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Treadmill Training With Lower Extremity Amputees

Primary Purpose

Traumatic Amputation of Lower Extremity

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Treadmill Training
Sponsored by
Stony Brook University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Amputation of Lower Extremity focused on measuring Amputees

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Leg amputation that is either below the knee, through the knee, or above the knee
  • Ability to walk with prosthetic
  • Comfortably fitted with a prosthesis for at least 6 months
  • Not currently receiving physical therapy for gait training
  • Able to tolerate a moderate intensity exercise program

Exclusion Criteria:

  • People with severe cardiac or pulmonary disease that limits ability to exercise.
  • People with too much discomfort and/or pain that restricts their ability to walk.
  • People with active wounds on their residual limb or contralateral foot.
  • People who weigh more than 360lbs or are taller than 6'11" as the unweighing system can not support any greater load or height.

Sites / Locations

  • Stony Brook University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

No Body weight support

Body weight support

Arm Description

Outcomes

Primary Outcome Measures

Change from Baseline in 6-minute walk test
Participants will be assessed 3 times: Baseline, 1 week after completing the training protocol, and then 1 month after completing the training protocol

Secondary Outcome Measures

Full Information

First Posted
August 11, 2011
Last Updated
January 8, 2013
Sponsor
Stony Brook University
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1. Study Identification

Unique Protocol Identification Number
NCT01419288
Brief Title
Treadmill Training With Lower Extremity Amputees
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stony Brook University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Many people with a leg amputation have difficulty walking even after they have finished their rehabilitation. The purpose of this study is to see if a large amount of walking practice on a treadmill can improve functional abilities.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Amputation of Lower Extremity
Keywords
Amputees

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No Body weight support
Arm Type
Active Comparator
Arm Title
Body weight support
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Treadmill Training
Intervention Description
The program requires volunteer participants to attend 15 sessions over 10 to 12 weeks with a total time commitment of 13.5 hours. There is an initial testing session that includes an assessment of the participant's legs, balance, and walking abilities. The entire program includes 12 treadmill training visits that take place three times per week for four weeks, a post-training testing session one week after completion of the training, and a follow-up testing session four weeks after completion of the training.
Primary Outcome Measure Information:
Title
Change from Baseline in 6-minute walk test
Description
Participants will be assessed 3 times: Baseline, 1 week after completing the training protocol, and then 1 month after completing the training protocol
Time Frame
Baseline, after training, 1 month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Leg amputation that is either below the knee, through the knee, or above the knee Ability to walk with prosthetic Comfortably fitted with a prosthesis for at least 6 months Not currently receiving physical therapy for gait training Able to tolerate a moderate intensity exercise program Exclusion Criteria: People with severe cardiac or pulmonary disease that limits ability to exercise. People with too much discomfort and/or pain that restricts their ability to walk. People with active wounds on their residual limb or contralateral foot. People who weigh more than 360lbs or are taller than 6'11" as the unweighing system can not support any greater load or height.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Lamberg, EdD, PT
Organizational Affiliation
Stony Brook University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stony Brook University Medical Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States

12. IPD Sharing Statement

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Treadmill Training With Lower Extremity Amputees

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