Treadmill Training With Lower Extremity Amputees

Traumatic Amputation of Lower Extremity Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01419288
• Other study ID #: 2009-0573-1
• Status: Completed
• Phase: Phase 1
• First received: August 11, 2011
• Last updated: January 8, 2013
• Start date: June 2009
• Est. completion date: June 2012

Study information

• Verified date: January 2013
• Source: Stony Brook University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Amputation, Traumatic
• Leg Injuries
• Traumatic Amputation of Lower Extremity

Intervention

Other:
• Treadmill 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.

Locations

Country	Name	City	State
United States	Stony Brook University Medical Center	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
Stony Brook University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline, after training, 1 month follow-up	No