Treadmill Training With Body Weight Support in Patients With Spinal Cord Injury

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2003 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00061295
First received: May 23, 2003
Last updated: June 23, 2005
Last verified: March 2003
  Purpose

Body weight support (BWS) treadmill training uses an overhead harness to give partial support to patients walking on a treadmill. This study will determine whether BWS training is more effective than conventional rehabilitation therapy in improving walking ability in patients with spinal cord injuries (SCI).


Condition Intervention Phase
Spinal Cord Injury
Procedure: Body weight support treadmill training
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Body Weight Supported Ambulation Training After Spinal Cord Injury

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Study Start Date: March 1999
Estimated Study Completion Date: February 2004
Detailed Description:

Gait rehabilitation is a specific component of physical rehabilitation of persons with sub-acute or chronic spinal cord injury (SCI). One novel method of gait rehabilitation involves the use of an overhead support point and a harness. The BWS strategy has been combined with treadmill-based gait training in recent studies with dramatic results. It is believed that this form of training may enhance output of a ‘central pattern generator' of stepping movement from circuitry intrinsic to the patient's spinal cord. However, only limited attention has been paid to the role that training-induced physical conditioning might play in mediating functional improvements.

This study will evaluate whether BWS gait training is more effective than conventional rehabilitation therapy in improving functional gait in patients with neurologically incomplete spinal cord injury. The study will also compare treadmill-based training to overground-based training. Treadmill-based training has the inherent advantage of providing highly rhythmic input to the subject's legs; overground-based training has the inherent advantage of allowing use of assistive devices and thereby replicating a more ‘natural' training condition.

Patients with chronic SCI (greater than 1 year post-injury) and patients with sub-acute SCI (2 to 8 months post-injury) will be evaluated. Patients with chronic SCI will be randomly assigned to one of 3 groups: body weight support and treadmill-based training, body weight support and overground training, and conventional rehabilitation therapy. Patients with sub-acute injury will be randomized to receive either BWS treadmill training or conventional rehabilitation. Training sessions are typically 1 hour long, with 3 sessions per week for 13 weeks.

All patients will be evaluated with a battery of functional, metabolic, and neurophysiologic measures prior to the onset of training and during the week after training has been completed. The primary outcome measure will be average maximum overground walking velocity without body weight support but with the use of passive assistive devices. Secondary measures will concentrate on function (balance, mobility), fitness (work capacity, strength, gait efficiency), and spinal cord neurophysiology (motor conduction, reflex excitability).

  Eligibility

Ages Eligible for Study:   16 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria for Patients with Chronic Injury:

  • Spinal cord injury at or above the T10 spine
  • 1 year post injury
  • Some volitional movement in one or both limbs (i.e., motor incomplete)
  • Ability to stand with limited bracing
  • Ability to rise from sit to stand with no more that moderate assistance

Inclusion Criteria for Patients with Subacute Injury:

  • Spinal cord injury at or above the T10 spine
  • 2 to 8 months post injury
  • Volitional movement in at least one lower limb muscle (i.e., motor incomplete), although may not be capable of unsupported standing or moving from sit-to-stand without maximal assistance

Exclusion Criteria:

  • Fractures at or below T11
  • Neoplastic, degenerative, or vascular disorders of the spine or spinal cord
  • Significant orthopaedic conditions that would interfere with regular exercise or rehabilitation therapy
  • Decubitus ulcer
  • Advanced urinary tract infection
  • Medical conditions that increase the probability of having a seizure in response to single pulse transcranial magnetic stimulation
  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: NCT00061295

Contacts
Contact: Blair M. Calancie 305-585-8347 bcalancie@miamiproj.med.miami.edu

Locations
United States, Florida
Upstate Medical University Recruiting
Miami, Florida, United States, 33136
Sponsors and Collaborators
Investigators
Principal Investigator: Blair M. Calancie University of Miami Project to Cure Paralysis
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00061295     History of Changes
Other Study ID Numbers: 1U01HD37460-01
Study First Received: May 23, 2003
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Locomotion
Spinal Cord Injury
Body Weight Supported Walking

Additional relevant MeSH terms:
Body Weight
Spinal Cord Injuries
Central Nervous System Diseases
Nervous System Diseases
Signs and Symptoms
Spinal Cord Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on October 22, 2014