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Completed

NCT Number: NCT01419288

Treadmill Training With Lower Extremity Amputees

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.

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Key information

Conditions

Traumatic Amputation of Lower Extremity

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Stony Brook University Medical Center

Stony Brook, New York, 11794, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Treadmill training

Other

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 outcomes

  1. Change from Baseline in 6-minute walk test

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

    Participants will be assessed 3 times: Baseline, 1 week after completing the training protocol, and then 1 month after completing the training protocol

Sponsors and collaborators

Lead sponsor

Stony Brook University

Other

Registry information

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Aug 18, 2011
Registry last updated
Jan 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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