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临床试验/NCT06963892
NCT06963892已完成不适用

Examining the Effect of Neuromuscular Exercises on Movement Control in Hip & Knee Osteoarthritis: A Randomised Proof of Concept and Feasibility Study

University of Southampton1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2023年7月18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
90
试验地点
1
主要终点
Change in movement control measured by the Short Hip and Lower Limb Movement Screen (Short-HLLMS)

研究概览

简要总结

This completed study evaluated the effects of a six-week neuromuscular exercise programme on movement control in individuals with hip and/or knee osteoarthritis (OA). The trial also assessed the feasibility of conducting a future definitive randomised controlled trial.

A total of 90 participants with symptomatic hip or knee OA were recruited from NHS outpatient physiotherapy clinics and cluster-randomised to either an intervention group or a control group. The intervention group received a structured neuromuscular exercise programme based on the GLA:D® approach, delivered once weekly for six weeks. The control group received usual care, including general physiotherapy advice and standard exercises.

The primary outcome was change in movement control, assessed using the Short Hip and Lower Limb Movement Screen (Short-HLLMS) at baseline and six weeks. Secondary outcomes included joint-specific function measured by KOOS-12 and HOOS-12 questionnaires, and pain intensity assessed using the Numeric Pain Rating Scale (NPRS). Feasibility measures included recruitment rate, participant adherence, and study retention.

The study was completed successfully and demonstrated that neuromuscular exercise may improve short-term movement control and functional outcomes in individuals with OA. Feasibility outcomes supported the acceptability of the intervention and the procedures for conducting a future large-scale trial.

详细描述

Osteoarthritis (OA) is a chronic joint condition that significantly impacts mobility, function, and quality of life. Although exercise is strongly recommended in clinical guidelines for managing OA, the specific role of neuromuscular training-exercises targeting sensorimotor control, functional movement patterns, and joint stability-has not been thoroughly investigated in terms of improving movement control in this population. Previous research indicates that compromised neuromuscular control may contribute to altered biomechanics, increased joint loading, pain, and functional limitations among people with OA. However, structured neuromuscular interventions aiming explicitly at enhancing movement control remain understudied in clinical practice.

This study addressed this gap by conducting a cluster-randomised, proof-of-concept and feasibility trial designed to evaluate the effects of a structured neuromuscular exercise intervention based on principles from the Good Life with osteoArthritis in Denmark (GLA:D®) programme. This exercise programme has previously shown benefits in reducing OA symptoms and improving function, but its effect on movement control using structured assessments has yet to be explored.

Participants with clinically diagnosed symptomatic hip or knee OA were recruited from NHS physiotherapy outpatient clinics in the United Kingdom. Following recruitment, study sites were cluster-randomised to either the intervention or control group to minimise cross-group contamination. Participants at sites allocated to the intervention group underwent a supervised, structured neuromuscular exercise programme delivered by trained physiotherapists. This programme involved six supervised sessions, conducted once per week, with each session lasting approximately 60 minutes. Each session comprised a brief educational component followed by exercises focusing on dynamic joint stability, functional movement retraining, proprioception, balance, and muscle strengthening.

The neuromuscular exercises were progressively adjusted to individual abilities and pain tolerance, with careful monitoring of participants to ensure exercises were performed safely and correctly. Training intensity and exercise difficulty gradually increased throughout the intervention period, adhering closely to the established protocol from the GLA:D® programme.

Participants at control sites received standard physiotherapy care typically provided to individuals with hip or knee OA within the NHS. This standard care included general joint mobility exercises, strength training, general physiotherapy advice, and education provided during routine outpatient appointments.

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 (Participant)

入排标准

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

入选标准

  • •Adults aged 30 years or older.
  • •Clinically diagnosed symptomatic hip and/or knee osteoarthritis (unilateral or bilateral).
  • •Meeting the American College of Rheumatology (ACR) clinical criteria for osteoarthritis.
  • •Able to safely participate in neuromuscular exercises and movement screening tests.

排除标准

  • •Acute septic arthritis.
  • •Inflammatory arthritis (e.g., rheumatoid arthritis).
  • •Avascular necrosis of the hip or knee.
  • •Recent steroid injections (within the past 3 months).
  • •Knee or hip surgery within the previous 12 months.
  • •Significant cardiorespiratory or systemic disorders limiting exercise participation.
  • •Neurological conditions (e.g., stroke, Parkinson's disease, multiple sclerosis).
  • •Body mass index (BMI) greater than 35 kg/m².
  • •Severe low back pain restricting activity.
  • •Cognitive impairment affecting ability to follow study instructions.
  • •Skin conditions affecting lower limbs, preventing safe participation in exercises.
  • •Inability to communicate effectively in English or understand the consent information.

研究组 & 干预措施

Neuromuscular Exercise Intervention

Experimental

Participants attended six supervised group exercise sessions over six weeks. Each session (~60 min) included structured neuromuscular exercises focusing on joint stability, functional movement retraining, balance, proprioception, and muscle strengthening, following principles from the Good Life with osteoArthritis in Denmark (GLA:D®) programme. Exercises were progressed based on individual capability and pain tolerance.

干预措施: Neuromuscular Exercise Programme (GLA:D®-based (Behavioral)

Usual Physiotherapy Care

Active Comparator

Participants received usual care provided by NHS physiotherapy outpatient services. This involved standard joint mobility exercises, strengthening activities, general advice, and education typically offered to patients with hip or knee osteoarthritis, without specific emphasis on structured neuromuscular control training.

干预措施: Usual Physiotherapy Care (NHS Standard) (Behavioral)

结局指标

主要结局

Change in movement control measured by the Short Hip and Lower Limb Movement Screen (Short-HLLMS)

时间窗: Baseline (pre-intervention) and at 6 weeks (post-intervention)

The Short Hip and Lower Limb Movement Screen (Short-HLLMS) was used to objectively assess participants' movement control, alignment, and joint stability. The screen evaluated three functional tasks: small knee bend, standing hip flexion, and deep squat. Lower scores indicate better movement quality and control. Assessments were performed at baseline (pre-intervention) and immediately following the six-week intervention period (post-intervention). The primary outcome measure was the change in Short-HLLMS scores from baseline to six weeks.

次要结局

  • Change in Knee-specific Function (KOOS-12)(Baseline (pre-intervention) and at 6 weeks (post-intervention))
  • Change in Hip-specific Function (HOOS-12)(Baseline (pre-intervention) and at 6 weeks (post-intervention))
  • Change in Pain Intensity (Numeric Pain Rating Scale)(Baseline (pre-intervention) and at 6 weeks (post-intervention))
  • Feasibility of the Intervention (Recruitment and Retention Rates)(Measured continuously during recruitment and across the 6-week intervention period)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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