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

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ClinicalTrials.gov Identifier: NCT03056950
Recruitment Status : Unknown
Verified February 2017 by Jill Cancio, Brooke Army Medical Center.
Recruitment status was:  Recruiting
First Posted : February 17, 2017
Last Update Posted : February 20, 2017
Sponsor:
Information provided by (Responsible Party):
Jill Cancio, Brooke Army Medical Center

Tracking Information
First Submitted Date  ICMJE February 15, 2017
First Posted Date  ICMJE February 17, 2017
Last Update Posted Date February 20, 2017
Study Start Date  ICMJE March 2016
Estimated Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 15, 2017)
grip strength [ Time Frame: 18 weeks ]
grip strength will be assessed using the JAMAR Hand Dynamometer
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 15, 2017)
  • 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 Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 15, 2017)
  • Performance measure DASH [ Time Frame: 18 weeks ]
    a 30-item self-report measure that assesses a subject's perceived ability to complete twenty-one upper extremity functional activities using a 5-point Likert scale. The cumulative DASH score is scaled from 0 to 100, with higher scores indicating increased disability
  • Performance measure PRWE [ Time Frame: 18 weeks ]
    a 15-item questionnaire that assesses wrist pain (5 items) and disability (10 items) in activities of daily living.
  • Performance measure JTHFT [ Time Frame: 18 weeks ]
    is a seven part test that evaluates the time needed to perform seven hand-related tasks
  • Performance measure PSFS [ Time Frame: 18 weeks ]
    a patient-specific outcome measure to assess functional status[49]. The patient is asked to identify three to five activities that he or she has difficulty performing due to his or her condition. The patient then rates the amount of limitation he or she has in performing each of these activities on an 11-point scale with 0 being unable to perform the activity and 10 being able to perform the activity with no problem. An average score for the activities gives an ability score out of 10.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE BFR DISTRAD NON OP: Blood Flow Restricted Training During Rehabilitation Following Distal Radius Fracture
Official Title  ICMJE 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 Description

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; desensitization as needed; edema control as needed; heat/cold modalities as needed; and strengthening exercises. Specific strengthening exercises will include wrist flexion/extension over a foam wedge, forearm pronation/supination with arm positioned at side and elbow at 90 degrees, thumb opposition (pinch strength) as well as grip strengthening. The amount of resistance used with be determined by patient tolerance and post operative precautions.

The occlusion training group will follow the same protocol as described above but will utilize occlusion training with the strengthening exercises. We will use an established occlusion training protocol already being used at the CFI. The resistance for strength training will be determined based on the individual participants tolerance. 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 dopplar ultrasound over the radial artery at the wrist level) at the first scheduled therapy visit. Limb occlusion pressure is the pressure necessary to completely occlude arterial blood flow. The cuff pressure utilized during the post-operative exercises will be set at 50% of the limb occlusion pressure. Repetions will be 30, 15, 15 and 15 for each of the four sets. A 30-second rest will be given between sets. The tourniquet will stay inflated throughout the entire exercise and rest sessions, and no longer than 30 minutes consecutively for any time that the tourniquet is inflated. After completion of the 4 sets the tourniquet pressure will be deflated. The subjects' strength will be re-assessed approximately every 2-4 weeks and the load will be increased as tolerated.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Distal Radius Fracture
  • Rehabilitation
Intervention  ICMJE Device: 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.
Study Arms  ICMJE
  • 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)
    Intervention: Device: DELFI PTS ii portable tourniquet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 15, 2017)
52
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2019
Estimated Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03056950
Other Study ID Numbers  ICMJE C.2016.045
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Jill Cancio, Brooke Army Medical Center
Study Sponsor  ICMJE Brooke Army Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Brooke Army Medical Center
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP