Spinal Cord InjuriesNCT02663310
Treatment for Chronic Spinal Cord Injury: Surgery With Rehabilitation vs Rehabilitation
A study testing Surgery and Rehabilitation in people with Spinal Cord Injuries, run by Kunming Tongren Hospital at 1 site in China.
Trial summary
The purpose of this study is to investigate the efficacy of surgical decompression/untethering, combined with weight bearing rehabilitation, on neurological recovery following chronic spinal cord 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?
- Surgery and Rehabilitation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Jul 2015to Jun 2018
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female adult subjects, 18-60 years of age
- Have a clinical diagnosis of chronic spinal cord injury (≥ 12 months after traumatic spinal cord injury).
- Neurological examination: ASIA-A
- Injury levels: T1-T12 spinal levels
- The diagnosis of spinal cord injury is confirmed by MRI
- Subjects must be able to read, write and complete visual analogue scale
- Voluntarily signs and dates an informed Consent form, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), prior to any study-specific procedures. If a subject consents to participation but is not in a position to personally sign and date the informed consent form because of his or her physical condition, the consent must be confirmed at the time of consent orally, signed on behalf by the subject's relative, and by an impartial witness who is present throughout the whole informed consent process.
Who cannot join
- Severe head injury
- Subjects with severe osteoporosis or joint diseases
- Subjects with severe pressure sore
- Sign of kidney, cardiovascular, liver disorders
- Subjects with internal medical and/or infectious diseases (including but not limited to Hepatitis B and HIV carriers)
- Pregnant women or women at lactation stages
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- Medically or mentally unstable according to the judgment of the investigator
- History of multiple sclerosis or peripheral demyelination
- Any criteria which, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol
Trial locations and contacts
1 site in 1 country.
Hui Zhu, MD contact
China1 site, 1 recruiting
- Recruiting
Kunming Tongren Hospital
Kunming, Yunnan, 650000
Hui Zhu, MD, (86)13888092115, kmzhuhui@sina.com
About this study
Official title: Surgical Decompression/Untethering Combined With Weight Bearing Rehabilitation in Chronic Spinal Cord Injury Subjects
The purpose of this study is to investigate the efficacy of surgical decompression/untethering, combined with weight bearing rehabilitation, on neurological recovery following chronic spinal cord injury.
Read the detailed description
Safety Issues:
Safety issues need to be watched are: occurrence of known and unknown undesirable incidences, moving up injury levels, loss of previously preserved neurological functions, vital physical signs, and worsening of EKG and lab results. If unforeseen issues occur, patients will be consulted to determine whether treatments will be continued.
Adverse events:
Adverse events may occur during the trail and these events will be recorded. The severity of the events and their relationship to the experimental therapy will be determined, documented and reported to the Data Monitoring and Safety Committee who will determine how these events will be handled if they occur.
- Conditions
- Spinal Cord Injuries
- Being tested
- Surgery, Rehabilitation
- Keywords
- spinal cord injury, Kunming Locomotor Scale, surgical decompression, untethering, weight bearing rehabilitation
- 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.
SurgeryProcedure or surgery
Surgery treatment of the injured vertebra(e), internal fixation of the vertebral column, and bilateral laminectomy for epidural decompression were followed directly by neurosurgical management, including separation of the arachnoid adhesion to restore cerebrospinal fluid flow and debridement of the spinal cord necrotic tissue with concomitant intramedullary decompression.
RehabilitationProcedure or surgery
The patients need to do intensive rehabilitation everyday. （1）The limb comprehensive training is Kunming Locomotor exercise, 60 minutes twice per day.(2)The exercise therapy includes sit-ups by 30 times, twice per day; half bridge exercise by 10 times, twice per day; backward flight movement by 10 times, twice per day; sling exercise training by 30 minutes, twice per day; and postural transfer functional training by 10 minutes, twice per day. (3)The balance training include ball toss training by 10 minutes, twice per day; and balance board training by 10 minutes, twice per day. (4)The wheelchair training will be taken 20 minutes each, twice per day. (5)The isokinetic training needs to perform 20 minutes each, twice per day.
| Study group | Role | What they receive |
|---|---|---|
| Surgery with Rehabilitation | Experimental | Surgically removed cysts, and collected intracystic fluids and cerebrospinal fluid for histological and molecular analyses. Samples will be collected during the surgery and will be cryo-protected for further analyses. All subjects will enroll for intensive rehabilitation 60 days after surgery. Receives: Procedure: Surgery; Procedure: Rehabilitation |
| Rehabilitation | Active comparator | All subjects will enroll for intensive rehabilitation everyday as instruction. Receives: Procedure: Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Kunming Locomotor Scale in 1 year
Kunming Locomotor Scale is a 10-grade Roman numeral locomotion scoring system. Grade I, the patient can not stand; grade II, the patient was able to stand with weight support and help in fixing the knee; grade III, the patient was able to stand with weight support; grade IV, the patient was able to walk with wheeled weight support and help in fixing the knee of the weight bearing leg; grade V, the patient was able to walk with wheeled weight support; grade VI, the patient was able to walk with the help of a light four-leg support; grade VII, the patient was able to walk with a pair of crutches; grade VIII, the patient was able to walk with a cane; grade IX, the patient was able to walk without support but staggeringly; and grade X, the patient was able to walk stably without support.
Measured: Day 0, Day 15, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, and 1 year
Secondary outcomes (5)
Change of Walking Index for Spinal Cord Injury in 1 year
The Walking Index for Spinal Cord Injury evaluates the amount of physical assistance, braces or devices required to walk at 10 meters.
Measured: Day 0, Day 15, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, and 1 year
Change of Spinal Cord Independence Measure in 1 year
The Spinal Cord Independence Measure assesses patients' self-care, respiration and sphincter management, and mobility abilities with a total score of zero to 100.
Measured: Day 0, Day 15, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, and 1 year
Change of American Spinal Injury Association Impairment Scale in 1 year
American Spinal Injury Association Impairment Scale 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 A (complete SCI) to E (normal sensory and motor function).
Measured: Day 0, Day 15, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, and 1 year
Change of Modified Ashworth Scale in 1 year
Modified Ashworth Scale is considered the primary clinical measure of muscle spasticity in patients with neurological conditions, with Grade of 0, 1, 1+, 2, 3 and 4 (from no increase in muscle tone to affected parts rigid in flexion or extension).
Measured: Day 0, Day 15, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, and 1 year
Change of Numerical Rating Scale in 1 year
The Numerical Rating Scale is to assess pain intensity in patients who are able to self report ranging from 0 (no pain) to 10(unbearable pain).
Measured: Day 0, Day 15, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2016 (estimated)
- Study startJul 2015
- Primary completionJun 2017 (estimated)
- Study completionJun 2018 (estimated)
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kunming Tongren Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hong Kong Spinal Cord Injury Fund, China Spinal Cord Injury Network
- Responsible party
- Principal investigator, Hui Zhu, Kunming Tongren Hospital
- Investigators
- Hui Zhu, MD, Principal investigator, Kunming Tongren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02663310
- Sponsor's protocol ID
- KunmingTH_HZ_001
- Status last verified
- Jan 2016
- First submitted
- 28 Dec 2015
- Last updated
- 4 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Zhu H, Guest JD, Dunlop S, Xie JX, Gao S, Luo Z, Springer JE, Wu W, Young W, Poon WS, Liu S, Gao H, Yu T, Wang D, Zhou L, Wu S, Zhong L, Niu F, Wang X, Liu Y, So KF, Xu XM. Surgical intervention combined with weight-bearing walking training promotes recovery in patients with chronic spinal cord injury: a randomized controlled study. Neural Regen Res. 2024 Dec 1;19(12):2773-2784. doi: 10.4103/NRR.NRR-D-23-01198. Epub 2024 Jan 31.
PubMed 38595294
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Decompression/Untethering Combined With Weight Bearing Rehabilitation in Chronic Spinal Cord Injury Subjects
- ClinicalTrials.gov ID
- NCT02663310
- Acronym / sponsor ID
- KunmingTH_HZ_001
- Conditions
- Spinal Cord Injuries
- Keywords
- spinal cord injury, Kunming Locomotor Scale, surgical decompression, untethering, weight bearing rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Kunming Tongren HospitalUniversity, hospital or other
- Collaborators
- Hong Kong Spinal Cord Injury Fund, China Spinal Cord Injury Network
- Study start
- Jul 2015
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 26 Jan 2016 (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.
The purpose of this study is to investigate the efficacy of surgical decompression/untethering, combined with weight bearing rehabilitation, on neurological recovery following chronic spinal cord injury.
Detailed description
Safety Issues:
Safety issues need to be watched are: occurrence of known and unknown undesirable incidences, moving up injury levels, loss of previously preserved neurological functions, vital physical signs, and worsening of EKG and lab results. If unforeseen issues occur, patients will be consulted to determine whether treatments will be continued.
Adverse events:
Adverse events may occur during the trail and these events will be recorded. The severity of the events and their relationship to the experimental therapy will be determined, documented and reported to the Data Monitoring and Safety Committee who will determine how these events will be handled if they occur.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery with Rehabilitation | Experimental | Procedure: Surgery, Procedure: RehabilitationSurgically removed cysts, and collected intracystic fluids and cerebrospinal fluid for histological and molecular analyses. Samples will be collected during the surgery and will be cryo-protected for further analyses. All subjects will enroll for intensive rehabilitation 60 days after surgery. |
| Rehabilitation | Active comparator | Procedure: RehabilitationAll subjects will enroll for intensive rehabilitation everyday as instruction. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male or female adult subjects, 18-60 years of age
- Have a clinical diagnosis of chronic spinal cord injury (≥ 12 months after traumatic spinal cord injury).
- Neurological examination: ASIA-A
- Injury levels: T1-T12 spinal levels
- The diagnosis of spinal cord injury is confirmed by MRI
Key exclusion criteria (9 listed)
- Severe head injury
- Subjects with severe osteoporosis or joint diseases
- Subjects with severe pressure sore
- Sign of kidney, cardiovascular, liver disorders
- Subjects with internal medical and/or infectious diseases (including but not limited to Hepatitis B and HIV carriers)
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 |
|---|---|---|
| SurgerySurgery treatment of the injured vertebra(e), internal fixation of the vertebral column, and bilateral laminectomy for epidural decompression were followed directly by neurosurgical management, including separation of the arachnoid adhesion to restore cerebrospinal fluid flow and debridement of the spinal cord necrotic tissue with concomitant intramedullary decompression. | Procedure or surgery | Surgery with Rehabilitation |
| RehabilitationThe patients need to do intensive rehabilitation everyday. （1）The limb comprehensive training is Kunming Locomotor exercise, 60 minutes twice per day.(2)The exercise therapy includes sit-ups by 30 times, twice per day; half bridge exercise by 10 times, twice per day; backward flight movement by 10 times, twice per day; sling exercise training by 30 minutes, twice per day; and postural transfer functional training by 10 minutes, twice per day. (3)The balance training include ball toss training by 10 minutes, twice per day; and balance board training by 10 minutes, twice per day. (4)The wheelchair training will be taken 20 minutes each, twice per day. (5)The isokinetic training needs to perform 20 minutes each, twice per day. | Procedure or surgery | Rehabilitation, Surgery with Rehabilitation |
Primary outcome
Change of Kunming Locomotor Scale in 1 year
Time frame: Day 0, Day 15, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, and 1 year
Kunming Locomotor Scale is a 10-grade Roman numeral locomotion scoring system. Grade I, the patient can not stand; grade II, the patient was able to stand with weight support and help in fixing the knee; grade III, the patient was able to stand with weight support; grade IV, the patient was able to walk with wheeled weight support and help in fixing the knee of the weight bearing leg; grade V, the patient was able to walk with wheeled weight support; grade VI, the patient was able to walk with the help of a light four-leg support; grade VII, the patient was able to walk with a pair of crutches; grade VIII, the patient was able to walk with a cane; grade IX, the patient was able to walk without support but staggeringly; and grade X, the patient was able to walk stably without support.
5 secondary outcomes
Change of Walking Index for Spinal Cord Injury in 1 year
Time frame: Day 0, Day 15, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, and 1 year
Change of Spinal Cord Independence Measure in 1 year
Time frame: Day 0, Day 15, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, and 1 year
Change of American Spinal Injury Association Impairment Scale in 1 year
Time frame: Day 0, Day 15, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, and 1 year
Change of Modified Ashworth Scale in 1 year
Time frame: Day 0, Day 15, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, and 1 year
Change of Numerical Rating Scale in 1 year
Time frame: Day 0, Day 15, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, and 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2016.
- Derived from this study: PubMed 38595294Zhu H, Guest JD, Dunlop S, Xie JX, Gao S, Luo Z, Springer JE, Wu W, Young W, Poon WS, Liu S, Gao H, Yu T, Wang D, Zhou L, Wu S, Zhong L, Niu F, Wang X, Liu Y, So KF, Xu XM. Surgical intervention combined with weight-bearing walking training promotes recovery in patients with chronic spinal cord injury: a randomized controlled study. Neural Regen Res. 2024 Dec 1;19(12):2773-2784. doi: 10.4103/NRR.NRR-D-23-01198. Epub 2024 Jan 31.
- Hong Kong Spinal Cord Injury Fund (HKSCI Fund)Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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, MD contact
Hui Zhu, MD principal investigator
Kunming Tongren Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgery and Rehabilitation in people with Spinal Cord Injuries, run by Kunming Tongren Hospital at 1 site 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 7 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 4 Feb 2016. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hui Zhu, MD (kmzhuhui@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Kunming Locomotor Scale in 1 year (time frame: Day 0, Day 15, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, and 1 year). 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 NCT02663310, 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 4 Feb 2016.