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NCT05247398 · ClinicalTrials.gov registry record · Phase 2

Mechanisms of a Dynamic Stability Approach

A Phase 2 study, sponsored by University of Minnesota.

Completed
Registry status
Phase 2
Development phase
21
Enrollment target

NCT05247398: Completed Phase 2 study, sponsored by University of Minnesota.

NCT05247398 is a Phase 2 study that has completed, run by University of Minnesota. The registered enrollment target is 21 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05247398, a Phase 2 study, has completed, sponsored by University of Minnesota.

COMPLETED
Registry status
Phase 2
Development phase
21 participants
Enrollment target

Study Summary

Background. Arthritis is the leading cause of disability in the United States and osteoarthritis (OA) of the hand affects an estimated 25.6 US residents. OA of the thumb carpometacarpal (CMC) joint is the most disabling form of hand OA. Rehabilitation for persons with thumb CMC OA is recommended as the initial treatment and often involves instruction on joint protection and fitting of a splint to reduce joint stress and pain. More recently, evidence has suggested that specialized exercise may impact a factor linked to this condition, altered joint mechanics. Health records data also suggests that these exercises reduce pain and disability more than what would be experienced by those receiving standard care (SOC) rehabilitation. However, there has not yet been a prospective investigation on how these dynamic stability (DS) exercises alter joint mechanics, improve function, and reduce pain relative to standard treatment. Relatedly, thumb CMC mechanics are most often assessed by physicians through CAT scan and although rehabilitation therapists are not licensed to conduct such assessments, they could benefit from 'real-time' imaging to inform and evaluate the mechanical effects of treatment. Sonography might afford therapists the precision to evaluate mechanical response to treatment yet it is not yet known if thumb CMC sonography corresponds with the gold standard, CAT scan. Goal and Specific Aims. The long term goal this line of study is to reduce the effects of thumb CMC OA on activity performance and participation through non-invasive and non- pharmacological interventions. We expect to achieve our goals by pursuit of the following two specific aims: 1). Determine if a novel exercise regimen reduces radiographic thumb CMC joint misalignment among persons with thumb carpometacarpal osteoarthritis and 2) Evaluate the accuracy of ultrasound compared with CAT scan (reference standard) for quantifying thumb CMC subluxation Design and Methods. Specific aim 1 will be ad

Primary Outcome

CAT scan will be used at baseline and 9 weeks to obtain measurements as per the American College of Radiology's 2013 Technical Standards. A validated positioning jig reproduced by our lab will be used to maintain standardized joint positioning and standardize stress to the thumb metacarpal during fluoroscopic examination. "Joint subluxation" is a measure of thumb CMC instability and will be measured in millimeters.

Interventions

  • OTHER Dynamic Stability Exercise Program

Trial Details

FieldValue
Enrollment Target 21 participants
Start Date 2022-07-18
Est. Completion 2024-06-30
Phase Phase 2
University of Minnesota

966 total trials

What the finished NCT05247398 record still lists

NCT05247398 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower).

The record links to 0 conditions, and to 1 intervention - of which Dynamic Stability Exercise Program is the first listed.

NCT05247398 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05247398 about?

NCT05247398 is a clinical study titled "Mechanisms of a Dynamic Stability Approach". Background. Arthritis is the leading cause of disability in the United States and osteoarthritis (OA) of the hand affects an estimated 25.6 US residents. OA of the thumb carpometacarpal (CMC) joint is the most disabling form of hand OA. Rehabilitation for persons with thumb CMC OA is recommended as ...

What is the current status of trial NCT05247398?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2022-07-18. Estimated completion is 2024-06-30.

What interventions are being tested in trial NCT05247398?

The interventions under investigation include: Dynamic Stability Exercise Program (OTHER).

Who is sponsoring clinical trial NCT05247398?

This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05247398's enrollment target sits among peer trials

21 1794th of 2000 higher than 196 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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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Source: ClinicalTrials.gov NCT05247398, the US trial registry maintained by the National Library of Medicine. NCT05247398 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.