Treadmill Training With Lower Extremity Amputees

Phase 1CompletedNCT01419288

Stony Brook University8 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Traumatic Amputation of Lower Extremity

Interventions

Treadmill TrainingOTHER

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.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Stony Brook University Medical Center

Stony Brook, New York, United States

Outcomes

Primary Outcomes

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

Time frame: Baseline, after training, 1 month follow-up

Data from ClinicalTrials.gov

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