Influence of Medial Wedge Corrective Insoles Versus Sham Insoles on Gait Characteristics in Persons After Total Hip Replacement - Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Mean change from baseline in osteoarthritis-specific symptoms and physical functional disability according to Lequesne OA index on 12 weeks
研究概览
简要总结
The study will test the hypothesis, that the use of medial wedge insoles in people participating in comprehensive rehabilitation between 1-6 months after total hip replacement, and not having a varus deformity of the knee or symptomatic arthrosis of the medial knee compartment, will improve patient's functioning, the symmetry of gait and stance compared to persons using sham insoles.
The participants will undergo a 6-week program of in-patient rehabilitation aimed at: pharmacologic and non-pharmacologic pain management, improvement of vascular function, cardiopulmonary function, functions of skeletal muscles, range of motion and stability of peripheral joints, gait function, body position. The rehabilitation program will also address individual needs with psychotherapy and vocational therapy.
The study will help to identify correlations between gait parameter change and functional improvement during the rehabilitation following THR.
Study participants will be provided with individually made corrective medial wedge insoles or sham insoles and instructed to use them during gait training and everyday activities.
Functional parameters will be examined at the study entry, at the end of 6 weeks of intervention, and 6 weeks following discharge.
详细描述
Principal indications for total hip replacement (THR) include hip arthritis - degenerative or inflammatory (91%), fractures of femoral neck (5%), avascular necrosis (2%) and hip dysplasia (2%). Weight-bearing exercises (including treadmill training) are important to improve both impairment and ability to function.
Rationale of testing the effect of medial wedge insoles after THR:
Valgus deformity of the lower limb and insufficiency of the gluteus medius muscle lead to femoral adduction. In patients after a total hip replacement (THR), it will transfer the ground force to the prosthesis cup in the adduction position.
The application of corrective insoles is a simple, inexpensive, and non-invasive intervention that may be easily integrated into daily activities to promote health benefits, provide comfort, and prevent acute and chronic injuries, as well as correct biomechanical deficiencies in the musculoskeletal system (including valgus knee ). An important effect of the insoles is to support the preferred movement pattern and, as a result, reduce unnecessary muscle activity in gait, and decrease fatigue and energy expenditure. The use of insoles can therefore be a valuable addition to gait function exercises. Typically, hindfoot corrective insoles are used with a wedge that corrects the heel between 5-15 degrees. Smaller correction wedge angles are unable to correct the valgus moment and affect the center of pressure (CoP) projection during walking, while wedges with a larger correction angle cause discomfort.[5] Medial wedge insoles increase heel inversion, reduce internal tibial rotation, transfer the CoP medially to the knee joint, and increase the knee and hip abduction moment.
Insufficiency of the gluteus medius muscle causing pelvic descent and internal rotation of the thigh is typical for hip arthritis, especially after THR using the posterior, posterolateral, or direct lateral approach. It was found that the use of medial wedge insoles promotes the activation of the gluteus medius during dynamic activities, although Bird et al. did not confirm this effect in people with low back pain.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Participants are provided with either active or shame medical devices. Care providers (rehabilitatin team members) and outcome assessors are not acknowledged about patiens' allocation
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of primary or secondary hip coxarthrosis or proxmal hip facture
- •Total Hip replacement made from posterior or lateral surgical approaches
- •Total Hip replacement made less 1-6 months prior to study entry
排除标准
- •Total Hip replacement made from anterior or anterolateral approach
- •Total Hip replacement made less than 1 month or more than 6 months prior to study entry
- •Varus knee (Q angle below 5 degrees in males and below 10 degrees in females
- •Symptomatic arthritis of medial compartment of the knee
- •Use of corrective insoles (excluding insoles for limb length discrepancy compensation)
- •Inability to walk for one minute
- •Neurologic conditions
- •History of hip prosthesis dislocation
- •Cognitive dysfunction (MoCa Score below 26)
- •Lack of shoes with a stiff heel counter
结局指标
主要结局
Mean change from baseline in osteoarthritis-specific symptoms and physical functional disability according to Lequesne OA index on 12 weeks
时间窗: At baseline and on 12 week
Lequesne OA index is a self-reported instrument assessing osteoarthritis-specific symptoms and physical functional disability. The results are presented on a numeric scale between 0 (no symptoms, full physical functioning) and 24 (extremely intensive symptoms and the worst functioning). Change: (week 12 score - baseline score)
Mean change from baseline in pain according to Pain Rating Scale by the British Pain Society on numeric rating scales at 12 weeks
时间窗: At baseline and on 12 week
Pain Rating Scale by the British Pain Society, the Polish version; © The British Pain Society 2006 is a self-reported instrument assessing pain intensity (now and on average last week), distress produced by pain (now and on average last week) and interference of pain with everyday activities. The result is presented on five numeric rating scales ranging from 0 (no pain/distress/interference) to 10 (worst possible pain/distress/interference). Change: (week 12 score - baseline score)
Mean change from baseline in pain, stiffness, and physical functional disability according to Western Ontario and McMaster Universities - WOMAC scale on 12 weeks
时间窗: At baseline and on 12 week
WOMAC scale is a self-reported instrument assessing pain, stiffness, and physical functional disability . The results are presented on a numeric scale between 0 (no symptoms, full physical functionning) and 96 (extremely intensive symptoms, extreme disability). Change: (week 12 score - baseline score)
次要结局
- Mean change from baseline in time of maximum force exerted by heel symmetry on 12 weeks(At baseline and on 12 week)
- Mean change from baseline in range of motion of lower extremities on 6 weeks(At baseline and on 6 week)
- Mean change from baseline in step time symmetry on 12 weeks(At baseline and on 12 week)
- Mean change from baseline in foot rotation symmetry on 6 weeks(At baseline and on 6 week)
- Mean change from baseline in step length symmetry on 12 weeks(At baseline and on 12 week)
- Mean change from baseline in range of motion of lower extremities on 12 weeks(At baseline and on 12 week)
- Mean change from baseline in time of maximum force exerted by forefoot symmetry on 12 weeks(At baseline and on 12 week)
- Mean change from baseline in time of maximum force exerted by midfoot symmetry on 6 weeks(At baseline and on 6 week)
- Mean change from baseline in voluntary gait speed on 6 weeks(At baseline and on 6 week)
- Mean change from baseline in voluntary gait speed on 12 weeks(At baseline and on 12 week)
- Mean change from baseline in time of load change heel to forefoot symmetry on 6 weeks(At baseline and on 6 week)
- Mean change from baseline in time of load change heel to forefoot symmetry on 12 weeks(At baseline and on 12 week)
- Mean change from baseline in Centre of Pressure path length in stance on 6 weeks(At baseline and on 6 week)
- Mean change from baseline in step time symmetry on 6 weeks(At baseline and on 6 week)
- Mean change from baseline in time of maximum force exerted by forefoot symmetry on 6 weeks(At baseline and on 6 week)
- Mean change from baseline in time of maximum force exerted by heel symmetry on 6 weeks(At baseline and on 6 week)
- Mean change from baseline in step length symmetry on 6 weeks(At baseline and on 6 week)
- Mean change from baseline in time of maximum force exerted by midfoot symmetry on 12 weeks(At baseline and on 12 week)
- Mean change from baseline in step width on 6 weeks(At baseline and on 6 week)
- Mean change from baseline in step width on 12 weeks(At baseline and on 12 week)
- Mean change from baseline in the length of gait line marked out by the centre of pressure displacement on walking symmetry on 12 weeks(At baseline and on 12 week)
- Mean change from baseline in the single limb support line marked out by the centre of pressure displacement on walking symmetry on 6 weeks(At baseline and on 6 week)
- Mean change from baseline in lateral deviation of the center of pressure on 6 weeks(At baseline and on 6 week)
- Mean change from baseline in lateral deviation of the center of pressure on 12 weeks(At baseline and on 12 week)
- Mean change from baseline in anteroposterior deviation of the center of pressure on 6 weeks(At baseline and on 6 week)
- Mean change from baseline in anteroposterior deviation of the center of pressure on 12 weeks(At baseline and on 12 week)
- Mean change from baseline in foot rotation symmetry on 12 weeks(At baseline and on 12 week)
- Mean change from baseline in the length of gait line marked out by the centre of pressure displacement on walking symmetry on 6 weeks(At baseline and on 6 week)
- Mean change from baseline in the single limb support line marked out by the centre of pressure displacement on walking symmetry on 12 weeks(At baseline and on 12 week)
- Mean change from baseline in 95% confidence ellipse area marked up by the Centre of Pressure displacement in stance on 12 weeks(At baseline and on 12 week)
- Mean change from baseline in the ratio of average forces exerted by operated leg in comparison to non-operated leg during stance on 6 weeks(At baseline and on 6 week)
- Mean change from baseline in Centre of Pressure path length in stance on 12 weeks(At baseline and on 12 week)
- Mean change from baseline in 95% confidence ellipse area marked up by the Centre of Pressure displacement in stance on 6 weeks.(At baseline and on 6 week)
- Mean change from baseline in the ratio of average forces exerted by operated leg in comparison to non-operated leg during stance on 12 weeks(At baseline and on 12 week)
- User's satisfaction with insoles(On 12 week)
- Mean change from baseline in osteoarthritis-specific symptoms and physical functional disability according to Lequesne OA index on 6 weeks(At baseline and on 6 week)
- Mean change from baseline in pain according to Pain Rating Scale by the British Pain Society on numeric rating scales at 6 weeks(At baseline and on 6 week)
- Mean change from baseline in pain, stiffness, and physical functional disability according to Western Ontario and McMaster Universities - WOMAC scale on 6 weeks(At baseline and on 6 week)