NCT00013338

Brief Summary

This is a randomized, controlled trial to compare supported treadmill ambulation training (STAT) to conventional gait training for improving gait speed, gait endurance, gait efficiency and muscle function in SCI subjects injured more than six months prior to start of training. Each subject will receive twelve weeks of either CGT or STAT, given as 20 minutes of training within a one-hour period per day, five days per week. These subjects will be studied baseline, 4,8 and 12 weeks of training, and three months after the end of training with a battery of tests designed to evaluate the subjects' gait and muscle function.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2000

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2000

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 14, 2001

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 16, 2001

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2002

Completed
Last Updated

January 21, 2009

Status Verified

January 1, 2001

First QC Date

March 14, 2001

Last Update Submit

January 20, 2009

Conditions

Spinal Cord Injury

Keywords

Spinal cord injury, ambulation, treadmill

Interventions

Ambulation TrainingPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Spinal cord injury

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

VAMC, Houston

Houston, Texas, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

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

Study Officials

  • John Fryer, Ph.D. Asst. Director

    Program Analysis and Review Section (PARS), Department of Veterans Affairs, Rehabilitation Research and Development Service

  • Nancy Rocheleau, Program Analyst

    Program Analysis and Review Section (PARS), Department of Veterans Affairs, Rehabilitation Research and Development Service

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
FED

Study Record Dates

First Submitted

March 14, 2001

First Posted

March 16, 2001

Study Start

January 1, 2000

Study Completion

December 1, 2002

Last Updated

January 21, 2009

Record last verified: 2001-01

Locations

US(1)