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临床试验/CTRI/2026/02/104108
CTRI/2026/02/104108尚未招募不适用

Design and validation of calf muscle mobilization device to improve pain relief and functional mobility

School of Physiotherapy- RK University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年3月5日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
1)ankle dorsiflexion and plantarflexion range of motion (degrees) following intervention using the Calf Muscle Mobilization Device.

研究概览

简要总结

Calf muscle dysfunction, including pain, tightness, spasm, and venous congestion, is a frequent clinical problem affecting individuals across sedentary and physically active populations, often resulting in discomfort and impaired functional mobility. Conventional management approaches such as manual therapy, stretching, and compression modalities, while widely used, are commonly limited by therapist dependence, inconsistent application, and lack of standardization. To address these limitations, a self-operated device for calf muscle mobilization was designed and developed to deliver controlled, graded distal-to-proximal compression and soft tissue mobilization, simulating the physiological action of the calf muscle pump.

This study aimed to design and validate the device and to evaluate its clinical effects on pain, muscle flexibility, balance, and functional performance. The device was engineered to produce standardized, repeatable dual mode (mild and moderate comression) compression–relaxation cycles (7+8 seconds) with adjustable intensity and treatment duration, emphasizing safety, comfort, and reproducibility. The evaluation will be done before and after the 5-10 minutes of device for calf muscle mobilization, including pain intensity assessed by the Visual Analogue Scale (VAS), ankle dorsiflexion range of motion (ROM) as an indicator of calf muscle flexibility, functional mobility measured through the Timed Up and Go (TUG) test, static balance assessed by the Single Leg Stand Test, and calf muscle endurance evaluated using the Single Leg Heel Raise Test. User satisfaction and perceived usability were assessed using the QUEST 2.0 questionnaire. Device reliability was also examined.

The device functions by applying rhythmic, graded compression in a distal-to-proximal sequence, aiming to facilitate soft tissue mobilization, reduce muscle discomfort and tightness, and support venous return. The selected outcome measures (VAS, ankle dorsiflexion ROM, TUG, Single Leg Stand Test, Single Leg Heel Raise Test, and QUEST 2.0) enabled objective assessment of pain, flexibility, balance, muscular endurance, functional mobility, and user satisfaction following device use. This framework supports systematic evaluation of the device’s therapeutic utility and clinical applicability.

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 65.00 Year(s)(—)
性别
All

入选标准

  • Written informed consent to participate in the study voluntarily.
  • Person with or without calf pain.

排除标准

  • Mentally retarded patients 2)Open wounds.

结局指标

主要结局

1)ankle dorsiflexion and plantarflexion range of motion (degrees) following intervention using the Calf Muscle Mobilization Device.

时间窗: Baseline (Pre-intervention) and Immediately Post-intervention,2 weeks after baseline

次要结局

  • 1)VAS scale for pain assessment(2)single leg stance test performance (eyes open & eyes closed))

研究者

发起方
School of Physiotherapy- RK University
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dhara Kotadiya

School of Physiotherapy, RK University

研究点 (1)

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