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临床试验/NCT07078526
NCT07078526尚未招募不适用

Comparison of the Effectiveness of the Otago Exercise Program (Oep) and Neuromuscular Exercises on Pain, Functional Status, Postural Control, and Balance in Patients With Knee Osteoarthritis

Riphah International University1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2025年7月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
58
试验地点
1
主要终点
Numeric Pain Rating Scale (NPRS)

研究概览

简要总结

This randomized controlled trial aims to compare the effects of the Otago Exercise Program (OEP) and neuromuscular exercises on pain, functional status, postural control, and balance in patients with knee osteoarthritis (KOA). A total of 58 participants with X-ray confirmed Grade 2-3 KOA will be enrolled from clinical centers in Lahore, Pakistan. Eligible participants will be randomly assigned to either the OEP group or the neuromuscular exercise group. Both groups will receive standardized physiotherapy alongside their respective interventions twice weekly for six weeks. Outcomes including pain (NPRS), functional status (WOMAC), dynamic mobility (TUG), and postural control (mCTSIB) will be measured at baseline, week 3, and week 6. Data will be analyzed to determine which intervention provides greater improvements in pain reduction, functional capacity, mobility, and balance. This study is expected to inform clinical practice by identifying a more effective exercise approach for managing KOA symptoms and enhancing patients' quality of life.

详细描述

Knee osteoarthritis (KOA) is a highly prevalent degenerative joint disease that significantly impairs mobility, functional capacity, and balance, often resulting in increased fall risk and reduced quality of life. Exercise-based interventions are widely recognized as key components of conservative management for KOA, yet comparative evidence for specific programs remains limited.

This randomized controlled trial is designed to compare the effectiveness of the Otago Exercise Program (OEP) and neuromuscular exercises in managing pain, improving functional status, enhancing postural control, and restoring balance in patients with Grade 2-3 knee osteoarthritis.

Eligible participants aged 45-65 years, with confirmed KOA and fulfilling inclusion criteria, will be recruited from multiple clinical centers in Lahore, Pakistan. After providing informed consent, participants will be randomized into two groups using computer-generated allocation with concealed envelopes.

Group A (OEP group) will receive the Otago Exercise Program, which consists of 17 structured exercises targeting lower limb strength and balance. Each session will include a warm-up, exercise circuit, and cool-down, conducted twice per week for six weeks under supervision.

Group B (neuromuscular group) will perform a series of neuromuscular exercises focused on functional, proprioceptive, and balance training. This protocol, also including warm-up and cool-down, will match the frequency and duration of the OEP group.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
45 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adults aged 45 to 65 years
  • •X-ray confirmed Grade 2-3 knee osteoarthritis (Kellgren-Lawrence scale)
  • •NPRS pain score between 3 and 8
  • •TUG score ≥ 14 seconds
  • •Able and willing to participate in twice-weekly sessions for six weeks
  • •Signed informed consent

排除标准

  • •History of heart attack or stroke within the past year
  • •Knee or hip surgery within the past 6 months
  • •Resting systolic blood pressure >160 mmHg or <100 mmHg
  • •Resting diastolic blood pressure >100 mmHg or <60 mmHg
  • •Neurological disorders affecting balance
  • •Current participation in another exercise program
  • •Recent fractures, cancer, or vascular diseases

研究组 & 干预措施

Otago Exercise Program

Experimental

Participants in this arm will receive the Otago Exercise Program (OEP) consisting of 17 structured exercises (5 strengthening and 12 balance/proprioception exercises). Each session includes warm-up and cool-down, and lasts approximately 40 minutes. Sessions will be supervised twice weekly for a total duration of six weeks, in addition to standard physiotherapy (hot pack and gentle stretching).

干预措施: Otago Exercise Program (Other)

Neuromuscular Exercise

Active Comparator

Participants in this arm will receive a structured neuromuscular exercise protocol including functional, proprioceptive, and balance exercises such as side stepping, high knees march, pelvic lifts, bridging with marching, lateral leg step, sit to stand, single leg clock reach, and single leg stand. Each session includes warm-up and cool-down, lasts approximately 40 minutes, and will be supervised twice weekly for six weeks, alongside standard physiotherapy (hot pack and gentle stretching).

干预措施: Neuromuscular Exercise (Other)

结局指标

主要结局

Numeric Pain Rating Scale (NPRS)

时间窗: Baseline, Week 3, Week 6

Pain intensity will be assessed using the Numeric Pain Rating Scale (NPRS), a validated 0-10 scale where higher scores indicate greater pain. Change from baseline to 6 weeks will be analyzed.

次要结局

  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)(Baseline, Week 3, Week 6)
  • Timed Up and Go (TUG)(Baseline, Week 3, Week 6)
  • Modified Clinical Test of Sensory Interaction in Balance (mCTSIB)(Baseline, Week 3, Week 6)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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