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临床试验/CTRI/2026/02/102944
CTRI/2026/02/102944尚未招募不适用

Development, Validation And Comparative Effectiveness Of A Consensus-Driven Rehabilitation Protocol For Optimizing Tibial Rotation Control In Individuals Following Anterior Cruciate Ligament Reconstruction With Semitendinosus And Gracilis Graft

Abba Sanketh1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2026年7月1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
54
试验地点
1

研究概览

简要总结

This study aims to develop and evaluate a structured physiotherapy rehabilitation program designed to improve knee rotation control following anterior cruciate ligament reconstruction. Participants who have undergone unilateral primary anterior cruciate ligament reconstruction using semitendinosus and gracilis autografts will be randomly allocated to receive either a consensus driven criterion based rehabilitation protocol or a standard institutional rehabilitation protocol. The primary purpose of the study is to compare the effectiveness of the two rehabilitation approaches on internal tibial rotation range of motion and medial to lateral hamstring muscle strength balance over a twelve week intervention period. The study hypothesizes that the structured consensus driven rehabilitation protocol will result in greater improvement in knee rotation control and muscle balance compared to the standard rehabilitation protocol. Outcome assessments will be performed by a blinded assessor at baseline and at predefined follow up time points.

研究设计

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

入排标准

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

入选标准

  • Male adults aged eighteen to forty five years.
  • Participants who have undergone unilateral primary anterior cruciate ligament reconstruction using semitendinosus and gracilis autografts for isolated anterior cruciate ligament injury only without any concomitant meniscal procedures.
  • Medical clearance from the treating arthroscopic surgeon for full participation in rehabilitation and training.
  • No previous history of knee or foot surgery.
  • Participants who are able to understand and read English independently for completing questionnaires administered in English.
  • Participants who provide written informed consent and are willing to comply with follow up assessments and the full duration of the intervention.

排除标准

  • Any concomitant meniscal injury requiring surgical intervention including repair resection or balancing.
  • Primary anterior cruciate ligament reconstruction performed using peroneal graft or bone patellar tendon bone graft.
  • Revision anterior cruciate ligament reconstruction or presence of excessive chondral damage.
  • Multi ligament knee injuries involving medial collateral ligament lateral collateral ligament posterior cruciate ligament or anterolateral ligament or associated rotatory instability patterns requiring additional ligament reconstruction.
  • History of significant injury to the contralateral lower limb.
  • Body mass index more than thirty five.
  • Presence of significant knee osteoarthritis defined as Kellgren Lawrence grade more than two.
  • Presence of neuromuscular disorders affecting lower limb function.
  • Pre existing flatfoot or flexible pes planus defined by a navicular drop more than ten millimeters.
  • Contraindications to testing or exercise including acute infection.
  • Generalized ligamentous laxity defined as Beighton score five or more out of nine.
  • Presence of congenital or acquired lower leg deformities other than tibial rotation.
  • Leg length discrepancy more than two centimeters.

研究者

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

Abba Sanketh

Sri Ramachandra Institute of Higher Education and Research

研究点 (1)

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