Treadmill Training With Lower Extremity Amputees - Full Text View

Purpose

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.

Condition	Intervention	Phase
Traumatic Amputation of Lower Extremity	Other: Treadmill Training	Phase 1

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

Resource links provided by NLM:

MedlinePlus related topics: Limb Loss

U.S. FDA Resources

Further study details as provided by Stony Brook University:

Primary Outcome Measures:

Change from Baseline in 6-minute walk test [ Time Frame: Baseline, after training, 1 month follow-up ] [ Designated as safety issue: No ]
Participants will be assessed 3 times: Baseline, 1 week after completing the training protocol, and then 1 month after completing the training protocol

Enrollment:	8
Study Start Date:	June 2009
Study Completion Date:	June 2012
Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: No Body weight support	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.
Experimental: Body weight support	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.

Arms

Assigned Interventions

Active Comparator: No Body weight support

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.

Experimental: Body weight support

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.

Eligibility

Ages Eligible for Study:	21 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01419288

Locations

United States, New York
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794

Sponsors and Collaborators

Stony Brook University

Investigators

Principal Investigator:

Eric Lamberg, EdD, PT

Stony Brook University

More Information

No publications provided

Responsible Party:	Eric Lamberg, Clinical Associate Professor, Stony Brook University
ClinicalTrials.gov Identifier:	NCT01419288 History of Changes
Other Study ID Numbers:	2009-0573-1
Study First Received:	August 11, 2011
Last Updated:	January 8, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by Stony Brook University:

Amputees

Additional relevant MeSH terms:

Amputation, Traumatic
Leg Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on May 23, 2013