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临床试验/CTRI/2024/03/064145
CTRI/2024/03/064145尚未招募1 期

Design and Evaluation of Modified Dynamic Hallux Valgus Splint Incorporating Arch Support for Mild to Moderate Hallux Valgus Deformity on Hallux Valgus Angle, Balance and Foot Function

Rukhsana1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2024年4月1日最近更新:

试验速览

阶段
1 期
状态
尚未招募
发起方
入组人数
28
试验地点
1
主要终点
hallux valgus angle by evaluating through goniometer of the participant

研究概览

简要总结

Hallux valgus is a complex progressive deformity affecting the forefoot in which lateral deviation of the great toe is the most obvious feature. It is associated with a bunion, i.e., the prominent first metatarsal medial eminence and overlying chronically inflamed adventitious bursa. The deformity comprises medial deviation of the first metatarsal, giving rise to a widened forefoot and lateral deviation with or without pronation of the hallux. The prevalence is up to 23% in age 18–65-year-old and >35% in older than 65 years. The etiology of HV is not completely understood and appears to be multifactorial. Different conservative treatment options have been proposed for first-line treatment, including different kinds of orthoses, splints and manual therapy. Orthoses have been proposed to reduce the elevated plantar pressure under the medial ray in patients with HV and reduce pain. The previous studies suggest that a foot orthoses with medial arch support mechanism is efficient for relieving and redistributing the plantar pressure on the first metatarsophalangeal joint but studies have not incorporated both the mechanisms of arch support as well as toe alignment to evaluate its effect on hallux valgus. So, the aim of this study is to design and investigate the effect of modified dynamic hallux valgus splint incorporating arch support on Hallux valgus angle, balance (static and dynamic) and foot function. Procedure will start from analyzing the requirement and modifying dynamic hallux valgus splint by incorporating the arch support mechanism in it. Designing and fabrication of the splint will be done. Prototype of hallux valgus splint incorporating arch support mechanism will be ready for testing and clinical trial. The prototype trail would be done on patient under the supervision of the guide in a clinical setup. Rectification of the splint will be done by analyzing the practical demonstration and trial provided to the patient in the clinical setup. After several rectification and modification, prototype will be ready for the evaluation the effectiveness of dynamic HV splint incorporating arch support mechanism to be tested on various parameters including HV angle, balance (static and dynamic) and foot function. Place of the research will be Indian spinal injury center, Vasant Kunj, New Delhi. Risks and discomforts associated with the study are minimum to low. Sampling will be done using non probability convenient sampling method. Subjects diagnosed with hallux valgus will be recruited according to the inclusion criteria by convenient sampling. The data of the subjects who are willing to participate in the study will be collected after taking consent. Pre-test data of HV angle, static balance, dynamic balance and foot function will be collected using goniometer, single leg stance test, star excursion balance test and foot function respectively. Intervention of modified hallux valgus splint incorporating arch support will be provided to the patient for four weeks. Follow-up will be taken after every week. After the completion of four-week intervention period post test data of HV angle, balance (static and dynamic) and foot function will be collected. The collected data will be analyzed using SPSS (Statistical package for the social science software).

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
19.00 Year(s) 至 45.00 Year(s)(—)
性别
All

入选标准

  • Mild to moderate hallux valgus Flexible hallux valgus Hallux valgus angle ranging from 15-35â—¦ as per Manchester scale Age: 19-45 years Sufficient education to complete a questionnaire independently Commitment to wear wide toe box footwear.

排除标准

  • Severe hallux valgus Disease impacting foot condition such as diabetes, gout, leprosy Dislocations or fractures of metatarsophalangeal joints Hindfoot deformities Cognitive or psychological problems that could influence the study i.e. neurological deficits Any surgical history of foot.

结局指标

主要结局

hallux valgus angle by evaluating through goniometer of the participant

时间窗: before and after 4 week intervention with modified dynamic hallux valgus splint incorporating arch support

次要结局

  • static balance, dynamic balance, foot function(after 4 week intervention after providing modified dynamic hallux splint incorporating arch support)

研究者

发起方
Rukhsana
申办方类型
Other [self financing]
责任方
Principal Investigator
主要研究者

Rukhsana

Indian Spinal Injury Centre, Institute of Rehabilitation Sciences

研究点 (1)

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