Selective Dorsal Rhizotomy as a Cost Effective and Safe Procedure as a Alternative to Intrathecal Baclofen Pump in Patients With Post Traumatic Spasticity
Selective Dorsal Rhizotomy as a Cost Effective and Safe Procedure as an Alternative to Intrathecal Baclofen Pump in Patients With Post Traumatic Spasticity: Multi-center Cohort Study
The investigators will investigate the selective dorsal rhizotomy in post traumatic brain and spinal cord injury induced spasticity to evaluate the efficacy of this procedure in reducing the tone of the spastic muscle groups.
Selective dorsal rhizotomy is well established effective procedure in participants with cerebral palsy associated spasticity.
As low and middle income countries, intrathecal baclofen pump is expensive for patients.
연구 개요
상태
상세 설명
Spasticity is a condition that represents a form of disability and it's associated in various conditions. Intrathecal baclofen pump is tried and has a good outcome in treatment spasticity. However, it has some aide effects and complications and also expensive.
Selective dorsal rhizotomy is a surgical procedure that represents an optional treatment for spasticity and established with cerebral palsy and hereditary spasticity.
Selective dorsal rhizotomy in participants with Post traumatic induced spasticity isn't established yet and not compared with the results of intrathecal baclofen.
SDR is a procedure applied under general anesthesia and with neuromonitoring.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Afnan Morad
- 전화번호: 01113890330
- 이메일: afnanmrad45@gmail.com
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Patients who are four year-old and above of both sexes.
- Patient with post traumatic head and / or spinal injury-induced spasticity.
- Ambulant and non-ambulant patient.
Exclusion Criteria:
- Patient below age of four year.
- Other conditions induced- spasticity e.g. Strokes, CP, MS, Hereditary spastic paresis, ALS, tumors, infections and degenerative diseases.
- Patient underwent previous intrathecal baclofen pump administration.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Selective dorsal rhizotomy parm
This will be the enrolled group of patients that will match the eligibility criteria and give the consent to undergo the surgery
|
In prone position and Under general anaesthesia, and according to neuromonitoring, a microscopic cut of the rootlet ( of the dorsal root of spinal nerve) that supply the group that is most spastic
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in spasticity severity assessed by the Modified Ashworth Scale (MAS) and electromyography (EMG) amplitude
기간: From one week to six months post operative.
|
The primary outcome will be the reduction in spasticity, quantified by the change in MAS scores and EMG muscle activity measurements from baseline to post-intervention.
The MAS score, ranged from 0 to 4 as 0 represents no increase in muscle tone and 4 indicates rigid limb flexion/extension, will be reported as the mean change in points, and EMG data will be summarized using the mean and standard deviation of muscle activity amplitude during standardized stretch protocols.
The data will be analyzed to determine the statistical significance of improvements following the selective dorsal rhizotomy procedure
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From one week to six months post operative.
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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Lindsay C, Simpson J, Ispoglou S, Sturman SG, Pandyan AD. The early use of botulinum toxin in post-stroke spasticity: study protocol for a randomised controlled trial. Trials. 2014 Jan 8;15:12. doi: 10.1186/1745-6215-15-12.
- He J, Luo A, Yu J, Qian C, Liu D, Hou M, Ma Y. Quantitative assessment of spasticity: a narrative review of novel approaches and technologies. Front Neurol. 2023 Jul 5;14:1121323. doi: 10.3389/fneur.2023.1121323. eCollection 2023.
- Shourijeh MS, Stampas A, Chang SH, Korupolu R, Francisco GE. Advancements in Understanding Spasticity: A Neuromusculoskeletal Modeling Perspective. J Clin Med. 2025 Nov 15;14(22):8092. doi: 10.3390/jcm14228092.
- Ertzgaard P, Campo C, Calabrese A. Efficacy and safety of oral baclofen in the management of spasticity: A rationale for intrathecal baclofen. J Rehabil Med. 2017 Mar 6;49(3):193-203. doi: 10.2340/16501977-2211.
- Enslin JMN, Langerak NG, Fieggen AG. The Evolution of Selective Dorsal Rhizotomy for the Management of Spasticity. Neurotherapeutics. 2019 Jan;16(1):3-8. doi: 10.1007/s13311-018-00690-4.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- SDR
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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