Recruiting

BFR Training

Sponsor:

Brooke Army Medical Center

Code:

NCT03056950

Conditions

Distal Radius Fracture

Rehabilitation

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

DELFI PTS ii portable tourniquet

Study Details

Brief summary:

Occlusion training, resistance exercise performed with a specialized venous tourniquet, leads to beneficial changes in muscle strength at low resistance and minimal stress on the nearby joint. This novel resistance training has the potential to greatly improve muscle strength gains in individuals who are unable, for medical reasons, to perform the high resistance exercises typically required to improve strength. Our study will examine the effect of this technique on strength recovery following distal radius fracture treated with cast immobilization (non-operatively). The primary objective of the intervention is to achieve accelerated recovery of forearm, wrist and hand function as assessed using measures such as grip/pinch strength, validated questionnaires, and functional outcome testing. Occlusion training can potentially serve as a specialty intervention for rehabilitation patients, reduce the cost of care, and improve the treatment options for both patients and providers.

Conditions

Distal Radius Fracture

Rehabilitation

Study ID

NCT03056950

Start date

Mar, 2016

Status verified date

Feb, 2017

Completion date

Mar, 2019

Anticipated

Primary completion date

Mar, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Status post distal radius fracture (non-operative treated with cast immobilization)
  • Males and females 18-65 years of age
  • Eligible to receive care at Military Treatment Facility (DEERS eligible)
  • Must be able to read and write in English in order to consent

Exclusion Criteria:

  • Contralateral upper extremity involvement resulting in less than normal range of motion, muscle strength, or daily pain greater than 1/10.
  • Status post distal radius fractured treated operatively (k-wires, ORIF, etc)
  • Pregnancy - per patient self-report. Due the expected small number of pregnant individuals and resulting inability to account for its effect on resulting outcomes, these patients will not be included in the study.
  • Recent history of deep vein thrombosis, within the 12 months or on active treatment with anticoagulants
  • History of upper quadrant lymph node dissection
  • History of endothelial dysfunction
  • Patient endorsement of easy bruising
  • Active Infection in the injured arm
  • Cancer (current diagnosis per medical record)

Study Design

Enrollment

52 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: non-oclusion training group

The control (non-occlusion training) group will follow the standard s/p 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.

active comparator: occlusion traingn with tourniquet

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 used. Intervention: Occlusion training with tourniquet (DELFI PTS ii portable tourniquet system)

Interventions

DELFI PTS ii portable tourniquet

A cuff will be wrapped around the most proximal portion of the arm of the involved extremity. In order to individualize the pressure for each subject, the limb occlusion pressure will be measured (with doppler ultrasound over the radial artery at the wrist level) at the first scheduled therapy visit. The cuff pressure utilized during the post-operative exercises will be set at 50% of the limb occlusion pressure. The subjects' strength will be re-assessed approximately every 2-4 weeks and the load will be increased as tolerated.

Primary outcome measure

  • grip strength [ Time Frame: 18 weeks ]

Central Contacts and Locations

Locations

Brooke Army Medical Center

Recruiting

San Antonio, Texas, United States, 78234

Contacts

Simon A Brown, MBA

210-965-8634simon.a.brown.ctr@mail.mil

Jason M Wilken, PhD

210-916-1478jason.m.wilken.civ@mail.mil

Principal Investigator:

Jill Cancio, OTD

More Information

Sponsor

Brooke Army Medical Center

Last update posted

Feb 20, 2017

Last verified

Feb, 2017

Keywords

  • Blood Flow Restriciton
  • Occlusion training
  • Distal radius fracture

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Brooke Army Medical Center on 2017-02-20.