Gait Analysis as a Measure of Physical Performance in Managing Bilateral Knee Osteoarthritis in Elderly People
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Physical performance - gait analysis
研究概览
简要总结
The investigators perform a prospective controlled study and assess gait parameters in bilateral knee osteoarthritis (KOA) elderly patients with wireless system - BTS G-WALK, pre- and post-rehabilitation program. The complete assessment include: ultrasound exam, gait parameters and functional scale.
The investigators investigate the real impact of complete rehabilitation program, with gait control, on the physical performance and functional status.
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 (Investigator)
入排标准
- 年龄范围
- 65 Years 至 80 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •participants older than 65 years diagnosed with KOA according to ACR criteria, also accepted in our country;
- •at least 5 years of disease progression;
- •painful knee for a period of 48 hours after physical activity;
- •absence of knee injuries at least 6 months before;
- •absence of major disturbances in the frontal plane alignment of the knee;
- •participants with other co-morbidities, but well controlled, like: arterial hypertension, dyslipidaemia and mellitus diabetes type II; a history of a symptomatic or complicated upper gastro-intestinal ulcer;
- •compliance with physical exercise during the healthcare program.
排除标准
- •unstable medical conditions preventing the patient from participating in the rehabilitation programs,
- •history of knee replacement,
- •neurological or any other conditions affecting strength or function of lower limbs.
研究组 & 干预措施
Study Group
Experimental: Study Group. Elderly participants diagnosed with bilateral KOA will receive complete rehabilitation program (10 sessions of electrotherapy measures - transcutaneous nerve stimulation, ultrasound and low intensity laser treatment; 6 weeks of kinetic measures and gait training). Previous, all participants will be complete gait clinical, ultrasound and functional assess.
干预措施: Ultrasound exam of quadriceps muscles (left/right) and gait analysis (Other)
Study Group
Experimental: Study Group. Elderly participants diagnosed with bilateral KOA will receive complete rehabilitation program (10 sessions of electrotherapy measures - transcutaneous nerve stimulation, ultrasound and low intensity laser treatment; 6 weeks of kinetic measures and gait training). Previous, all participants will be complete gait clinical, ultrasound and functional assess.
干预措施: Electrotherapy measures: transcutaneous nerve stimulation, ultrasound and low intensity laser; each one daily , applied on both lower limbs, for 10 days. Kinetic measures daily (Other)
Study Group
Experimental: Study Group. Elderly participants diagnosed with bilateral KOA will receive complete rehabilitation program (10 sessions of electrotherapy measures - transcutaneous nerve stimulation, ultrasound and low intensity laser treatment; 6 weeks of kinetic measures and gait training). Previous, all participants will be complete gait clinical, ultrasound and functional assess.
干预措施: Gait training (Other)
Control Group
Active Comparator: Control Group Control Group will receive only 10 sessions of electrotherapy (transcutaneous nerve stimulation, ultrasound and low intensity laser treatment) and 6 weeks of kinetic measures, without gait control training. Previous, all participants will be complete clinical gait, ultrasound and functional assess.
干预措施: Ultrasound exam of quadriceps muscles (left/right) and gait analysis (Other)
Control Group
Active Comparator: Control Group Control Group will receive only 10 sessions of electrotherapy (transcutaneous nerve stimulation, ultrasound and low intensity laser treatment) and 6 weeks of kinetic measures, without gait control training. Previous, all participants will be complete clinical gait, ultrasound and functional assess.
干预措施: Electrotherapy measures: transcutaneous nerve stimulation, ultrasound and low intensity laser; each one daily , applied on both lower limbs, for 10 days. Kinetic measures daily (Other)
结局指标
主要结局
Physical performance - gait analysis
时间窗: 3 months
Timed Up-and-Go (TUG) test (seconds) - participants stood up from an armed chair, walked at a safe and comfortable pace to a line 3 m away, crossed the line, turned, and returned to a sitting position in the chair; none of the patients used a walking aid and the time to complete the task was recorded.
次要结局
- Functional status - quality of life(3 months)
研究者
Diana Kamal
PhD
Filantropia Hospital