Kaohsiung Veterans General Hospital , Kaohsiung, Taiwan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- The change of stride length (meter) of parameters of gait cycle.
研究概览
简要总结
Many patients after acute stage of stroke present with abnormal gait pattern due to weakness or hypertonicity of the affected limbs.
Ambulation training with the use of visual feedback strategy is one of the promising rehabilitation in patients with chronic stroke.
Walking assist device with auxiliary laser illuminator during ambulation training could correct gait parameters, improve balance and basic activity of daily living among stroke patients.
详细描述
Facilitation of normal gait is a primary goal of rehabilitation on patients with stroke. The investigators aimed to investigate whether walking assist device with auxiliary lser illuminator (laser quad-cane) providing visual feedback during ambulation could improve parameters of gait cycle and function among patients with chronic stroke.
Methods: This was a randomized-prospective study and participants were recruited to each the experimental and the control group equally. Patients in the experimental group (EG) received 30-minutes rehabilitation, consisting of 15 minutes of walking training with laser quad-cane and 15 minutes of traditional physical therapy (such as strengthening and balance training). Patients in the control group (CG) received the same rehabilitation except that the walking training was by conventional strategy without lase quad-cane. The rehabilitation lasted for 4 weeks, twice per week. Gait parameters were measured by Rehab watch as primary outcomes and Berg's balance scale (BBS), timed-up-and-go test (TUG), and Barthel index were used as secondary outcomes. Both the primary and secondary outcomes were measured before the rehabilitation (baseline), 4 weeks (week 4), and 8 weeks (week 8) after the rehabilitation.
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 (Outcomes Assessor)
盲法说明
Patients who fulfilled the inclusion and exclusion criteria were randomized (1:1) into two groups, using sequentially numbered, opaque, sealed envelopes (SNOSE) method containing a group assignment number by a person who was not clinically involved in and, therefore, was blinded to this study.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stroke patients at subacute (stroke symptoms between three months to one year) or chronic stage (stroke symptoms more than 1 year)
- •with hemiplegia
- •with sufficient cognition that could follow the instructions and procedure
- •walk independently for a distance of more than 20 meters with or without the use of a walking aid.
排除标准
- •Stroke patients with other neurological diseases like Parkinsonism,
- •Multiple sclerosis
- •Spinal cord injury that might interfere with walking ability
结局指标
主要结局
The change of stride length (meter) of parameters of gait cycle.
时间窗: The study consisted of a screen visit, a baseline visit and follow-up visits at 4 and 8 weeks after the initiation of the study.
The primary outcome was the stride length (meter) of parameters of gait cycle. The parameters of gait cycle were measured by a gait analyzer (Reha-Watch1 system; HASOMED1 GmbH, Magdeburg, Germany). Reha-Watch 1 system is based on inertial sensors that allow the quantitative measurement of the important kinematic variables acceleration and angular velocity. The associated software analyzes the sensor signals and calculates temporal (e.g., stride duration, gait phases) and spatial (e.g., stride length, foot angle) parameters on this basis.
The change of cadence(step/min) of parameters of gait cycle
时间窗: The study consisted of a screen visit, a baseline visit and follow-up visits at 4 and 8 weeks after the initiation of the study.
The primary outcome was the cadence(step/min) of parameters of gait cycle. The parameters of gait cycle were measured by a gait analyzer (Reha-Watch1 system; HASOMED1 GmbH, Magdeburg, Germany). Reha-Watch 1 system is based on inertial sensors that allow the quantitative measurement of the important kinematic variables acceleration and angular velocity. The associated software analyzes the sensor signals and calculates temporal (e.g., stride duration, gait phases) and spatial (e.g., stride length, foot angle) parameters on this basis.
The change of duration of swing phase(%) of parameters of gait cycle
时间窗: The study consisted of a screen visit, a baseline visit and follow-up visits at 4 and 8 weeks after the initiation of the study.
The primary outcome was the duration of swing phase(%) of parameters of gait cycle. The parameters of gait cycle were measured by a gait analyzer (Reha-Watch1 system; HASOMED1 GmbH, Magdeburg, Germany). Reha-Watch 1 system is based on inertial sensors that allow the quantitative measurement of the important kinematic variables acceleration and angular velocity. The associated software analyzes the sensor signals and calculates temporal (e.g., stride duration, gait phases) and spatial (e.g., stride length, foot angle) parameters on this basis.
The change of duration of single support (%) of parameters of gait cycle
时间窗: The study consisted of a screen visit, a baseline visit and follow-up visits at 4 and 8 weeks after the initiation of the study.
The primary outcome was the duration of single support (%) of parameters of gait cycle. The parameters of gait cycle were measured by a gait analyzer (Reha-Watch1 system; HASOMED1 GmbH, Magdeburg, Germany). Reha-Watch 1 system is based on inertial sensors that allow the quantitative measurement of the important kinematic variables acceleration and angular velocity. The associated software analyzes the sensor signals and calculates temporal (e.g., stride duration, gait phases) and spatial (e.g., stride length, foot angle) parameters on this basis.
The change of double support (%)during the gait cycle
时间窗: The study consisted of a screen visit, a baseline visit and follow-up visits at 4 and 8 weeks after the initiation of the study.
The primary outcome was the double support (%)during the gait cycle. The parameters of gait cycle were measured by a gait analyzer (Reha-Watch1 system; HASOMED1 GmbH, Magdeburg, Germany). Reha-Watch 1 system is based on inertial sensors that allow the quantitative measurement of the important kinematic variables acceleration and angular velocity. The associated software analyzes the sensor signals and calculates temporal (e.g., stride duration, gait phases) and spatial (e.g., stride length, foot angle) parameters on this basis.
The change of duration of stance phase(%) of parameters of gait cycle
时间窗: The study consisted of a screen visit, a baseline visit and follow-up visits at 4 and 8 weeks after the initiation of the study.
The primary outcome was the duration of stance phase(%) of parameters of gait cycle. The parameters of gait cycle were measured by a gait analyzer (Reha-Watch1 system; HASOMED1 GmbH, Magdeburg, Germany). Reha-Watch 1 system is based on inertial sensors that allow the quantitative measurement of the important kinematic variables acceleration and angular velocity. The associated software analyzes the sensor signals and calculates temporal (e.g., stride duration, gait phases) and spatial (e.g., stride length, foot angle) parameters on this basis.
The change ofangle between toes and the ground at the time of toe-off during a gait cycle (toe-off angle)
时间窗: The study consisted of a screen visit, a baseline visit and follow-up visits at 4 and 8 weeks after the initiation of the study.
The primary outcome was the angle between toes and the ground at the time of toe-off during a gait cycle (toe-off angle). The parameters of gait cycle were measured by a gait analyzer (Reha-Watch1 system; HASOMED1 GmbH, Magdeburg, Germany). Reha-Watch 1 system is based on inertial sensors that allow the quantitative measurement of the important kinematic variables acceleration and angular velocity. The associated software analyzes the sensor signals and calculates temporal (e.g., stride duration, gait phases) and spatial (e.g., stride length, foot angle) parameters on this basis.
The change ofangle between calcaneus and the ground at the time of heel-strike during a gait cycle (heel-strike angle)
时间窗: The study consisted of a screen visit, a baseline visit and follow-up visits at 4 and 8 weeks after the initiation of the study.
The primary outcome was the angle between calcaneus and the ground at the time of heel-strike during a gait cycle (heel-strike angle). The parameters of gait cycle were measured by a gait analyzer (Reha-Watch1 system; HASOMED1 GmbH, Magdeburg, Germany). Reha-Watch 1 system is based on inertial sensors that allow the quantitative measurement of the important kinematic variables acceleration and angular velocity. The associated software analyzes the sensor signals and calculates temporal (e.g., stride duration, gait phases) and spatial (e.g., stride length, foot angle) parameters on this basis.
次要结局
- Timed up and go test (TUG)(The study consisted of a screen visit, a baseline visit and follow-up visits at 4 and 8 weeks after the initiation of the study.)
- The Berg balance scale (BBS)(The study consisted of a screen visit, a baseline visit and follow-up visits at 4 and 8 weeks after the initiation of the study.)
- Barthel index (BI)(The study consisted of a screen visit, a baseline visit and follow-up visits at 4 and 8 weeks after the initiation of the study.)
研究者
Wan-Yun Huang
Department of Physical Medicine and Rehabilitation
Kaohsiung Veterans General Hospital.