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Amputation StumpsEBARNCT00126126

Evidence Based Amputee Rehabilitation (EBAR) Program

A study testing EBAR Program in people with Amputation Stumps and Diabetes Mellitus, run by US Department of Veterans Affairs at 1 site 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

The purpose of this study is to determine if an evidence based exercise intervention improves the functional mobility of diabetic amputees (single lower leg amputation) who have already completed standard rehabilitation and prosthetic training. Read more about this study

Who is it for?
Ages 40 to 80 years
Conditions the study is for
Amputation Stumps, Diabetes Mellitus
What is being tested?
EBAR Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
Jan 2005to May 2008
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • People with unilateral transtibial amputations (TTA)
  • At the lowest level of function candidates will have the ability or potential to use a prosthesis for transfers or ambulation on level surfaces at a fixed cadence. Typical of the limited and unlimited household ambulator, the majority of candidates' ability or potential for ambulation with the ability to transverse low-level environmental barriers such as curbs, stairs, or uneven surfaces (the ceiling for candidacy) will be those TTAs who have the ability to vary cadence and can ambulate within the community.
  • People with a diagnosis of diabetic mellitus and/or peripheral vascular disease leading to amputation
  • Persons comfortably fitted with a prosthesis for a period of at least 6 months
  • Candidates who have completed the "standard" course of rehabilitation and prosthetic training
  • Candidates who score in the range of 10 to 36 on the Amputee Mobility Predictor which would indicate that subjects achieved the minimum required score to be fitted with a prosthesis but they did not attain a score that is considered to be at the highest level of functioning where additional therapy would not be of significant benefit.
  • Able to tolerate a moderate intensity exercise program

Who cannot join

  • Persons receiving renal dialysis
  • Persons with severe cardiac or pulmonary disease limiting ability to exercise including angina or poorly controlled hypertension.
  • Persons with neurological disorders such as Parkinson's disease or stroke that affect ability to ambulate
  • Persons with severe lower extremity arthritis
  • Persons with wound on non-amputated side
  • Persons experiencing problems with prosthetic fit
  • Persons with poor control of diabetes

Trial locations and contacts

1 site in 1 country.

United States1 site

  • VA Medical Center, Miami

    Miami, Florida, 33125

Other trials in United States

About this study

The purpose of this study is to determine if an evidence based exercise intervention improves the functional mobility of diabetic amputees (single lower leg amputation) who have already completed standard rehabilitation and prosthetic training.

Read the detailed description

Subjects who pass all eligibility requirements will then undergo baseline testing by an examiner who will remain blinded to subject group assignment. Baseline testing will include the AAS, six-minute walk test, and both the AMPPro and AMPnoPro.

After baseline testing has been completed, subjects will be randomly assigned to either the intervention or wait list control. Randomization will occur in blocks of 20 such that for each panel of 20 subjects, 50% will be randomized to the intervention and 50% will be randomized to wait list control. Randomization will be performed using a random-number table to assign treatment group to status to each subject's unique identification number. Randomization status will be concealed by recording status on a card that is folded in half so that the group assignment is inside the fold. The cards will be placed in envelopes bearing identification numbers. When a subject has completed all baseline measures, the envelope with that subject's ID number will be opened and the subject will be assigned to a group.

Subjects assigned to the intervention group will undergo clinical strength testing. An individualized program will be developed for each subject based on his or her AMP test results and clinical strength testing. Subjects will then attend rehabilitation sessions 3 times per week for 8 weeks. Each session will last approximately 45 minutes including any required rest periods. Subjects will perform endurance, balance and strengthening exercises at each session. Every 6th session, subjects in the intervention group will perform a six-minute walk test, AMPPro and complete the AAS questionnaire. The results of each AMPPro test will be reviewed and the therapeutic exercise program revised according.

After follow-up testing, subjects assigned to the wait list condition will be eligible to attend the 8-week rehabilitation program. Wait list subjects in the exercise phase will also receive the same exercise intervention described above. They will also perform a six-minute walk test, AMPPro and complete the AAS questionnaire every 6th session.

Being tested
EBAR Program
Keywords
Artificial Limbs, Evidence based medicine, Exercise, Outcomes research, Physical therapy
Medical subject headings
Diabetes Mellitus, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EBAR ProgramOther

    Evidence Based Amputee Rehabilitation Program

Study groups in NCT00126126
Study groupRoleWhat they receive
EBAR ProgramExperimentalEvidence Based Amputee Rehabilitation Program (rehabilitation program based on performance of the Amputee Mobility Predictor
Receives: Other: EBAR Program
Wait List ControlNo interventionWait List Control Group

What is being measured

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

  1. Amputee Mobility Predictor

    The Amputee Mobility Predictor is a reliable and valid performance-based outcome measure of prosthetic mobility. The AMP is scored from 0-47, higher scores indicating greater prosthetic mobility. The AMP can help clinicians differentiate between different functional K-levels based on as defined by the Medicare Functional Classification Level (MFCL) system. Lower limb amputees functioning at the K2 level score between 27-36 on the AMP and are classified as limited community ambulators. Those at the K3 level score between 37-42 and are typical community ambulators who have the ability to traverse environmental barriers and performing activities that are beyond simple locomotion. Individuals at the K4 level score between 43-47 which is typical of prosthetic demands of an active adult or regular athlete. The minimal detectable change for the AMP is 3.4 points.

    Measured: 8 weeks for intervention and for wait-list control

Secondary outcomes (1)

  1. Six-minute Walk Test

    The six-minute walk test (6MWT) is a measure of overall functional mobility, and cardiopulmonary and musculoskeletal endurance. It assesses the distance ambulated in 6 minutes. The 6MWT has excellent reliability for lower limb amputees and can differentiate between amputee Medicare Functional Classification Levels (MFCL).Lower limb amputees functioning at the K2 level ambulate a mean distance of 200 meters. Those at the K3 level ambulate a mean distance of 300 meters. Those at the K4 level ambulate a mean distance of 400 meters. Service Members with traumatic lower limb loss ambulate a distance of 600 meters. The minimal detectable change for the 6MWT is 45 meters.

    Measured: 8 weeks for intervention and wait list control group

Timeline

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

  1. First posted2 Aug 2005 (estimated)
  2. Study startJan 2005
  3. Primary completionMay 2008
  4. Study completionMay 2008

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00126126
Sponsor's protocol ID
A3381-R
Other IDs
3019.01
Acronym
EBAR
Status last verified
Sep 2015
First submitted
1 Aug 2005
Last updated
20 Oct 2015
Data monitoring committee
Yes

Publications

  • Gailey RS, Roach KE, Applegate EB, Cho B, Cunniffe B, Licht S, Maguire M, Nash MS. The amputee mobility predictor: an instrument to assess determinants of the lower-limb amputee's ability to ambulate. Arch Phys Med Rehabil. 2002 May;83(5):613-27. doi: 10.1053/apmr.2002.32309.

    PubMed 11994800

  • Gailey RS, Scoville C, Gaunaurd IA, Raya MA, Linberg AA, Stoneman PD, Campbell SM, Roach KE. Construct validity of Comprehensive High-Level Activity Mobility Predictor (CHAMP) for male servicemembers with traumatic lower-limb loss. J Rehabil Res Dev. 2013;50(7):919-30. doi: 10.1682/JRRD.2012.05.0100.

    PubMed 24301429

  • Resnik L, Borgia M. Reliability of outcome measures for people with lower-limb amputations: distinguishing true change from statistical error. Phys Ther. 2011 Apr;91(4):555-65. doi: 10.2522/ptj.20100287. Epub 2011 Feb 10.

    PubMed 21310896

  • Gailey R, Gaunaurd I, Raya M, Kirk-Sanchez N, Prieto-Sanchez LM, Roach K. Effectiveness of an Evidence-Based Amputee Rehabilitation Program: A Pilot Randomized Controlled Trial. Phys Ther. 2020 May 18;100(5):773-787. doi: 10.1093/ptj/pzaa008.

    PubMed 31951260

Questions about this trial

What is this clinical trial studying?

A study testing EBAR Program in people with Amputation Stumps and Diabetes Mellitus, run by US Department of Veterans Affairs at 1 site 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 7 inclusion and 7 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 20 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Yes. Results are posted in the registry (first posted 20 Oct 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Amputee Mobility Predictor (time frame: 8 weeks for intervention and for wait-list control). 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 NCT00126126, which also lists 4 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 20 Oct 2015.

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