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Behavioural Intervention

Blood Flow Restriction Therapy for Wrist Fractures (BFR DISTRAD Trial)

N/A

Waitlist Available

Research Sponsored by Brooke Army Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Status post open reduction internal fixation for a distal radius fracture

Males and females 18-65 years of age

Must not have

Recent history of deep vein thrombosis, within the 12 months or on active treatment with anticoagulants

Contralateral upper extremity involvement resulting in less than normal range of motion, muscle strength, or daily pain greater than 1/10

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 week

Awards & highlights

No Placebo-Only Group

Summary

This trial will examine the effect of occlusion training on strength recovery following distal radius fracture repair, with the goal of accelerated recovery of forearm, wrist, and hand function.

Who is the study for?

This trial is for men and women aged 18-65 who've had surgery to fix a broken wrist (distal radius fracture) and can get care at Military Treatment Facilities. They must be able to read and write in English. People with movement issues in the other arm, pregnant individuals, recent deep vein thrombosis, history of lymph node removal or endothelial dysfunction, easy bruising, active infection or current cancer are excluded.

What is being tested?

The study tests blood flow restricted training using a tourniquet during rehab after wrist fracture surgery. The goal is to see if this method helps patients regain strength faster in their forearm, wrist, and hand compared to standard rehab exercises.

What are the potential side effects?

While not explicitly listed in the provided information, potential side effects may include discomfort from the tourniquet pressure, temporary numbness or tingling in the limb due to restricted blood flow during exercise sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I had surgery to fix a broken wrist with plates and screws.

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I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a blood clot in the last year or am on blood thinners.

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I have issues with my opposite arm affecting movement, strength, or daily pain over 1/10.

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I do not have any current infections.

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I have had surgery to remove lymph nodes in the upper part of my body.

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I have been diagnosed with cancer.

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I have a history of blood vessel problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 week

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 week

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 week for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Grip strength

Secondary study objectives

Joint range of motion

Pinch strength

Other study objectives

Performance measure DASH

Performance measure JTHFT

Performance measure PRWE

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: occlusion training with DELFI PTS ii tourniquetExperimental Treatment1 Intervention

The occlusion training group will follow the same protocol as described above but will utilize occlusion training with the strengthening exercises. Investigators will use an established occlusion training protocol already being. Intervention: occlusion training with tourniquet (DELFI PTS ii portable tourniquet system)

Group II: non-occlusion training groupActive Control1 Intervention

The control (non-occlusion training) group will follow the standard post-operative distal radius fracture rehabilitation protocol. Treatment will include passive, active assistive,active range of motion (P/AA/AROM) to wrist, forearm and hand; desensitization as needed; edema control as needed; heat/cold modalities as needed; and strengthening exercises.

0 / 8Eligibility criteria met