Recruiting
Phase 1

Treadmill Training

Sponsor:

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Code:

NCT00061295

Conditions

Spinal Cord Injury

Eligibility Criteria

Sex: All

Age: 16 - 70

Healthy Volunteers: Not accepted

Interventions

Body weight support treadmill training

Study Details

Brief summary:

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).

Conditions

Spinal Cord Injury

Study ID

NCT00061295

Start date

Mar, 1999

Status verified date

Mar, 2003

Completion date

Feb, 2004

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16 - 70

Healthy Volunteers: Not accepted

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

Study Design

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Body weight support treadmill training

Central Contacts and Locations

Central contacts

Blair M. Calancie

305-585-8347bcalancie@miamiproj.med.miami.edu

Locations

Upstate Medical University

Recruiting

Miami, Florida, United States, 33136

More Information

Sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Last update posted

Jun 24, 2005

Last verified

Mar, 2003

Keywords

  • Locomotion
  • Spinal Cord Injury
  • Body Weight Supported Walking

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) on 2005-06-24.