Treadmill Training With Lower Extremity Amputees

NCT01419288 | Completed Phase 1

• 1 other identifier: 2009-0573-1
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Amputation of Lower Extremity

Keywords

Amputees

Outcome Measures

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

  Baseline, after training, 1 month follow-up

Study Arms (2)

No Body weight support

ACTIVE COMPARATOR

Other: Treadmill Training

Body weight support

EXPERIMENTAL

Other: Treadmill Training

Interventions

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.

Body weight support; No Body weight support

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stony Brook University: lead

Study Sites (1)

Stony Brook University Medical Center

Stony Brook, New York, 11794, United States

Location

Study Officials

• Eric Lamberg, EdD, PT

  Stony Brook University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: August 11, 2011
• First Posted: August 18, 2011
• Study Start: June 1, 2009
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: January 10, 2013

Record last verified: 2013-01

Locations

US (1)