Effects of a Provision of a Cane on Locomotion and Social Participation of Individuals With Stroke: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Walking speed
研究概览
简要总结
Previous studies failed to determine the real effects of the provision of a walking cane after a stroke, mainly due to biases related to their methodological designs. In addition, there is no information on the carry-over effects of a cane to social participation. This study will test the hypothesis that the provision of a cane is effective in improving walking speed, step length, cadence, walking capacity, walking confidence, and participation of individuals with chronic stroke. For this prospective, single-blinded, randomized clinical trial, people after stroke will be randomly allocated into either experimental or control groups. The experimental group will receive a single-point cane, with ergonomic handgrip, which will be individually adjusted to the participant's height. A physiotherapist will provide instructions on how to walk with the cane and the participants will practice for about 15 minutes or until they feel comfortable with the device. Then, they will take the cane home and will be instructed to use it all the time during locomotion. Weekly, they will receive a phone call, to ensure that they are using the cane and to clarify any doubts. A home visit may be conducted, if necessary. The control group will be instructed to perform stretching of the lower limb muscles daily and keep their daily activities, without the use of a cane. To ensure the level of attention similar to that of the participants in the experimental group, the individuals in the control group will also receive weekly phone calls. At baseline (Week 0), post intervention (Week 4), and one month after the cessation (Week 8) of the interventions, researchers blinded to group allocations will collect all outcome measures.
详细描述
Rationale: Motor impairments after a stroke are disabling and interfere with the performance of daily activities, such as locomotion. Walking devices, such as a single cane, are usually prescribed to increase safety and improve gait ability. Previous studies failed to determine the real effects of the provision of a walking cane after a stroke, mainly due to biases related to their methodological designs. In addition, there is no information on the carry-over effects of a cane to social participation.
Aim: This study will test the hypothesis that the provision of a cane is effective in improving walking speed, step length, cadence, walking capacity, walking confidence, and participation of individuals with chronic stroke.
Design: For this prospective, single-blinded, randomized clinical trial, people after stroke will be randomly allocated into either experimental or control groups. The experimental group will receive a single-point cane, with ergonomic handgrip, which will be individually adjusted to the participant's height. A physiotherapist will provide instructions on how to walk with the cane and the participants will practice for about 15 minutes or until they feel comfortable with the device. Then, they will take the cane home and will be instructed to use it all the time during locomotion. Weekly, they will receive a phone call, to ensure that they are using the cane and to clarify any doubts. A home visit may be conducted, if necessary.
The control group will be instructed to perform stretching of the lower limb muscles daily and keep their daily activities, without the use of a cane. To ensure the level of attention similar to that of the participants in the experimental group, the individuals in the control group will also receive weekly phone calls. At baseline (Week 0), post intervention (Week 4), and one month after the cessation (Week 8) of the interventions, researchers blinded to group allocations will collect all outcome measures.
Study outcomes: walking speed, step length, cadence, walking capacity, walking confidence, and participation.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •People with stroke will be eligible if they are >6 months after the onset of their first stroke,
- •>20 years of age,
- •Able to walk at least 14 meters, independently, walk with a speed ≤0.8 m/s or less, and
- •Are naïve to use any assistive device.
排除标准
- •Individuals with cognitive impairments, double hemiparesis, or any other non-stroke related conditions.
研究组 & 干预措施
Provision of a cane
The experimental group will receive a single-point cane, with ergonomic handgrip, which will be individually adjusted to the participant's height. A physiotherapist will provide instructions on how to walk with the cane and the participants will practice for about 15 minutes or until they feel comfortable with the device. Then, they will take the cane home and will be instructed to use it all the time during locomotion. Weekly, they will receive a phone call, to ensure that they are using the cane and to clarify any doubts. A home visit may be conducted, if necessary.
干预措施: Provision of a cane (Other)
Control
The control group will be instructed to to perform stretching of the lower limb muscles daily and keep their daily activities, without the use of a cane. They will also receive weekly phone calls, to ensure similar level of attention to that of the the participants in the experimental group.
干预措施: Control (Other)
结局指标
主要结局
Walking speed
时间窗: Baseline (week 0), after intervention (week 4) and one-month follow-up (week 8)
Changes in walking speed, in m/s, assessed by the 10-m Walk Test.
次要结局
- Walking cadence(Baseline (week 0), after intervention (week 4) and one-month follow-up (week 8))
- Walking confidence(Baseline (week 0), after intervention (week 4) and one-month follow-up (week 8))
- Walking step length(Baseline (week 0), after intervention (week 4) and one-month follow-up (week 8))
- Walking capacity(Baseline (week 0), after intervention (week 4) and one-month follow-up (week 8))
- Social Participation(Baseline (week 0), after intervention (week 4) and one-month follow-up (week 8))
研究者
Luci Fuscaldi Teixeira-Salmela
Titular Professor
Federal University of Minas Gerais