Treadmill Training With Lower Extremity Amputees

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01419288

Enrollment

Registered

2011-08-18

Start date

2009-06-30

Completion date

2012-06-30

Last updated

2013-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Amputation of Lower Extremity

Keywords

Amputees

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.

Interventions

OTHERTreadmill Training

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to 70 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Change from Baseline in 6-minute walk test	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026