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NCT06136286 · ClinicalTrials.gov registry record · NA

ORIF Distal Radius Blood Flow Restriction Therapy

A NA study of Distal Radius Fractures, sponsored by The Methodist Hospital Research Institute.

Active
Registry status
NA
Development phase
70
Enrollment target
1
Study location

NCT06136286: Active NA study of Distal Radius Fractures, sponsored by The Methodist Hospital Research Institute.

NCT06136286 is a NA study of Distal Radius Fractures that is active but no longer recruiting, run by The Methodist Hospital Research Institute. The registered enrollment target is 70 participants, below the 179-participant average among 4 other Distal Radius Fractures trials with a reported enrollment target (61% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06136286, a NA study of Distal Radius Fractures, is active but no longer recruiting, sponsored by The Methodist Hospital Research Institute.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
70 participants
Enrollment target
1
Study location

Study Summary

Patients commonly experience a significant amount of muscular atrophy following open reduction internal fixation (ORIF) surgery of distal radius fractures, associated with an increased risk of re-injury, and an increase in time of recovery. A combination of low intensity resistance exercise and blood flow restriction (BFR) therapy has been shown to elicit responses similar to high intensity resistance exercise with reduced risk. We hypothesize that chronic low intensity resistance exercise combined with BFR will improve muscular strength, reduce skeletal muscle atrophy, and will enhance recovery. Therefore, the specific aims of this study are as follows: 1. Determine if BFR added to standard post-operative rehab will prevent skeletal muscle atrophy and promote skeletal muscle growth during 12-weeks of rehab training compared to traditional rehab alone. The working hypothesis, founded on previous literature, is that combined rehab and BFR will enhance skeletal muscle growth and prevent atrophy to a greater extent than rehab alone. 2. Determine if BFR added to standard post-operative rehab will improve muscular strength following surgery compared to traditional rehab alone. Because strength can be attributed to skeletal muscle mass, the working hypothesis, founded on previous literature, is that combined rehab and BFR will enhance skeletal muscle strength and fatigue resistance to a greater extent than rehab alone. 3. Determine if BFR added to standard post-operative rehab will improve functional outcomes following surgery compared to traditional rehab alone. The working hypothesis, founded on previous literature is that BFR will improve functional outcomes over rehab alone.

Primary Outcome

Soft tissue analysis of forearm and total body via DEXA scan.

Conditions Studied

Interventions

  • DEVICE Blood Flow Restriction (BFR) Cuff

Study Locations (1)

Texas

  • Houston Methodist Hospital - Houston

Trial Details

FieldValue
Enrollment Target 70 participants
Start Date 2019-10-22
Est. Completion 2027-01-01
Phase NA

What the registry record for NCT06136286 still lists

NCT06136286 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 179-participant average among 4 other Distal Radius Fractures trials with a reported enrollment target (61% lower).

The record links to 1 condition, with Distal Radius Fractures appearing as the primary indexed condition, and to 1 intervention - of which Blood Flow Restriction (BFR) Cuff is the first listed.

NCT06136286 reports a single indexed study location in Texas.

Frequently Asked Questions

What is clinical trial NCT06136286 about?

NCT06136286 is a clinical study titled "ORIF Distal Radius Blood Flow Restriction Therapy". Patients commonly experience a significant amount of muscular atrophy following open reduction internal fixation (ORIF) surgery of distal radius fractures, associated with an increased risk of re-injury, and an increase in time of recovery. A combination of low intensity resistance exercise and bloo...

What is the current status of trial NCT06136286?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 70 participants. The study started on 2019-10-22. Estimated completion is 2027-01-01.

What conditions does trial NCT06136286 study?

This clinical trial studies the following conditions: Distal Radius Fractures.

What interventions are being tested in trial NCT06136286?

The interventions under investigation include: Blood Flow Restriction (BFR) Cuff (DEVICE).

Who is sponsoring clinical trial NCT06136286?

This trial is sponsored by The Methodist Hospital Research Institute, which has 126 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06136286 being conducted?

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

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Source: ClinicalTrials.gov NCT06136286, the US trial registry maintained by the National Library of Medicine. NCT06136286 (small enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.