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临床试验/NCT06943079
NCT06943079已完成不适用

Effects of Hold-relax Technique With or Without Blood Flow Restriction on Pain, Range of Motion and Functional Disability in Patients With Post Operative ACL Rehabilitation.

Riphah International University1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2024年2月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
48
试验地点
1
主要终点
1- BFR Cuff

研究概览

简要总结

A randomized controlled trial investigated the effects of Hold Relax Technique (HRT) with and without Blood Flow Restriction (BFR) on pain, range of motion (ROM), and functional disability in patients with post-operative ACL rehabilitation. This study includes all types of genders with age limit is 25-45 years. But the aim is to infer the answers to the following questions; Does HRT has better effects than HRT with BFR? How much effect should be noted ? The research will show that if both HRT and HRT with BFR groups had significant pain reduction, the HRT with BFR group demonstrated greater ROM improvement and significant enhancement in functional ability compared to the HRT and control groups.

详细描述

A randomized clinical trial will be conducted under Riphah International University guidelines and nonprobability convenient sampling will be used to collect data from the 48 participants from the Ghurki trust and teaching hospital setting. Participants will go through ACL reconstruction specifically the usage of a hamstring graft. The participants were allocated into two groups by using randomization through computer-generated software A and B. In A group only HRT will be applied to check the effects on pain, ROM, and functional disability. In the B group HRT with BFR will be utilized to note the effects on pain, ROM, and functional disability.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
25 Years 至 45 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age group 25-45 years.
  • •Both gender male and female.
  • •Patient underwent arthroscopic ACL repair procedure.
  • •Patients in 6 weeks of rehabilitation phase.
  • •Grafts of hamstring muscle were used in repair.
  • •Max range achieved after post-op day
  • •Low- moderate pain intensity.

排除标准

  • •Any form of bone carcinoma.
  • •Any Post-OP active infectionous Patients.
  • •Any circulatory effects.
  • •DVT and pulmonary embolism.
  • •Loose Implant placement.
  • •Non co-operative Patient.
  • •Hyperasthetic Patient.
  • •Polytraumatic Post-OP Patient.

研究组 & 干预措施

A - Hold Relax technique with Blood Flow Restriction technique

Experimental

Effects of Hold Relax technique with Blood Flow Restriction on functional outcome

干预措施: Effect of Hold Relax technique with Blood Flow Restriction technique on functional outcome (Device)

B - Hold relax technique without blood Flow Restriction technique

Active Comparator

Effect of Hold Relax technique without Blood flow restriction on functional outcomes

干预措施: Effect of Hold Relax technique without Blood Flow Restriction technique on functional outcomes (Other)

结局指标

主要结局

1- BFR Cuff

时间窗: 6 weeks

BFR requires a tourniquet to be placed on a limb. The cuff needs to be tightened to a specific pressure that occludes venous flow while still allowing arterial flow whilst exercises are being performed. Simple pieces of equipment such as surgical tubing or elastic straps have been used in gym settings to achieve this result. These are not advisable as you are unable to monitor the amount of blood flow occlusion. A thin diameter may also cause too much local pressure and result in tissue damage.(29)

2- UNIVERSAL GONIOMETER

时间窗: 6 weeks

The measurement of joint range of motion (ROM), also referred to as goniometry, is a crucial physical therapy practice.(30) Goniometry, the measuring of joint angles, is a frequently used assessment tool in the tracking of rehabilitation interventions as well as issues with the musculoskeletal system. It is generally performed with a universal goniometer (UG).(31) Inter-tester reliability for universal goniometers is mediocre.(32)

3- NUMERIC PAIN RATING SCALE (NPRS)

时间窗: 6 weeks

The Numeric Pain Rating Scale (NRS-11) is an eleven-point rating system with a score of 0 representing no pain at all and a score of 10 representing the greatest agony the patient has ever had. In this context, the NPRS-11 pain severity score of "4" is usually given particular weight, indicating that it may serve as a threshold value for pain severity in clinical practice.(33) Its dependability coefficient is high (0.95-0.96).(34)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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