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临床试验/CTRI/2025/07/091656
CTRI/2025/07/091656招募中不适用

Immediate effect of Instrument Assisted Soft Tissue Mobilization (IASTM) on Hamstring and Gastrocnemius flexibility and spasticity in individuals with spastic Cerebral Palsy (CP).

Dr. Pranali Redekar1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2025年8月1日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
36
试验地点
1
主要终点
Modified Tardieu Scale (MTS),

研究概览

简要总结

Cerebral Palsy (CP) is a neurological disorder caused by non-progressive brain malformation during fetal or infant development, leading to movement impairments, muscle weakness, and spasticity. Spastic CP is the most prevalent type, affecting nearly 75% of individuals with CP. Spasticity, characterized by increased muscle stiffness and resistance to passive stretching, often results in joint deformities, contractures, and restricted mobility, significantly affecting the quality of life. Managing spasticity remains a challenge for rehabilitation teams, requiring effective interventions to improve functional independence. Instrument-Assisted Soft Tissue Mobilization (IASTM) has gained attention as a non-invasive technique to enhance flexibility and reduce spasticity. It involves using specially designed tools to break down myofascial adhesions, stimulate fibroblast activity, and promote collagen remodeling, improving muscle function. While IASTM has shown promise in musculoskeletal conditions, research on its effects in CP remains limited, particularly regarding its immediate impact on spastic muscles. This study aims to evaluate the immediate effects of IASTM on hamstring and gastrocnemius flexibility and spasticity in individuals with spastic CP. The primary objective is to assess dynamic muscle length (R2-R1) before and after IASTM treatment using the Modified Tardieu Scale (MTS) and compare pre- and post-treatment values to determine its immediate effectiveness. This experimental pre-post study will be conducted at a tertiary healthcare center, involving individuals with spastic CP aged four years and above. Participants must have a Modified Ashworth Scale (MAS) grading of 1+ to 3 for the hamstring and gastrocnemius following routine anti-spastic medications. Exclusion criteria include severe contractures, recent botulinum toxin injections, lower limb surgeries, uncontrolled epilepsy, or skin infections over the treatment area. Ethical approval from the Institutional Ethics Committee (IEC) and Departmental Review Board (DRB) will be obtained before recruitment. Parents or guardians will receive detailed information about the study, and written informed consent will be collected. Pre-treatment assessment will include MAS grading for spasticity, MTS measurements for dynamic muscle length (R2-R1), and passive range of motion (PROM) measurements for knee flexion and ankle dorsiflexion using a goniometer. The IASTM treatment will be administered using a stainless-steel Graston tool, with slow, prolonged strokes applied along the muscle fibers from origin to insertion at a 30-60 degree angle for 2-3 minutes per muscle. Immediately post-treatment, reassessment of MAS grading, MTS measurements for dynamic muscle length, and goniometric PROM values will be conducted. Ice packs wrapped in a towel will be applied to the treatment area for 5-7 minutes to minimize potential soreness. The collected data will be analyzed to determine the effectiveness of IASTM in reducing spasticity and improving muscle flexibility. Given the limitations of current treatment methods, IASTM has the potential to serve as a non-invasive, cost-efficient approach to managing spasticity in CP. If proven beneficial, it could be integrated into rehabilitation programs, improving functional outcomes and mobility in individuals with CP.

研究设计

研究类型
Interventional
分配方式
Na
盲法
Outcome Assessor Blinded

入排标准

年龄范围
4.00 Year(s) 至 40.00 Year(s)(—)
性别
All

入选标准

  • 1.Individuals diagnosed with spastic cerebral palsy with age above 4 years 2.MAS grading of hamstring & gastrocnemius between 1+ to 3 after routine antispastic medications.

排除标准

  • 1.Severe tightness and contractures of hamstrings & gastrocnemius.
  • 2.Skin infection over treatment area 3.Surgical history of lower limb within 6 months 4.Recent Botox injection within 6 months 5.Known case of epilepsy (uncontrolled) 6.Uncooperative patients.

结局指标

主要结局

Modified Tardieu Scale (MTS),

时间窗: Baseline (Pre intervention), Immediately after intervention on the same day

次要结局

  • Modified Ashworth Scale (MAS)(Baseline (Pre intervention), Immediately after intervention on the same day)
  • Goniometric PROM of knee and ankle(Baseline (Pre intervention), Immediately after intervention on the same day)

研究者

发起方
Dr. Pranali Redekar
申办方类型
Other [Self funded student study]
责任方
Principal Investigator
主要研究者

Dr Archana Gore

Physiotherapy school and Centre, Seth G. S. Medical College and KEM Hospital, Mumbai

研究点 (1)

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