The Effect of Personalized Shoe Insole on the Gait of Parkinson's Disease Subjects: A Triple-blind Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Change in Time Up&Go test
研究概览
简要总结
This study aims to assess the efficacy of custom-made shoe insoles, for subjects with Parkinson's Disease (PD).
To do that, a sample of PD subjects has been randomly assigned to an intervention group that will receive the custom-made insoles or a control group that will receive a sham insole without any specific manufacturing.
Both groups will receive Physiotherapy and Occupational Therapy according to PD rehabilitation guidelines.
The principal outcome will be the Time Up&Go test time, secondary outcomes 10 Meters Walking test speed, Berg Balance Scale score, SF12 score, and orthesis liking.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Subjects with Idiopathic Parkinson's Disease;
- •Age > 18 years;
- •Subjects should be in a positive therapeutic window or in the ON phase during the evaluations;
- •Subjects must be able to walk at least 10 meters independently with or without any walking aid.
排除标准
- •Not clinical stable subjects;
- •SUbjects in OFF phase during the evaluations;
- •Other neurological conditions (e.g. stroke, peripheral neuropathies, etc.);
- •Other pathologies that can negatively influence the subject's walking ability (e.g. surgery at the lower limbs in the previous 6 months, important deformities at the lower limbs, etc.)
结局指标
主要结局
Change in Time Up&Go test
时间窗: Baseline, at 10 weeks, and at 16 weeks.
Change from Baseline (without insoles (T0) and with insoles (T1)) Time Up\&Go at 10 weeks (end of outpatient rehabilitation (T2)) and 16 weeks (follow-up (T3))
次要结局
- Change in 10 Meters Walking Test cadence(Baseline, at 10 weeks, and at 16 weeks.)
- Change in Time Up&Go test sit-to-stand time(Baseline, at 10 weeks, and at 16 weeks.)
- Change in Time Up&Go test mid-turning time(Baseline, at 10 weeks, and at 16 weeks.)
- Change in 10 Meters Walking Test stance phase(Baseline, at 10 weeks, and at 16 weeks.)
- Change in 10 Meters Walking Test double support phase(Baseline, at 10 weeks, and at 16 weeks.)
- Change in Short-Form12 score(Baseline, at 10 weeks, and at 16 weeks.)
- Change in Time Up&Go test stand-to-sit time(Baseline, at 10 weeks, and at 16 weeks.)
- Change in 10 Meters walking test Speed(Baseline, at 10 weeks, and at 16 weeks.)
- Change in Berg Balance Scale Score(Baseline, at 10 weeks, and at 16 weeks.)
- Change in Likert scale 4 points(Baseline, at 10 weeks, and at 16 weeks.)
- Change in 10 Meters Walking Test step length(Baseline, at 10 weeks, and at 16 weeks.)
- Change in 10 Meters Walking Test step duration(Baseline, at 10 weeks, and at 16 weeks.)
- Change in 10 Meters Walking Test swing phase(Baseline, at 10 weeks, and at 16 weeks.)
- Change in 10 Meters Walking Test single support phase(Baseline, at 10 weeks, and at 16 weeks.)
- Change in Time Up&Go test end-turning time(Baseline, at 10 weeks, and at 16 weeks.)