BFR DISTRAD NON OP: Blood Flow Restricted Training During Rehabilitation Following Distal Radius Fracture

NCT03056950 | Unknown

• 1 other identifier: C.2016.045
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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

Keywords

Blood Flow Restriciton; Occlusion training; Distal radius fracture

Outcome Measures

Primary Outcomes (1)

• grip strength

  grip strength will be assessed using the JAMAR Hand Dynamometer

  18 weeks

Secondary Outcomes (2)

• pinch strength

  18 weeks

• joint range of motion

  18 weeks

Other Outcomes (4)

• Performance measure DASH

  18 weeks

• Performance measure PRWE

  18 weeks

• Performance measure JTHFT

  18 weeks

Study Arms (2)

non-oclusion training group

NO INTERVENTION

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.

occlusion traingn with tourniquet

ACTIVE COMPARATOR

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)

Device: DELFI PTS ii portable tourniquet

Interventions

DELFI PTS ii portable tourniquet DEVICE

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.

occlusion traingn with tourniquet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Brooke Army Medical Center: lead

Study Sites (1)

Brooke Army Medical Center

San Antonio, Texas, 78234, United States

RECRUITING

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 15, 2017
• First Posted: February 17, 2017
• Study Start: March 1, 2016
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: February 20, 2017

Record last verified: 2017-02

Locations

US (1)