NCT02482727

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 repair. 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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

June 22, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 26, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Last Updated

February 23, 2017

Status Verified

July 1, 2016

Enrollment Period

3 years

First QC Date

June 22, 2015

Last Update Submit

February 21, 2017

Conditions

Distal Radius FractureRehabilitation

Keywords

Blood Flow RestrictionOcclusion trainingDistal radius fracture

Outcome Measures

Primary Outcomes (1)

  • Grip strength

    grip strength measured with the JAMAR Hand Dynamometer. The mean of three successive trials will be recorded

    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

  • +1 more other outcomes

Study Arms (2)

non-occlusion training group

NO 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.

occlusion training with DELFI PTS ii tourniquet

EXPERIMENTAL

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)

Device: occlusion training with tourniquet (DELFI PTS ii portable tourniquet system)

Interventions

occlusion training with tourniquet (DELFI PTS ii portable tourniquet system)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 dopplar 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 training with DELFI PTS ii tourniquet

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Status post open reduction internal fixation for a distal radius fracture
  • Males and females 18-65 years of age
  • Eligible to receive care at Military Treatment Facilities (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.
  • 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
  • Cancer (current diagnosis per medical record)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brooke Army Medical Center

San Antonio, Texas, 78234, United States

RECRUITING

MeSH Terms

Conditions

Wrist Fractures

Interventions

Tourniquets

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Intervention Hierarchy (Ancestors)

Equipment and Supplies

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
Jill Cancio, OTD, OTR, CHT

Study Record Dates

First Submitted

June 22, 2015

First Posted

June 26, 2015

Study Start

June 1, 2015

Primary Completion

June 1, 2018

Last Updated

February 23, 2017

Record last verified: 2016-07

Locations

US(1)