Spinal Cord InjuriesPhase 2NCT00060983
Improving Gait in Patients With Spinal Cord Injuries
A Phase 2 study testing Body weight supported locomotor training and Functional electrical stimulation in people with Spinal Cord Injuries, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Body weight supported locomotor training and Functional electrical stimulation
- Type of treatment
- Surgery or procedure
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- May 1998to Apr 2002
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Spinal cord injury classified as American Spinal Injury Association (ASIA) C
- At least 1 year post injury
Who cannot join
- Spinal cord injuries of other severities (classified ASIA A, B, D, or E)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Sensory Motor Input on Gait in SCI (Spinal Cord Injured) Subjects
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.
Read the detailed description
Patients with spastic paresis due to incomplete SCI have inadequate motor control of the lower extremities that results in a number of abnormalities of movement. Among these are unregulated spinal reflexes, inadequate and delayed motor recruitment, and balance deficits. If the patient can walk, these abnormalities manifest in a gait pattern that has poorly coordinated timing between different muscle groups, decreased weight bearing capacity, and inappropriate muscle activity, such as scissoring.
Research in patients with SCIs has demonstrated that, despite the damage to the spinal cord, many of the nervous system pathways that control walking remain intact and can be activated by the proper sensory stimulation. Two technologies that may enhance the benefits of treadmill walking are body weight support (BWS) and functional electrical stimulation (FES). Preliminary studies indicate that by combining these two interventions, gait performance is improved such that more efficient and functional movement emerges. This study will evaluate the benefits of adding BWS and FES to a treadmill-training program for patients with SCIs.
During the treadmill training, patients are suspended in an apparatus to provide partial body weight support (BWS). The training effects of BWS locomotion with FES over the course of a multi-session training program will be examined. Study visits will be scheduled 3 days each week for 12 weeks. Participants will have follow-up visits at Months 3 and 12. Gait parameters modified by training will be identified and the nature of these changes will be characterized. Specifically, walking speed, kinematics, electromyography (EMG), and muscle strength will be assessed.
- Conditions
- Spinal Cord Injuries
- Being tested
- Body weight supported locomotor training, Functional electrical stimulation
- Keywords
- Locomotion, Spinal Cord Injury, ASIA C, Body weight support (BWS), Functional electrical stimulation (FES), Gait, Treadmill training, Physical Therapy
- 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 locomotor trainingProcedure or surgery
Functional electrical stimulationProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2003 (estimated)
- Study startMay 1998
- Study completionApr 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 36 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
- Edelle Carmen Field, Ph.D., P.T., Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00060983
- Sponsor's protocol ID
- 5K01HD001193-02
- Status last verified
- May 2003
- First submitted
- 16 May 2003
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sensory Motor Input on Gait in SCI (Spinal Cord Injured) Subjects
- ClinicalTrials.gov ID
- NCT00060983
- Acronym / sponsor ID
- 5K01HD001193-02
- Conditions
- Spinal Cord Injuries
- Keywords
- Locomotion, Spinal Cord Injury, ASIA C, Body weight support (BWS), Functional electrical stimulation (FES), Gait, Treadmill training, Physical Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- May 1998
- Study completion
- Apr 2002
- First posted
- 19 May 2003 (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 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.
Detailed description
Patients with spastic paresis due to incomplete SCI have inadequate motor control of the lower extremities that results in a number of abnormalities of movement. Among these are unregulated spinal reflexes, inadequate and delayed motor recruitment, and balance deficits. If the patient can walk, these abnormalities manifest in a gait pattern that has poorly coordinated timing between different muscle groups, decreased weight bearing capacity, and inappropriate muscle activity, such as scissoring.
Research in patients with SCIs has demonstrated that, despite the damage to the spinal cord, many of the nervous system pathways that control walking remain intact and can be activated by the proper sensory stimulation. Two technologies that may enhance the benefits of treadmill walking are body weight support (BWS) and functional electrical stimulation (FES). Preliminary studies indicate that by combining these two interventions, gait performance is improved such that more efficient and functional movement emerges. This study will evaluate the benefits of adding BWS and FES to a treadmill-training program for patients with SCIs.
During the treadmill training, patients are suspended in an apparatus to provide partial body weight support (BWS). The training effects of BWS locomotion with FES over the course of a multi-session training program will be examined. Study visits will be scheduled 3 days each week for 12 weeks. Participants will have follow-up visits at Months 3 and 12. Gait parameters modified by training will be identified and the nature of these changes will be characterized. Specifically, walking speed, kinematics, electromyography (EMG), and muscle strength will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Spinal cord injury classified as American Spinal Injury Association (ASIA) C
- At least 1 year post injury
Key exclusion criteria (1 listed)
- Spinal cord injuries of other severities (classified ASIA A, B, D, or E)
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 locomotor training | Procedure or surgery | – |
| Functional electrical stimulation | 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 24 Jun 2005.
- Click here for more information about the Miami Project to Cure Paralysis.Link provided by the sponsor.
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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.
Edelle Carmen Field, Ph.D., P.T. principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Body weight supported locomotor training and Functional electrical stimulation in people with Spinal Cord Injuries, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
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 2 inclusion and 1 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 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
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 24 Jun 2005.