跳至主要内容
临床试验/CTRI/2024/01/061488
CTRI/2024/01/061488尚未招募3 期

Eccentric versus Concentric exercises for Quadriceps strengthening in persons who have undergone anterior cruciate ligament reconstruction –Single blinded Randomized Control Trial.

Internal fluid research grant1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年1月22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
60
试验地点
1
主要终点
Muscle Strength: Modified Oxford Scale

研究概览

简要总结

Persons with anterior cruciate ligament injury (ACL) for whom all inside technique ACLR is

planned under Ortho III unit, will be assessed for eligibility and will be included after a

written consent by the Principal investigator. Pre-operative assessment will be done, which

will include assessment of muscle girth using inch tape, muscle strength using Modified

Oxford scale, pain using Visual Analogue Scale (VAS score), active ROM using Goniometer,

Quadriceps Hamstring Index (Q/H index), electrical muscle activity of the hamstring muscle

using surface EMG electrodes and Functional activities using 3 meter hop test, and Lysholm

score. After the initial assessment the subjects will be given a short-term prehab which will

include knee strengthening and range of motion exercises, to continue till the day of surgery

and the rehabilitation protocol will be explained. (APPENDIX -1) To ensure homogeneity,

subjects who have undergone surgery by the same Orthopedic surgeon(Co-investigator) and

his team will be recruited. Following surgery, supervised physiotherapy will be given and all

the patients will be following the rehabilitation protocol from post-operative day 1(POD 1).

On POD 3, assessment of pain, muscle strength and active knee ROM will be done.

Computer generated randomization will be done; sequentially numbered, opaque sealed

envelopes (SNOSE) will be used for allocation concealment and the subjects will be

randomly allocated to one of the two groups from POD 3. Group I will receive eccentric

exercises and Group II will receive concentric exercises for quadriceps strengthening for 2

weeks. In addition, both these groups will be following the exercises of Phase I of the

rehabilitation protocol (Phase I: Immediate Post-operative period, 1 to 2 WEEKS). At the end

of 2nd week reassessment of pain, muscle girth, muscle strength, active ROM and function

will be done.

The subjects will be advised to continue the rehabilitation protocol at home. A follow- up

assessment will be done at 6 months which will include VAS score, Muscle strength,

including Quadriceps Hamstring Index (Q/H index), electrical muscle activity of the

hamstring muscle, muscle girth, knee range of motion and knee function. All evaluations will

be done by a blinded observer. Analysis will be done to find out the effect of Eccentric

exercises versus Concentric exercises in subjects who have undergone ACL Reconstruction.

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 50.00 Year(s)(—)
性别
All

入选标准

  • Moderately active before the injury
  • Concurrent injury to the MCL, Meniscectomy.

排除标准

  • Previous fracture or reconstruction surgery in the lower limb
  • surgery of both the limbs revision surgery, inflammatory disease and other articular disease.
  • Concurrent injury to the PCL, LCL.

结局指标

主要结局

Muscle Strength: Modified Oxford Scale

时间窗: 1. At Baseline | 2. Post-op day 3 | 3. 2 weeks Post-op | 4. 6 months follow-up

次要结局

  • a) Muscle Bulk: Using inch tape the measurement is taken 15 cm proximal to the(superior pole of the patella.)

研究者

发起方
Internal fluid research grant
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Merlyn R

Christian Medical College, Vellore

研究点 (1)

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