Treadmill Training With Lower Extremity Amputees

NCT ID: NCT01419288

Last Updated: 2013-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2012-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

No Body weight support

Group Type: ACTIVE_COMPARATOR

Treadmill Training

Intervention Type: 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

Group Type: EXPERIMENTAL

Treadmill Training

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stony Brook University

OTHER

Sponsor Role: lead

Responsible Party

Eric Lamberg

Clinical Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eric Lamberg, EdD, PT

Role: PRINCIPAL_INVESTIGATOR

Stony Brook University

Locations

Stony Brook University Medical Center

Stony Brook, New York, United States

Countries

United States

Other Identifiers

2009-0573-1

Identifier Type: -

Identifier Source: org_study_id