Evidence Based Amputee Rehabilitation (EBAR) Program (EBAR)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00126126
First received: August 1, 2005
Last updated: September 21, 2015
Last verified: September 2015
Results First Received: November 24, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Conditions: Amputation Stumps
Diabetes Mellitus
Intervention: Other: EBAR Program

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Three hundred twenty six Individuals with unilateral lower limb loss were screened. Twenty agreed to participate in the study and completed the consent process.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Twenty individuals who met inclusion criteria completed the consent process. Eighteen were randomized to either intervention (n = 9) or wait list control (n = 9).

Reporting Groups
  Description
Intervention

Evidence Based Amputee Rehabilitation Program

Exercise: Evidence Based Amputee Rehabilitation Program

Wait-List Control Group These individuals waited 8 weeks in order to begin the intervention.

Participant Flow:   Overall Study
    Intervention     Wait-List Control Group  
STARTED     9     9  
COMPLETED     9     7  
NOT COMPLETED     0     2  
Lost to Follow-up                 0                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Intervention Those subjects who were randomized to receive the Evidence Based Amputee Rehabilitation (EBAR) Program
Wait List Control Group Those subjects who were randomized to the wait-list control group.
Total Total of all reporting groups

Baseline Measures
    Intervention     Wait List Control Group     Total  
Number of Participants  
[units: participants]
  9     7     16  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     6     6     12  
>=65 years     3     1     4  
Age  
[units: years]
Mean (Standard Deviation)
  63.4  (11.4)     63.0  (7.1)     63.3  (9.5)  
Gender  
[units: participants]
     
Female     3     0     3  
Male     6     7     13  
Region of Enrollment  
[units: participants]
     
United States     9     7     16  



  Outcome Measures
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1.  Primary:   Amputee Mobility Predictor   [ Time Frame: 8 weeks for intervention and for wait-list control ]

2.  Secondary:   Six-minute Walk Test   [ Time Frame: 8 weeks for intervention and wait list control group ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Recruitment was challenging. We screened over 350 veterans and non-veterans with lower limb loss and we were only able to enroll 20.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Robert Gailey, PhD, PT
Organization: Miami VAHS & University of Miami, Department of PT
phone: 305-284-4535
e-mail: rgailey@miami.edu


Publications of Results:

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00126126     History of Changes
Other Study ID Numbers: A3381-R
3019.01 ( Registry Identifier: Miami VA IRB )
Study First Received: August 1, 2005
Results First Received: November 24, 2014
Last Updated: September 21, 2015
Health Authority: United States: Federal Government