Treatment for Chronic Spinal Cord Injury: Surgery With Rehabilitation vs Rehabilitation

NCT ID: NCT02663310

Last Updated: 2016-02-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2018-06-30

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Surgery with Rehabilitation

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.

Group Type: EXPERIMENTAL

Surgery

Intervention Type: PROCEDURE

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.

Rehabilitation

Intervention Type: PROCEDURE

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.

Rehabilitation

All subjects will enroll for intensive rehabilitation everyday as instruction.

Group Type: ACTIVE_COMPARATOR

Rehabilitation

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Rehabilitation

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hong Kong Spinal Cord Injury Fund

UNKNOWN

Sponsor Role: collaborator

China Spinal Cord Injury Network

NETWORK

Sponsor Role: collaborator

Kunming Tongren Hospital

INDUSTRY

Sponsor Role: lead

Responsible Party

Hui Zhu

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hui Zhu, MD

Role: PRINCIPAL_INVESTIGATOR

Kunming Tongren Hospital

Locations

Kunming Tongren Hospital

Kunming, Yunnan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Hui Zhu, MD

Role: CONTACT

kmzhuhui@sina.com

Facility Contacts

Hui Zhu, MD

Role: primary

kmzhuhui@sina.com

(86)13888092115

References

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.

Reference Type: DERIVED

PMID: 38595294 (View on PubMed)

Related Links

http://en.kmtrh.org/

International Spinal Cord Injury Treatment Center, Kunming Tongren Hospital

Other Identifiers

KunmingTH_HZ_001

Identifier Type: -

Identifier Source: org_study_id