Spinal Cord InjuryPhase 2NCT00006429
Treadmill Training for Spinal Cord Injury
A Phase 2 study testing body weight-supported treadmill training in people with Spinal Cord Injury, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 7 sites in 2 countries.
Trial summary
This is a trial to test whether treadmill training can be used to improve the "walking" of patients with partial spinal cord injury. While on the treadmill, patients will be partially supported through the use of a specially designed harness attached to an overhead lift (also called Body Weight Supported Treadmill… Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- body weight-supported treadmill training
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Mar 1999to Feb 2004
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Traumatic spinal cord injury (within 56 days)
- Incomplete lesion: - ASIA C or D, from below C4 to L3 - ASIA B at or below C7
- Unable to ambulate over ground without at least moderate assistance (FIM locomotor 3 or less)
- Able to offer at least 3/5 strength in elbow extensors
- No clinically-significant cognitive impairment
Who cannot join
- Symptomatic fall in blood pressure greater than 30 mm Hg when upright
- Halo or other cervical brace or TLSO (unless primary surgeon agrees)
- Contraindication to weight bearing on lower extremities
- Pressure sore with any skin breakdown below level of the SCI
- Any debilitating disease prior to the acute SCI that would cause exercise intolerance
- Premorbid, ongoing major depression or psychosis
- Required use of anti-spasticity medication
- Subject unlikely to complete intervention or return for follow-up
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States5 sites
Shepherd Center
Atlanta, Georgia, 30309
Ohio State University
Columbus, Ohio, 43210
Rancho Los Amigos Medical Center
Downey, California, 90242
Six Franklin Plaza
Philadelphia, Pennsylvania, 19102
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Canada2 sites
McGill University
Montreal, Quebec, H3G 1Y5
University of Ottawa
Ottawa, Ontario, K1H 8M2
About this study
Official title: Locomotor Therapy Trial for Spinal Cord Injury
This is a trial to test whether treadmill training can be used to improve the "walking" of patients with partial spinal cord injury. While on the treadmill, patients will be partially supported through the use of a specially designed harness attached to an overhead lift (also called Body Weight Supported Treadmill Training, BWSTT). Patients who enroll in this study will be randomly assigned to either the experimental group, which receives 12 weeks of this specialized treadmill training with regular physical therapy, or to the control group, which receives 12 weeks regular physical therapy. The ability of the patients to "walk" will be measured before and after treatment as well as 6 and 12 months later, using standard tests that examine mobility independence and speed of ambulation. The trial takes place across five sites in the US and Canada. Patients eligible for this trial will have had a traumatic spinal cord injury within 8 weeks of trial entry.
Read the detailed description
This is a 5-site randomized clinical trial of a task-oriented locomotor intervention for acute spinal cord injury (SCI). The intervention, body weight-supported treadmill training (BWSTT), partially supports the weight of the patient via an overhead lift attached to a harness. Therapists train the patient to walk on a treadmill by correcting gait deviations and manipulating sensory input that enhance control of the stance and swing phases of walking at increasingly higher speeds and less weight support. 100 patients with incomplete SCI (from below C4 to T10/11) and 100 patients with lesions at T12 to L3 will be randomly assigned to 12 weeks of conventional therapy programs for mobility versus the same intensity and duration of a combination of conventional therapy plus BWSTT. The primary outcome measures are the level of independence for ambulation and the maximal speed for walking 50 feet. Patients will be tested by masked examiners before and after the 12 weeks of therapy, and 6 and 12 months after entry into the study.
- Conditions
- Spinal Cord Injury
- Being tested
- body weight-supported treadmill training
- Keywords
- Spinal Cord Injury, Body Weight Supported Ambulation Training, Treadmill Training, Physical therapy, Gait, Assisted Ambulation
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
body weight-supported treadmill trainingProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2000 (estimated)
- Study startMar 1999
- Primary completionFeb 2004
- Study completionFeb 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Investigators
- Bruce H. Dobkin, MD, Principal investigator, University of California at Los Angeles (UCLA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006429
- Sponsor's protocol ID
- NICHD-0103
- Other IDs
- U01HD037439
- Status last verified
- May 2011
- First submitted
- 1 Nov 2000
- Last updated
- 26 Sep 2016
- Results posted
- No
Publications
Dobkin, B. "Recovery of Locomotor Control". The Neurologist 1996:239-249.
Dobkin, B. "An Overview of Treadmill Locomotor Training with Patrial Body Weight Support: A Neurologically Sound Approach Whose Time Has Come for Randomized Clinical Trials," Neurorehabilitation and Neuronal Repair, 1999 13(3):157-165.
Dobkin BH, Apple D, Barbeau H, Basso M, Behrman A, Deforge D, Ditunno J, Dudley G, Elashoff R, Fugate L, Harkema S, Saulino M, Scott M. Methods for a randomized trial of weight-supported treadmill training versus conventional training for walking during inpatient rehabilitation after incomplete traumatic spinal cord injury. Neurorehabil Neural Repair. 2003 Sep;17(3):153-67. doi: 10.1177/0888439003255508.
PubMed 14503436
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Locomotor Therapy Trial for Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT00006429
- Acronym / sponsor ID
- NICHD-0103
- Conditions
- Spinal Cord Injury
- Keywords
- Spinal Cord Injury, Body Weight Supported Ambulation Training, Treadmill Training, Physical therapy, Gait, Assisted Ambulation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- Mar 1999
- Primary completion
- Feb 2004 (actual)
- Study completion
- Feb 2004
- First posted
- 2 Nov 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a trial to test whether treadmill training can be used to improve the "walking" of patients with partial spinal cord injury. While on the treadmill, patients will be partially supported through the use of a specially designed harness attached to an overhead lift (also called Body Weight Supported Treadmill Training, BWSTT). Patients who enroll in this study will be randomly assigned to either the experimental group, which receives 12 weeks of this specialized treadmill training with regular physical therapy, or to the control group, which receives 12 weeks regular physical therapy. The ability of the patients to "walk" will be measured before and after treatment as well as 6 and 12 months later, using standard tests that examine mobility independence and speed of ambulation. The trial takes place across five sites in the US and Canada. Patients eligible for this trial will have had a traumatic spinal cord injury within 8 weeks of trial entry.
Detailed description
This is a 5-site randomized clinical trial of a task-oriented locomotor intervention for acute spinal cord injury (SCI). The intervention, body weight-supported treadmill training (BWSTT), partially supports the weight of the patient via an overhead lift attached to a harness. Therapists train the patient to walk on a treadmill by correcting gait deviations and manipulating sensory input that enhance control of the stance and swing phases of walking at increasingly higher speeds and less weight support. 100 patients with incomplete SCI (from below C4 to T10/11) and 100 patients with lesions at T12 to L3 will be randomly assigned to 12 weeks of conventional therapy programs for mobility versus the same intensity and duration of a combination of conventional therapy plus BWSTT. The primary outcome measures are the level of independence for ambulation and the maximal speed for walking 50 feet. Patients will be tested by masked examiners before and after the 12 weeks of therapy, and 6 and 12 months after entry into the study.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Traumatic spinal cord injury (within 56 days)
- Incomplete lesion: - ASIA C or D, from below C4 to L3 - ASIA B at or below C7
- Unable to ambulate over ground without at least moderate assistance (FIM locomotor 3 or less)
- Able to offer at least 3/5 strength in elbow extensors
- No clinically-significant cognitive impairment
Key exclusion criteria (8 listed)
- Symptomatic fall in blood pressure greater than 30 mm Hg when upright
- Halo or other cervical brace or TLSO (unless primary surgeon agrees)
- Contraindication to weight bearing on lower extremities
- Pressure sore with any skin breakdown below level of the SCI
- Any debilitating disease prior to the acute SCI that would cause exercise intolerance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| body weight-supported treadmill training | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2016.
- BackgroundDobkin, B. "Recovery of Locomotor Control". The Neurologist 1996:239-249.
- BackgroundDobkin, B. "An Overview of Treadmill Locomotor Training with Patrial Body Weight Support: A Neurologically Sound Approach Whose Time Has Come for Randomized Clinical Trials," Neurorehabilitation and Neuronal Repair, 1999 13(3):157-165.
- Background: PubMed 14503436Dobkin BH, Apple D, Barbeau H, Basso M, Behrman A, Deforge D, Ditunno J, Dudley G, Elashoff R, Fugate L, Harkema S, Saulino M, Scott M. Methods for a randomized trial of weight-supported treadmill training versus conventional training for walking during inpatient rehabilitation after incomplete traumatic spinal cord injury. Neurorehabil Neural Repair. 2003 Sep;17(3):153-67. doi: 10.1177/0888439003255508.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce H. Dobkin, MD principal investigator
University of California at Los Angeles (UCLA)
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing body weight-supported treadmill training in people with Spinal Cord Injury, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00006429, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2016.