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临床试验/CTRI/2025/11/097586
CTRI/2025/11/097586尚未招募3 期

Proprioceptive Neuromuscular Facilitation for improving shoulder range in immediate post cardiac surgery patients-Single blinded Randomized Controlled Trial

Internal -Fluid Research Grant1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年11月24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
100
试验地点
1

研究概览

简要总结

In this single blinded randomized controlled trial we aim to find out if addition of Proprioceptive Neuromuscular Facilitation (PNF) movement patterns to conventional therapy improves shoulder range of motion shoulder function and reduces pain  when compared to conventional therapy alone in immediate post cardiac surgery patients through median sternotomy.

Persons admitted in cardiothoracic unit for cardiac surgery through median sternotomy will be screened for eligibility by the principal investigator and will be included pre-operatively after a written consent. Baseline assessment will be performed pre-operatively by a physical therapist (PT1) who will be blinded to the group allocation  which will include assessment of shoulder range of motion - external rotation  abduction and flexion using inertial measuring unit (IMU) pain evaluation using Numerical pain rating scale (NPRS) and shoulder functional activity will be evaluated using University of California  Los Angeles (UCLA) Shoulder Rating Score. The UCLA Shoulder Rating Scale which is already part of our outcome measures  includes a specific question assessing patient satisfaction with shoulder function and pain. Hence  this scale will capture both functional improvement and the patient’s subjective satisfaction with recovery. Following cardiac surgery through median sternotomy participants will be randomly allocated to either control or interventional group using sequentially numbered opaque sealed envelopes (SNOSE). Control group will receive 1 week of conventional therapy  which consists of active shoulder range of motion exercises while the interventional group will receive 1 week of PNF shoulder exercise in addition to conventional therapy. The PNF pattern exercises which will be used in this study are D1 Flexion – Extension (diagonal pattern 1) and D2 Flexion – Extension (diagonal pattern 2) of Upper Limb. At the end of 1 week the same outcomes will be re-assessed to find out and compare the effect of PNF pattern exercise  when used in addition to conventional therapy versus conventional therapy alone on range of motion, pain and shoulder function. . Each participant will receive 1 week of supervised therapy in the hospital followed by a home exercise program sheet to continue the prescribed exercises independently. After 3 months participants will return for follow-up assessment  and all outcome measures will be reassessed to evaluate long-term effects. At 3 month follow-up  outcomes will be re- assessed to determine the incidence of adhesive capsulitis in post-operative cardiac patients. Only trained and qualified physiotherapists of the institution will deliver all interventions .

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
19.00 Year(s) 至 65.00 Year(s)(—)

入选标准

  • Age 19 years to 65 years Gender including both male and female Patients who have undergone median sternotomy for cardiac surgery.

排除标准

  • Previous neurological disorders affecting the cervical spine and upper limb Any systemic or inflammatory joint disease of shoulder Previous history of any shoulder fractures Poor Cognitive or mental status.

研究者

发起方
Internal -Fluid Research Grant
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Anna George

Christian Medical College, Vellore

研究点 (1)

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