AzTrials
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Limb InjuryRapidRehabNCT03446131

Improved Training Program for Fall Prevention of War Fighters

An observational study of Limb Injury, run by Mayo Clinic at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will train War Fighters with lower extremity trauma to decrease fall risk. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Limb Injury
How many people
45 participants
Where
4 sitesUnited States
Study dates
12 Mar 2018to 31 Dec 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Study population: This study plans to recruit both male and female military beneficiaries with a unilateral or bilateral transtibial or transfemoral amputation or salvaged and preserved limbs. The subjects will be present or past patients in the Naval Medical Center San Diego, C5 Rehabilitation Program, Center for the Intrepid Rehabilitation Program or Walter Reed National Military Medical Center Rehabilitation Program. Subjects will be contacted by the respective site study coordinator and asked to participate in the study.

Who may be able to join

  • Eligible active duty and retired service members and veterans with lower limb trauma
  • Transfemoral amputation, transtibial amputation, bilateral amputation and or limb salvage
  • Participated in conventional rehab at one of the following rehab centers: Walter Reed National Medical Center, Center for the Intrepid Brooke Army Medical Center, Naval Medical Center San Diego
  • Community ambulator
  • Prosthesis / Orthosis use daily

Who cannot join

  • Dysvascular disease
  • Excessive pain
  • Neuromuscular problems preventing the performance of study protocol

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Walter Reed National Military Medical Center

    Bethesda, Maryland, 20889

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

  • Center for the Intrepid Brooke Army Medical Center

    San Antonio, Texas, 78234

  • Naval Medical Center San Diego

    San Diego, California, 92134

Other trials in United States

About this study

Official title: Improved Training Program for Fall Prevention of War Fighters With Lower Extremity Trauma

This study will train War Fighters with lower extremity trauma to decrease fall risk.

Read the detailed description

Eligible active duty service members, retired or veterans who participated in rehabilitation programs at Department of Defense Advanced Rehabilitation Centers (Walter Reed National Military Medical Center, Center for the Intrepid-San Antonio Military Medical Center and/or the Naval Medical Center San Diego) will be considered for enrollment in this study. This study will look at service members who have undergone transfemoral, transtibial or bilateral lower extremity amputation or limb salvage procedures. Participants will receive fall prevention training on an instrumented treadmill (6, training sessions). Participants will receive three performance assessments:-immediately following completion of the treadmill training and at three and six months following the completion of the training. Post training, twice per month subjects will receive an email containing a follow up fall questionnaire monitoring if they have fallen and the circumstances surrounding their fall. If they do not have access to email, or if a timely response is not received from the email questionnaire which was sent out, subjects will be contacted by phone.

Conditions
Limb Injury
Keywords
transfemoral amputation, limb salvage, bilateral amputation, Department of Defense, orthosis, prosthesis, rehabilitation, military treatment facilities, military, injured lower extremity, prevent falls, trauma lower extremity, service members, retired service members, active service members, unilateral lower extremity trauma, limb amputation, limb preservation, preserved limb, trips

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Trunk Position

    Trunk Position (referenced to vertical) at recovery step completion

    Measured: Change from baseline at 0, 3, and 6 months after completing training

  2. Change in Trunk Velocity

    Trunk Velocity at recovery step completion

    Measured: Change from baseline at 0, 3, and 6 months after completing training

Secondary outcomes (2)

  1. Falls

    Falls per month reported in the Prosthesis Evaluation Questionnaire - Addendum

    Measured: Change from baseline at 0, 3, and 6 months after completing training

  2. FSST

    Four-Square Step Test

    Measured: Change from baseline at 0, 3, and 6 months after completing training

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2018
  2. Study start12 Mar 2018
  3. Primary completion30 Sep 2020
  4. Study completion31 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03446131
Sponsor's protocol ID
RRII
Other IDs
W81XWH-15-2-0071
Acronym
RapidRehab
Status last verified
Jan 2021
First submitted
11 Dec 2017
Last updated
7 Jan 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Armed Forces Health Surveillance Center (AFHSC). Medical evacuations from Operation Iraqi Freedom/Operation New Dawn, active and reserve components, U.S. Armed Forces, 2003-2011. MSMR. 2012 Feb;19(2):18-21.

    PubMed 22372753

  • Doukas WC, Hayda RA, Frisch HM, Andersen RC, Mazurek MT, Ficke JR, Keeling JJ, Pasquina PF, Wain HJ, Carlini AR, MacKenzie EJ. The Military Extremity Trauma Amputation/Limb Salvage (METALS) study: outcomes of amputation versus limb salvage following major lower-extremity trauma. J Bone Joint Surg Am. 2013 Jan 16;95(2):138-45. doi: 10.2106/JBJS.K.00734.

    PubMed 23324961

  • Gooday HM, Hunter J. Preventing falls and stump injuries in lower limb amputees during inpatient rehabilitation: completion of the audit cycle. Clin Rehabil. 2004 Jun;18(4):379-90. doi: 10.1191/0269215504cr738oa.

    PubMed 15180121

  • Pauley T, Devlin M, Heslin K. Falls sustained during inpatient rehabilitation after lower limb amputation: prevalence and predictors. Am J Phys Med Rehabil. 2006 Jun;85(6):521-32; quiz, 533-5. doi: 10.1097/01.phm.0000219119.58965.8c.

    PubMed 16715022

  • Miller WC, Deathe AB, Speechley M, Koval J. The influence of falling, fear of falling, and balance confidence on prosthetic mobility and social activity among individuals with a lower extremity amputation. Arch Phys Med Rehabil. 2001 Sep;82(9):1238-44. doi: 10.1053/apmr.2001.25079.

    PubMed 11552197

  • Hausdorff JM, Rios DA, Edelberg HK. Gait variability and fall risk in community-living older adults: a 1-year prospective study. Arch Phys Med Rehabil. 2001 Aug;82(8):1050-6. doi: 10.1053/apmr.2001.24893.

    PubMed 11494184

  • Hornbrook MC, Stevens VJ, Wingfield DJ, Hollis JF, Greenlick MR, Ory MG. Preventing falls among community-dwelling older persons: results from a randomized trial. Gerontologist. 1994 Feb;34(1):16-23. doi: 10.1093/geront/34.1.16.

    PubMed 8150304

  • Dite W, Connor HJ, Curtis HC. Clinical identification of multiple fall risk early after unilateral transtibial amputation. Arch Phys Med Rehabil. 2007 Jan;88(1):109-14. doi: 10.1016/j.apmr.2006.10.015.

    PubMed 17207685

  • Franchignoni F, Orlandini D, Ferriero G, Moscato TA. Reliability, validity, and responsiveness of the locomotor capabilities index in adults with lower-limb amputation undergoing prosthetic training. Arch Phys Med Rehabil. 2004 May;85(5):743-8. doi: 10.1016/j.apmr.2003.06.010.

    PubMed 15129398

  • van Velzen JM, van Bennekom CA, Polomski W, Slootman JR, van der Woude LH, Houdijk H. Physical capacity and walking ability after lower limb amputation: a systematic review. Clin Rehabil. 2006 Nov;20(11):999-1016. doi: 10.1177/0269215506070700.

    PubMed 17065543

  • Miller WC, Speechley M, Deathe B. The prevalence and risk factors of falling and fear of falling among lower extremity amputees. Arch Phys Med Rehabil. 2001 Aug;82(8):1031-7. doi: 10.1053/apmr.2001.24295.

    PubMed 11494181

  • Krimmer H, Wiemer P, Kalb K. [Comparative outcome assessment of the wrist joint--mediocarpal partial arthrodesis and total arthrodesis]. Handchir Mikrochir Plast Chir. 2000 Nov;32(6):369-74. doi: 10.1055/s-2000-10915. German.

    PubMed 11189889

  • Macefield VG. Physiological characteristics of low-threshold mechanoreceptors in joints, muscle and skin in human subjects. Clin Exp Pharmacol Physiol. 2005 Jan-Feb;32(1-2):135-44. doi: 10.1111/j.1440-1681.2005.04143.x.

    PubMed 15730450

  • Lin YT, Berger RA, Berger EJ, Tomita K, Jew JY, Yang C, An KN. Nerve endings of the wrist joint: a preliminary report of the dorsal radiocarpal ligament. J Orthop Res. 2006 Jun;24(6):1225-30. doi: 10.1002/jor.20166.

    PubMed 16705705

  • Lewallen RP, Johnson EW Jr. Fractures in amputation stumps: review of treatment of 16 fractures. Mayo Clin Proc. 1981 Jan;56(1):22-6.

    PubMed 7453246

Questions about this trial

What is this clinical trial studying?

An observational study of Limb Injury, run by Mayo Clinic at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Trunk Position (time frame: Change from baseline at 0, 3, and 6 months after completing training). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03446131, which also lists 29 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2021.

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