NCT00061295

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 1999

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1999

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

May 23, 2003

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 28, 2003

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2004

Completed
Last Updated

June 24, 2005

Status Verified

March 1, 2003

First QC Date

May 23, 2003

Last Update Submit

June 23, 2005

Conditions

Spinal Cord Injury

Keywords

LocomotionSpinal Cord InjuryBody Weight Supported Walking

Interventions

Body weight support treadmill trainingPROCEDURE

Eligibility Criteria

Age16 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Spinal cord injury at or above the T10 spine
  • 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
  • Spinal cord injury at or above the T10 spine
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Upstate Medical University

Miami, Florida, 33136, United States

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Blair M. Calancie

    University of Miami Project to Cure Paralysis

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Blair M. Calancie

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
NIH

Study Record Dates

First Submitted

May 23, 2003

First Posted

May 28, 2003

Study Start

March 1, 1999

Study Completion

February 1, 2004

Last Updated

June 24, 2005

Record last verified: 2003-03

Locations

US(1)