activation and greater strength gains in knee OA patients compared to traditional TE. The investigators will evaluate the effect of TENS+TE on muscle strength, neuromuscular activation, gait biomechanics, physical function, physical activity, self-efficacy of physical activity, self-reported quality of life, disability and pain. The central hypothesis is that an enhanced TENS+TE intervention will lead to better clinical outcomes, increased physical activity, and improved general health. The rationale for conducting a small clinical trial, which demonstrates the feasibility and establishes the preliminary effects of an enhanced rehabilitation strategy, is ultimately to inform the development of a future larger clinical trial to establish the efficacy of an enhanced rehabilitation strategy for knee OA. This hypothesis will be tested through two specific aims: 1) to collect and report data on the feasibility of conducting a clinical trial to evaluate the efficacy of using TENS+TE compared to sham TENS+TE and to TE only for treating patients with knee OA in a clinical setting, and 2) to determine preliminary effects of a 4-week TENS+TE intervention compared to sham TENS+TE, and TE only on muscle strength, neuromuscular activation, gait biomechanics, physical function, physical activity, self-efficacy of physical activi
Interventions
- DEVICE Transcutaneous Electrical Nerve Stimulation
- OTHER Therapeutic Exercise
- DEVICE Sham Transcutaneous Electrical Nerve Stimulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2015-10 |
| Est. Completion | 2017-11-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02634814
The ClinicalTrials.gov registry entry for NCT02634814 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Transcutaneous Electrical Nerve Stimulation is the first listed.
NCT02634814 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02634814 about?
NCT02634814 is a clinical study titled "The KNEEhabilitation Study: Improving Disability in Individuals With Knee Osteoarthritis". The focus of this project is to use transcutaneous electrical nerve stimulation (TENS) for the novel indication of treating neuromuscular activation in individuals with knee osteoarthritis (OA) that exhibit neuromuscular activation deficits. The overall goal is to improve outcomes associated traditi...
What is the current status of trial NCT02634814?
This trial is currently completed. It is a NA study. The enrollment target is 90 participants. The study started on 2015-10. Estimated completion is 2017-11-01.
What interventions are being tested in trial NCT02634814?
The interventions under investigation include: Transcutaneous Electrical Nerve Stimulation (DEVICE), Therapeutic Exercise (OTHER), Sham Transcutaneous Electrical Nerve Stimulation (DEVICE).
Who is sponsoring clinical trial NCT02634814?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
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