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CompletedNCT01419288Updated Jan 10, 2013

Treadmill Training With Lower Extremity Amputees

A Phase 1 interventional study of Treadmill Training in Traumatic Amputation of Lower Extremity, sponsored by Stony Brook University. Completed at 1 site in United States. Open to participants aged 21 Years to 70 Years. Per ClinicalTrials.gov, last updated 2013-01-10.

Sponsored by Stony Brook University · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
8
Allocation
Randomized
Ages
21 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Traumatic Amputation of Lower Extremity

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Keywords

  • Amputees
03

In context

Amputation, Traumatic

101 studies on the registry are indexed under Amputation, Traumatic; 14 are open to participants now.

This study's enrollment of 8 is below the median of 13 across 68 interventional studies indexed under Amputation, Traumatic.

Browse Amputation, Traumatic studies →

Lead sponsor

Stony Brook University is the lead sponsor of 191 studies on the registry; 36 are open to participants now.

Of its 22 completed or terminated interventional studies of FDA-regulated products, 10 (45%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
8 participants (actual)

Study arms

  • Active comparator
    No Body weight support

    Other: Treadmill Training

  • Experimental
    Body weight support

    Other: Treadmill Training

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.

06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

1 site
  • Stony Brook University Medical Center
    Stony Brook, New York 11794, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 10, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01419288
Lead sponsor
Stony Brook University
Responsible party
Eric Lamberg (Clinical Associate Professor, Stony Brook University) — Principal investigator
First posted
Aug 18, 2011
Start date
Jun 2009
Primary completion
Jun 2012
Completion
Jun 2012
Last update
Jan 10, 2013

Study contacts

Eric Lamberg, EdD, PT
principal investigator · Stony Brook University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.

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