NCT00060983

Brief Summary

This study is part of a larger clinical trial that examines the potential of a 12-week treadmill-training program to improve walking in patients with spinal cord injuries (SCIs). Patients in the trial are at least 1 year past their injury. This substudy tests a combination of two strategies to enhance the treadmill training program: electrically stimulating a muscle withdrawal reflex and providing body weight support by partially suspending patients as they walk on the treadmill.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 1998

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

May 1, 1998

Completed
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2002

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 16, 2003

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 19, 2003

Completed
Last Updated

June 24, 2005

Status Verified

May 1, 2003

First QC Date

May 16, 2003

Last Update Submit

June 23, 2005

Conditions

Spinal Cord Injuries

Keywords

LocomotionSpinal Cord Injury, ASIA CBody weight support (BWS)Functional electrical stimulation (FES)GaitTreadmill trainingPhysical Therapy

Interventions

Body weight supported locomotor trainingPROCEDURE
Functional electrical stimulationPROCEDURE

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Spinal cord injury classified as American Spinal Injury Association (ASIA) C
  • At least 1 year post injury

You may not qualify if:

  • Spinal cord injuries of other severities (classified ASIA A, B, D, or E)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Miami Project, Bantle Center

Miami, Florida, 33136, United States

Location

Related Links

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

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

Study Officials

  • Edelle Carmen Field, Ph.D., P.T.

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

May 16, 2003

First Posted

May 19, 2003

Study Start

May 1, 1998

Study Completion

April 1, 2002

Last Updated

June 24, 2005

Record last verified: 2003-05

Locations

US(1)