跳至主要内容
临床试验/CTRI/2025/10/096120
CTRI/2025/10/096120尚未招募Phase 3 4

Clinical, gait and balance parameters after diagnostic obturator nerve block in patients with spasticity - a pre-post interventional study

未提供1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2025年10月29日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
入组人数
15
试验地点
1
主要终点
a) Modified Ashworth Scale (MAS)

研究概览

简要总结

This study expects to find out the functional improvement in hip adductor spasticity and the change in gait and balance parameters after obturator nerve block. Patients above 18 years of age will be enrolled for the study as per inclusion and exclusion criteria. All the patients will receive anti spasticity medications at stable doses throughout the study duration. Modified Ashworth Scale (MAS), Spasm Frequency Scale, R1 of Modified Tardieu Scale (knee flexed and extended) , Gait parameters and Balance parameters will be assessed immediately before the procedure. Clinical data for primary evaluation will be obtained by examination for Modified Ashworth Scale (MAS) of adductor group of muscles, Spasm Frequency Scale and R1 of Modified Tardieu Scale (both in knee flexed and extended condition). Spatiotemporal gait parameters will be collected by using the inertial motion sensor G-WALK (G-SENSOR II) of BTS gait analysis system which uses G-STUDIO software. Balance data will be collected by using the platform BALANCE SD which uses Balance System SD Software Update v4.0.18. USG guided Obturator nerve block will be done on the affected side using 1% lidocaine. 30 minutes after the procedure, the outcome variables will be assessed again.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Patients aged greater than or equal to 18 years
  • Patients affected by hip adductor spasticity (unilateral or bilateral) because of underlying generalised or focal cerebral and spinal pathologies like cerebrovascular accident, spinal cord injury, traumatic brain injury, cerebral palsy or multiple sclerosis.
  • Hip adductor spasticity severity 1, 1 plus, 2 or 3 on the Modified Ashworth Scale (MAS)
  • Use of any anti-spasticity medications at stable doses for at least 1 month prior to enrolment, and the participant must agree to maintain same dose throughout the study.

排除标准

  • Patients who do not wish to be included in the study
  • Patients who have an allergy to lidocaine
  • Hip adductor spasticity severity 4 on the Modified Ashworth Scale (MAS)
  • Established severe contracture of the hip adductors.
  • Received recent treatment with botulinum toxin (within 6 months), phenol injection (within 24 months).
  • Unstable medical conditions such as peripheral vascular disease, hepatic disease, renal disease, coronary artery disease, malignant hyperthermia and an estimated survival of less than 6 months.
  • Patients with a history of dystonic posture or deep vein thrombosis in the lower limbs
  • Pregnant women.

结局指标

主要结局

a) Modified Ashworth Scale (MAS)

时间窗: Baseline, 30 minutes after procedure

b) Spasm Frequency Scale

时间窗: Baseline, 30 minutes after procedure

c) R1 of Modified Tardieu Scale (both in knee flexed and extended condition).

时间窗: Baseline, 30 minutes after procedure

次要结局

  • a) Gait parameters:(1. Step length, Swing time (SwT), Stance time (StT), Single-leg support time (SLST),)
  • b) Balance parameters:(1. Postural stability test)

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Jaydeep Nandi

AIIMS Raipur

研究点 (1)

Loading locations...

相似试验