Treadmill Training With Lower Extremity Amputees

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eric Lamberg, Stony Brook University
ClinicalTrials.gov Identifier:
NCT01419288
First received: August 11, 2011
Last updated: January 8, 2013
Last verified: January 2013
  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:


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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 21, 2014