Spinal Cord InjuriesNCT04034108
Early Surgical Intervention Combined With Weight-supported Walking Training
A study testing Surgical intervention combined with weight-supported ambulation training in people with Spinal Cord Injuries, run by Kunming Tongren Hospital at 2 sites in China.
Trial summary
To determine the efficacy of a novel combinatorial treatment involving early surgical intervention and long-term weight-bearing walking training in spinal cord injury (SCI) patients clinically diagnosed as complete or American Spinal Injury Association Impairment Scale Class A (AIS-A). Read more about this study
- Who is it for?
- Ages 4 to 76 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Surgical intervention combined with weight-supported ambulation training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 339 participants
- Where
- 2 sitesChina
- Study dates
- 1 May 2000to 1 May 2013
- Phase
- Interventional
- 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 4 to 76 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- injury levels included cervical, thoracic and lumbar spinal levels;
- neurological examination was AIS-A;
- diagnosis of SCI was confirmed by MRI.
Who cannot join
- penetrating injuries that caused complete transection of the spinal cord;
- patients with severe brain injuries or other neurological disorders;
- patients with lower motoneuron diseases;
- patients with other conditions including pregnancy, and significant medical, infectious, and psychiatric conditions.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Kunming General Hospital of Chengdu Military Command
Kunming, Yunnan
Kunming Tongren Hospital
Kunming, Yunnan
About this study
Official title: Early Surgical Intervention Combined With Weight-supported Walking Training Improves Neurological and Locomotor Recoveries in 339 Clinically Complete Human Spinal Cord Injuries
To determine the efficacy of a novel combinatorial treatment involving early surgical intervention and long-term weight-bearing walking training in spinal cord injury (SCI) patients clinically diagnosed as complete or American Spinal Injury Association Impairment Scale Class A (AIS-A).
Read the detailed description
In the present study, the investigators reported the efficacy of a novel combinatorial approach involving early surgical intervention and long-term weight-bearing walking training in SCI patients clinically defined as complete or AIS-A. The surgical intervention involves the intradural decompression (via durotomy), and, in some cases, intraspinal decompression (via myelotomy). In addition, the investigators had developed a weight-bearing walking training program named "Kunming Locomotion Training Program (KLTP)" to train the patient to walk actively for a duration of 6 hours per day, 6 days per week for a minimum of 6 months (6-6-6 KLTP). The investigators reasoned that early surgical intradural and/or intraspinal decompression would release the intraspinal pressure and, therefore, spare surrounding tissues that would otherwise degenerate during the course of secondary injury. The investigators further reasoned that long-term weight-bearing walking training would "retrain" the residual spinal pathways facilitating recovery of locomotor function, and that a combination of the two would result in even greater functional recoveries.
- Conditions
- Spinal Cord Injuries
- Being tested
- Surgical intervention combined with weight-supported ambulation training
- Keywords
- surgical intervention, decompression, walking training, functional recovery, spinal cord injury
- 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.
Surgical intervention combined with weight-supported ambulation trainingProcedure or surgery
Surgeries were performed between 12 hours to 30 days after trauma. Internal fixation was implemented once instability of the injured spinal column was confirmed by radiology and exploration during operation. At 15 days after surgery, the patients were encouraged to start weight-supported ambulation training under careful protection by the trainers, the patients were encouraged to start weight-supported ambulation training under careful protection by the trainers. The training program was named "Kunming Locomotor Training Program (KLTP)"formulated by actively walking for a duration of 6 hours per day, 6 days per week for a minimum of 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Experiment group | Experimental | All the patients were classified as AIS-A at the time of admission to the clinical center. The MRI was performed in all cases prior to and after the surgery. Surgeries were performed between 12 hours to 30 days after trauma. At 15 days after surgery, with protection of a tailored chest-waist cast made of polyurethane 8 foam for thoracic/lumbar injuries or a neck support for cervical injuries, the patients were encouraged to start weight-supported ambulation training under careful protection by the trainers. Receives: Procedure: Surgical intervention combined with weight-supported ambulation training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Kunming Locomotor Scale (KLS)
Kunming Locomotor Scale is a 10-grade Roman numeral locomotion scoring system. Grade I, the patient can not stand; grade II, the patient is able to stand with weight support and help in fixing the knee; grade III, the patient is able to stand with weight support; grade IV, the patient is able to walk with wheeled weight support and help in fixing the knee of the weight bearing leg; grade V, the patient is able to walk with wheeled weight support; grade VI, the patient is able to walk with the help of a light four-leg support; grade VII, the patient is able to walk with a pair of crutches; grade VIII, the patient is able to walk with a cane; grade IX, the patient is able to walk without support but staggeringly; and grade X, the patient is able to walk stably without support.
Measured: Before surgery, Day 15, Month 3, and Month 6
Secondary outcomes (2)
Change of American Spinal Injury Association Impairment Scale (AIS)
American Spinal Injury Association Impairment Scale (AIS), as international standards for neurological classification of spinal cord injury, is a 5 point ordinal scale to identify patient's sensory and motor levels, from AIS-A (complete SCI) to AIS-E (normal sensory and motor function).
Measured: Before surgery (baseline), Day 15, Month 3, and Month 6
Magnetic Resonance Imaging
Magnetic Resonance Imaging (MRI) are performed prior to the surgery to provided important measures determining the injury level, severity, and indication of a surgical intervention.
Measured: Before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2019
- Study start1 May 2000
- Primary completion1 May 2013
- Study completion1 May 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 339 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kunming Tongren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui Zhu, Kunming Tongren Hospital
- Investigators
- Hui Zhu, Principal investigator, Kunming Tongren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04034108
- Sponsor's protocol ID
- KunmingTH_HZ_002
- Status last verified
- Jul 2019
- First submitted
- 17 Jul 2019
- Last updated
- 26 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liu Y, Xie JX, Niu F, Xu Z, Tan P, Shen C, Gao H, Liu S, Ma Z, So KF, Wu W, Chen C, Gao S, Xu XM, Zhu H. Surgical intervention combined with weight-bearing walking training improves neurological recoveries in 320 patients with clinically complete spinal cord injury: a prospective self-controlled study. Neural Regen Res. 2021 May;16(5):820-829. doi: 10.4103/1673-5374.297080.
PubMed 33229715
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Surgical Intervention Combined With Weight-supported Walking Training Improves Neurological and Locomotor Recoveries in 339 Clinically Complete Human Spinal Cord Injuries
- ClinicalTrials.gov ID
- NCT04034108
- Acronym / sponsor ID
- KunmingTH_HZ_002
- Conditions
- Spinal Cord Injuries
- Keywords
- surgical intervention, decompression, walking training, functional recovery, spinal cord injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 339 participants (actual)
- Lead sponsor
- Kunming Tongren HospitalUniversity, hospital or other
- Study start
- 1 May 2000 (actual)
- Primary completion
- 1 May 2013 (actual)
- Study completion
- 1 May 2013 (actual)
- First posted
- 26 Jul 2019 (actual)
- 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.
To determine the efficacy of a novel combinatorial treatment involving early surgical intervention and long-term weight-bearing walking training in spinal cord injury (SCI) patients clinically diagnosed as complete or American Spinal Injury Association Impairment Scale Class A (AIS-A).
Detailed description
In the present study, the investigators reported the efficacy of a novel combinatorial approach involving early surgical intervention and long-term weight-bearing walking training in SCI patients clinically defined as complete or AIS-A. The surgical intervention involves the intradural decompression (via durotomy), and, in some cases, intraspinal decompression (via myelotomy). In addition, the investigators had developed a weight-bearing walking training program named "Kunming Locomotion Training Program (KLTP)" to train the patient to walk actively for a duration of 6 hours per day, 6 days per week for a minimum of 6 months (6-6-6 KLTP). The investigators reasoned that early surgical intradural and/or intraspinal decompression would release the intraspinal pressure and, therefore, spare surrounding tissues that would otherwise degenerate during the course of secondary injury. The investigators further reasoned that long-term weight-bearing walking training would "retrain" the residual spinal pathways facilitating recovery of locomotor function, and that a combination of the two would result in even greater functional recoveries.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experiment group | Experimental | Procedure: Surgical intervention combined with weight-supported ambulation trainingAll the patients were classified as AIS-A at the time of admission to the clinical center. The MRI was performed in all cases prior to and after the surgery. Surgeries were performed between 12 hours to 30 days after trauma. At 15 days after surgery, with protection of a tailored chest-waist cast made of polyurethane 8 foam for thoracic/lumbar injuries or a neck support for cervical injuries, the patients were encouraged to start weight-supported ambulation training under careful protection by the trainers. |
Who may qualify
- Ages
- 4 to 76 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- injury levels included cervical, thoracic and lumbar spinal levels;
- neurological examination was AIS-A;
- diagnosis of SCI was confirmed by MRI.
Key exclusion criteria (4 listed)
- penetrating injuries that caused complete transection of the spinal cord;
- patients with severe brain injuries or other neurological disorders;
- patients with lower motoneuron diseases;
- patients with other conditions including pregnancy, and significant medical, infectious, and psychiatric conditions.
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 |
|---|---|---|
| Surgical intervention combined with weight-supported ambulation trainingSurgeries were performed between 12 hours to 30 days after trauma. Internal fixation was implemented once instability of the injured spinal column was confirmed by radiology and exploration during operation. At 15 days after surgery, the patients were encouraged to start weight-supported ambulation training under careful protection by the trainers, the patients were encouraged to start weight-supported ambulation training under careful protection by the trainers. The training program was named "Kunming Locomotor Training Program (KLTP)"formulated by actively walking for a duration of 6 hours per day, 6 days per week for a minimum of 6 months. | Procedure or surgery | Experiment group |
Primary outcome
Change of Kunming Locomotor Scale (KLS)
Time frame: Before surgery, Day 15, Month 3, and Month 6
Kunming Locomotor Scale is a 10-grade Roman numeral locomotion scoring system. Grade I, the patient can not stand; grade II, the patient is able to stand with weight support and help in fixing the knee; grade III, the patient is able to stand with weight support; grade IV, the patient is able to walk with wheeled weight support and help in fixing the knee of the weight bearing leg; grade V, the patient is able to walk with wheeled weight support; grade VI, the patient is able to walk with the help of a light four-leg support; grade VII, the patient is able to walk with a pair of crutches; grade VIII, the patient is able to walk with a cane; grade IX, the patient is able to walk without support but staggeringly; and grade X, the patient is able to walk stably without support.
2 secondary outcomes
Change of American Spinal Injury Association Impairment Scale (AIS)
Time frame: Before surgery (baseline), Day 15, Month 3, and Month 6
Magnetic Resonance Imaging
Time frame: Before surgery
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 Jul 2019.
- Derived from this study: PubMed 33229715Liu Y, Xie JX, Niu F, Xu Z, Tan P, Shen C, Gao H, Liu S, Ma Z, So KF, Wu W, Chen C, Gao S, Xu XM, Zhu H. Surgical intervention combined with weight-bearing walking training improves neurological recoveries in 320 patients with clinically complete spinal cord injury: a prospective self-controlled study. Neural Regen Res. 2021 May;16(5):820-829. doi: 10.4103/1673-5374.297080.
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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.
Hui Zhu principal investigator
Kunming Tongren Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical intervention combined with weight-supported ambulation training in people with Spinal Cord Injuries, run by Kunming Tongren Hospital at 2 sites in China.
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 3 inclusion and 4 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 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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.
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.
What does the primary outcome measure?
Change of Kunming Locomotor Scale (KLS) (time frame: Before surgery, Day 15, Month 3, and Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04034108, which also lists 1 linked publication.
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 Jul 2019.