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临床试验/CTRI/2024/09/074051
CTRI/2024/09/074051尚未招募3 期

Design and Development of the Footpro Rehabilitator A Comprehensive Study on Feasibility and Effectiveness in Foot Rehabilitation

Solanki Kinjal Govindbhai1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年12月2日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Ankle Joint Active Rang of Motion, VAS Scale, QUEST 2.0 Scale

研究概览

简要总结

Title: DESIGN AND DEVLOPMENT OF THE FOOTPRO REHABILITATOR: A COMPREHENSIVE STUDY ONFEASIBILITY ANDEFFECTIVENESS IN FOOT REGABILITATION

Investigator: Kinjal Solanki; PT, Dr. Amit Sharma; MPT, PhD Scholar, School of Physiotherapy, RK University.

Background: Heel pain, affecting about 10% of the general population and frequently seen in runners, often involves conditions such as Planter Fasciitis, foot Tendinopathy, Calcaneal Apophysitis, Heel Spur. Risk factors such as poor muscle flexibility, heavy lifting, obesity, and excessive foot pronation contribute to its development. It poses hindrance in day-to-day activities and is becoming more common due to decrease in physical activities in modern day life.

Conservative treatments, such as stretching and strengthening exercise, release therapy, ice therapy, and activity modifications are typically effective and preferred over surgical options due to their lower risk and greater efficacy. This clinical trial aim to assess the feasibility and effectiveness of Footpro Rehabilitator, an integrated device designed to treat heel pain by combining multiple therapies into a single, cost-effective solution.

Method: Following ethical approval, 30 subjects will be selected as per inclusion and exclusion criteria and will receive exercise training with Footpro Rehabilitator Device. Outcome measures will be assessed before treatment (Baseline) with VAS Scale, ankle joint active range of motion (ROM) and functional scale: foot functional index (FFI). post-treatment assessment will be taken with the same outcome measures after 2 weeks.

The study is divided into three phases:

Phase 1: Designing Footpro Rehabilitator as an integrated device for treating heel pain.

Phase 2: Developing Footpro Rehabilitator as an integrated device for treating heel pain.

Phase 3: Determine feasibility and effectiveness of Footpro Rehabilitator in treating heel pain.

研究设计

研究类型
Interventional
分配方式
Other
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
All

入选标准

  • (1) Individual with heel pain.

排除标准

  • (1) A patients with recent foot infection, or open wound or fracture (2) Cognitive impairments (3) Not willing to sign informed consent.

结局指标

主要结局

Ankle Joint Active Rang of Motion, VAS Scale, QUEST 2.0 Scale

时间窗: Pre Outcome at Baseline (first day of training) | Post Outcome after 2 week (last day of training)

次要结局

  • Functional Scale: FFI(Foot Functional Index)(Pre Outcome at Baseline (first day of training))

研究者

发起方
Solanki Kinjal Govindbhai
申办方类型
Other [[self]]
责任方
Principal Investigator
主要研究者

Solanki kinjal Govindbhai

School of Physiotherapy, RK University

研究点 (1)

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