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临床试验/CTRI/2025/09/094232
CTRI/2025/09/094232
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Effectiveness of 4 Week Toe Out Gait Modification on Pain and Function in Patients with Knee Osteoarthritis - Randomized Controlled Trial

Dr Srishti SShetty1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2025年9月15日最近更新:

概览

阶段
不适用
状态
尚未招募
发起方
Dr Srishti SShetty
入组人数
48
试验地点
1
主要终点
1.Numeric Pain Rating Scale (NPRS)

概览

简要总结

Knee osteoarthritis is a prevalent musculoskeletal condition that significantly impacts mobility and quality of life. It is characterized by joint pain, stiffness, and functional impairment which often leads to reduced physical activity and increased disability. Conventional treatment approaches focus on pain management, physical therapy, and surgical interventions in severe cases. There is growing interest in biomechanical interventions aimed at modifying gait patterns to alleviate joint stress and slow disease progression. One such approach is toe out gait modification which involves externally rotating the foot during walking to alter load distribution within the knee joint. Previous studies have shown that toe out gait can reduce knee adduction moment and may have a protective effect against disease progression.

This study aims to evaluate the effectiveness of a 4 week toe out gait modification intervention in reducing pain and improving the quality of life in individuals with medial knee osteoarthritis.  The study population includes adults aged 45 to 70 years with unilateral medial knee osteoarthritis of Kellgren and Lawrence grade 1 and 2 who were able to walk independently. A total of 48 participants will be recruited and randomly allocated into two groups. Group A will receive toe out gait training along with conventional therapy while Group B will receive conventional therapy only. The intervention program will be conducted for 4 weeks with 4 sessions per week each lasting 40 to 45 minutes.

Outcome measures includes Numeric Pain Rating Scale NPRS, Western Ontario and McMaster Universities Osteoarthritis Index WOMAC, foot progression angle, and dynamic knee valgus. Data will be collected before and after the intervention and analyzed using appropriate statistical tests. The study is designed as a single blinded trial where participants were unaware of their allocation group.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant Blinded

入排标准

年龄范围
45.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • 1.Uniateral medial knee OA 2.Knee OA based on the radiographic evidence (Kellgren & Lawrence grade 1 and 2).
  • 3.Adults ageing 45-70 years diagnosed with medial Knee OA 4.Toe out angle less or equal to 15 degrees 5.Ability to walk independently without assistive devices.

排除标准

  • 1.Previous knee surgery or total knee replacement 2.History of lower limb fractures or neurological conditions affecting gait.
  • 3.Participation in a structured exercise program within the last 3 month 4.Severe knee OA (Kellgren & Lawrence grade 4).

结局指标

主要结局

1.Numeric Pain Rating Scale (NPRS)

时间窗: At baseline and after 4 weeks

2.Western Ontario and McMaster Universities Osteoarthritis Index

时间窗: At baseline and after 4 weeks

3.Foot Progression Angle

时间窗: At baseline and after 4 weeks

4.Dynamic knee valgus

时间窗: At baseline and after 4 weeks

次要结局

未报告次要终点

研究者

发起方
Dr Srishti SShetty
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Srishti S Shetty

Dr. G.D.Pol Foundation ,YMT College of Physiotherapy

研究点 (1)

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