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NCT07173088 · ClinicalTrials.gov registry record · NA

Efficacy and Clinical Feasibility of the Ankle Muscle Power (AMP) Program for Return to Duty After an Ankle Fracture

A NA study of Ankle Fractures, sponsored by Brian W. Noehren.

Recruiting
Registry status
NA
Development phase
60
Enrollment target
1
Study location

NCT07173088 is a NA study of Ankle Fractures that is actively recruiting participants, run by Brian W. Noehren. The registered enrollment target is 60 participants, below the 248-participant average among 12 other Ankle Fractures trials with a reported enrollment target (76% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT07173088, a NA study of Ankle Fractures, is actively recruiting participants, sponsored by Brian W. Noehren.

RECRUITING
Registry status
NA
Development phase
60 participants
Enrollment target
1
Study location

Study Summary

The goal of this clinical trial is to compare two different standardized physical therapy rehabilitation programs on outcomes after an ankle fracture. Researchers will evaluate to see if the addition of ankle muscle power exercises (AMP) improve program adherence, muscle function, physical performance, and patient reported outcomes. The main questions it aims to answer are: 1. Assess feasibility and define the initial effects of the AMP program on ankle plantar flexor rate of torque development and ankle power. Primary hypothesis: an ankle muscle power program will have acceptable feasibility through assessment of 80% adherence, 90% treatment fidelity, recruitment (48 participants who complete the study), 80% retention, and 80% acceptability of the AMP program to facilitate clinical translation and the ability to scale-up the treatment. In addition ankle plantar flexor muscle power, plantar flexor RTD assessed isometrically, and ankle joint power, evaluated during gait and stair ascent/descent, will have significantly greater improvements in the AMP group than the standard of care group at the end of the intervention. 2. Test the effect of the AMP program on physical performance. Primary hypothesis: those completing the AMP program will have greater improvements in the 40 meter fast paced walk test and 11-stair climb test than those completing standard of care at the completion of the intervention. 3. Assess the preliminary efficacy of the AMP program on patient reported outcomes and quality of life. Primary hypothesis: compared to standard of care, the AMP program will result in improved quality of life on the ankle fracture outcome rehabilitation measure (A-FORM) Participants will complete rehabilitation and be assessed for outcomes at baseline and after completing the intervention. Additionally exploratory outcomes will be assessed 3 months after completing the intervention.

Conditions Studied

Interventions

  • BEHAVIORAL Standard of Care
  • OTHER Ankle Muscle Power (AMP) program

Study Locations (1)

Kentucky

  • University of Kentucky - Lexington

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2025-11-13
Est. Completion 2028-03
Phase NA

Sponsor

Brian W. Noehren

3 total trials

What the Registry Record Tells You About NCT07173088

The ClinicalTrials.gov registry entry for NCT07173088 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 248-participant average among 12 other Ankle Fractures trials with a reported enrollment target (76% lower). The listed sponsor is Brian W. Noehren, which has 3 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Ankle Fractures appearing as the primary indexed condition, and to 2 interventions - of which Standard of Care is the first listed.

NCT07173088 reports 1 study location spanning 1 distinct geographic area - top geographies include Kentucky.

Frequently Asked Questions

What is clinical trial NCT07173088 about?

NCT07173088 is a clinical study titled "Efficacy and Clinical Feasibility of the Ankle Muscle Power (AMP) Program for Return to Duty After an Ankle Fracture". The goal of this clinical trial is to compare two different standardized physical therapy rehabilitation programs on outcomes after an ankle fracture. Researchers will evaluate to see if the addition of ankle muscle power exercises (AMP) improve program adherence, muscle function, physical performan...

What is the current status of trial NCT07173088?

This trial is currently recruiting. It is a NA study. The enrollment target is 60 participants. The study started on 2025-11-13. Estimated completion is 2028-03.

What conditions does trial NCT07173088 study?

This clinical trial studies the following conditions: Ankle Fractures.

What interventions are being tested in trial NCT07173088?

The interventions under investigation include: Standard of Care (BEHAVIORAL), Ankle Muscle Power (AMP) program (OTHER).

Who is sponsoring clinical trial NCT07173088?

This trial is sponsored by Brian W. Noehren, which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07173088 being conducted?

This trial has 1 study location across Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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