NCT00126126

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 1, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 2, 2005

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
7.5 years until next milestone

Results Posted

Study results publicly available

October 20, 2015

Completed
Last Updated

October 20, 2015

Status Verified

September 1, 2015

Enrollment Period

3.3 years

First QC Date

August 1, 2005

Results QC Date

November 24, 2014

Last Update Submit

September 21, 2015

Conditions

Amputation StumpsDiabetes Mellitus

Keywords

Artificial LimbsEvidence based medicineExerciseOutcomes researchPhysical therapy

Outcome Measures

Primary Outcomes (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.

    8 weeks for intervention and for wait-list control

Secondary Outcomes (1)

  • Six-minute Walk Test

    8 weeks for intervention and wait list control group

Study Arms (2)

EBAR Program

EXPERIMENTAL

Evidence Based Amputee Rehabilitation Program (rehabilitation program based on performance of the Amputee Mobility Predictor

Other: EBAR Program

Wait List Control

NO INTERVENTION

Wait List Control Group

Interventions

EBAR ProgramOTHER

Evidence Based Amputee Rehabilitation Program

EBAR Program

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Medical Center, Miami

Miami, Florida, 33125, United States

Location

Related Publications (4)

  • 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.

    PMID: 11994800RESULT

  • 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.

    PMID: 24301429RESULT

  • 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.

    PMID: 21310896RESULT

  • 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.

    PMID: 31951260DERIVED

MeSH Terms

Conditions

Diabetes MellitusMotor Activity

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Limitations and Caveats

Recruitment was challenging. We screened over 350 veterans and non-veterans with lower limb loss and we were only able to enroll 20.

Results Point of Contact

Title
Robert Gailey, PhD, PT
Organization
Miami VAHS & University of Miami, Department of PT
rgailey@miami.edu
305-284-4535

Study Officials

  • Robert Gailey, PhD, PT

    Miami Veterans Affairs Healthcare System

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2005

First Posted

August 2, 2005

Study Start

January 1, 2005

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

October 20, 2015

Results First Posted

October 20, 2015

Record last verified: 2015-09

Locations

US(1)