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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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.

Detailed Summary:

Investigator's will perform a prospective, randomized, controlled study. All subjects in this group will be adults who have sustained a distal radius fractured treated with cast immobilization (non-operative) at San Antonio Military Medical Center (SAMMC) clinic system. Participants will be provided information about the study and inclusion/exclusion criteria, and upon conclusion of the formal consenting process, and signature of the consent document, will be considered enrolled in the study. Prior to intiation of any study procedures each patient must be cleared for participation in treatment by his or her surgeon as per standard post-fracture protocol. Medical clearance will be documented on the Enrollment form (Appendix A) and the Medical History form (Appendix K). This will be verified by accessing the medical record to confirm that a referral was made for post-fracture rehabilitation. Before initiation of treatment, the enrolled subjects will be randomized to either a standard rehabilitation group or an occlusion training rehabilitation group. Randomization with be performed with a random number generator. Treatment will be initiated approxmiately 6 weeks s/p fracture (when cleared by the orthopedic surgeon). Participantswill undergo approximetely 8-12 weeks of treatment with therapy sessions two to three days a week (consistent with standard of care), and will have re-assessments completed at approximately 4 weeks, 8 weeks, and 12 weeks after initiating the training protocol. The 12-week time point (after initiation of therapy) will be at approximately the same time that patients are released for full activity per standard of care.

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; desens
Sponsor: Brooke Army Medical Center

Current Primary Outcome: grip strength [ Time Frame: 18 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• pinch strength [ Time Frame: 18 weeks ]
  Pinch strength will be assessed using the PG-60 Pinch Gauge. The mean of three successive trials will be recorded for each pinch position (tip, key and palmar)
• joint range of motion [ Time Frame: 18 weeks ]
  Joint range of motion (ROM) will be assessed using a plastic goniometer

Original Secondary Outcome: Same as current

Information By: Brooke Army Medical Center

Dates:
Date Received: February 15, 2017
Date Started: March 2016
Date Completion: March 2019
Last Updated: February 16, 2017
Last Verified: February 2017