BFR DISTRAD: Blood Flow Restricted Training During Rehabilitation Following Distal Radius Fracture Repair
| Status: | Recruiting |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 7/20/2016 |
| Start Date: | June 2015 |
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.
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.
Investigators will perform a prospective, randomized, controlled study. All subjects in this
group will be adults having undergone an open reduction internal fixation of the distal
radius 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 initiation of any study procedures each patient must be
cleared for participation in treatment by his or her surgeon as per standard post-operative
protocol. This will be verified by accessing the medical record to confirm that a referral
was made for post-operative rehabilitation. Before initiation of treatment, the enrolled
subjects will be randomized to either a standard rehabilitation group or an occlusion
training rehabilitation group. Treatment will be initiated approximately 6 weeks after
surgery (when cleared by the orthopedic surgeon). Participants will undergo approximately
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 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.
Specific strengthening exercises which include wrist flexion/extension over a foam wedge,
forearm pronation/supination with arm positioned at side and elbow at 90 degrees, thumb
opposition as well as grip strengthening.
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 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. The cuff pressure utilized during the post-operative exercises will
be set at 50% of the limb occlusion pressure. Repetitions 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.
group will be adults having undergone an open reduction internal fixation of the distal
radius 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 initiation of any study procedures each patient must be
cleared for participation in treatment by his or her surgeon as per standard post-operative
protocol. This will be verified by accessing the medical record to confirm that a referral
was made for post-operative rehabilitation. Before initiation of treatment, the enrolled
subjects will be randomized to either a standard rehabilitation group or an occlusion
training rehabilitation group. Treatment will be initiated approximately 6 weeks after
surgery (when cleared by the orthopedic surgeon). Participants will undergo approximately
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 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.
Specific strengthening exercises which include wrist flexion/extension over a foam wedge,
forearm pronation/supination with arm positioned at side and elbow at 90 degrees, thumb
opposition as well as grip strengthening.
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 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. The cuff pressure utilized during the post-operative exercises will
be set at 50% of the limb occlusion pressure. Repetitions 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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
We found this trial at
1
site
San Antonio, Texas 78234
Principal Investigator: Jill Cancio, OTD
Phone: 210-965-8634
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