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临床试验/CTRI/2022/10/046797
CTRI/2022/10/046797已完成不适用

Effect of early weight bearing program with conventional physiotherapy on functional outcomes in surgically treated proximal tibia fracture-A Pilot Randomized Controlled Trial.

MGM Institute of physiotherapy1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年10月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
1. Pain

研究概览

简要总结

Objective:

1.To compare the effect of early weight bearing in addition to conventional post-operative rehabilitation versus restricted weight bearing along with conventional physiotherapy on pain, range of motion, quadriceps isometric muscle strength & patient relevant outcomes in patients with post-operative tibial plateau fractures at various intervals i.e. at discharge, after 6 weeks and 12 weeks after the surgery.

  1. To investigate the effect of early weight bearing on functional outcomes of pain, range of motion, quadriceps isometric muscle strength and patient relevant outcomes in patients with postoperative tibial plateau fractures at various intervals i.e. at discharge, after six weeks and 12 weeks compared to baseline.

  2. To investigate the effect of restricted weight bearing on functional outcomes of pain, range of motion, quadriceps isometric muscle strength and patient relevant outcomes in patients with postoperative tibial plateau fractures at various intervals i.e. at discharge, after six weeks and 12 weeks compared to baseline.

  3. To observe the adverse effects, (fixation failure, loss of reduction or joint depression, non- union) of early weight bearing on patients with postoperatively managed tibial plateau fracture.

Design: A Pilot Randomized Controlled Trial

Study Setting: Tertiary Care Hospital

Procedure:

Patients with Post-operative Day 3 of tibial plateau fractures above the age of 18 years will be taken. Eligible patients will be included for the study. Patients will be divided in two groups Group I Weight bearing and Group II Restricted weight-bearing group. Before collection of the data Informed written and verbal consent will be taken from all the patients. Assessment of Knee joint including pain intensity by NPRS and Range of Motion using universal goniometer, quadriceps isometric muscle strength by push-pull dynamometer, Knee Injury and Osteoarthritis Outcome Score (KOOS), post-operative X-ray will be checked on post-operative Day-3 and will be reassessed at discharge , after 6 weeks and after 12 weeks. Adherence will be checked after 6 weeks and 12 weeks by Exercise Adherence Rating Scale (EARS). Group I will be given Early weight bearing along with conventional physiotherapy whereas Group II will be given restricted weight bearing along with conventional physiotherapy.

Early weight bearing Protocol:

Day 3 – Till Discharge: Patient will be made to walk for 10m in a hallway. Partial weight bearing will be given with touchdown weight bearing (as tolerated by the patient) and will be increased by 25% approximately as tolerated by the patient with the use of assistive aid.

Discharge - 6 weeks: Patient will be asked to continue the weight bearing as tolerated and progress to partial weight bearing (50%) as tolerated with the use of assistive aid.

6 weeks – 12 weeks: Patient will be asked to progress from partial weight bearing as tolerated to partial weight bearing up to 75% with the use of assistive aid.

Conventional Physiotherapy Protocol:

These will include bedside exercises consisting of improving range of motion, increasing strength with progression to balance training.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • •Patients with proximal tibial fractures that are managed with open reduction and internal fixation (ORIF).
  • •Patients with Type 1,2,3 tibial plateau fractures (Schatzker classification).
  • •Operated cases with stable condition and recommended for physiotherapy by the operating surgeon on Day 3.

排除标准

  • •Patients having associated Neuro-vascular injury.
  • •Patients having associated fractures of upper limb or multiple lower limb
  • •Pathological fractures secondary to malignancy or infection.
  • •History of Osteoporosis / post-menopausal women
  • •BMI more than 30.

结局指标

主要结局

1. Pain

时间窗: 20 minutes

2. Range of motion

时间窗: 20 minutes

3. Functional

时间窗: 20 minutes

次要结局

  • 1. Quadriceps isometric muscle strength.(2. Adherence.)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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