Replacing Canes With an Elasticated Orthotic-garment in Chronic Stroke Patients: The Influence on Gait and Balance. A Series of N-of-1 Trials
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 4
- 主要终点
- Change in Functional Gait Assessment from baseline to post-Intervention (up to 28 weeks)
研究概览
简要总结
This study aims to investigate the effect of an elasticated orthotic garment "Thera Togs" on walking ability and balance in currently cane using chronic stroke subjects (minimum 6 months post stroke) using a series of N-of-1 Trials.
详细描述
Aim: To investigate the effect of replacing canes with an elasticated orthotic-garment on gait and balance in chronic stroke subjects.
Design Experimental, multiple baseline N-of-1 series with an ABC design with randomised period duration.
Participants Four cane using chronic stroke subjects. Interventions Phase A (9-12 weeks) usual cane-walking to establish baseline values; Phase B (9-19 weeks) intervention: orthotic-garment worn throughout the day with maximal cane reduction; Phase C (9-10 weeks) individually determined follow-up: either no walking-aid, orthotic-garment or cane.
Weekly measurement of Outcome Measures for gait and balance function
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
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
- •Chronic stroke (> six months since last stroke)
- •Independent cane walkers. Subjects usually use canes to walk inside (this could be intermittent changing from cane to holding furniture etc.) and always when outside
- •A Mini Mental Score of 22 or above.
排除标准
- •Patients at risk of falling identified as a Berg Balance Score ≤42/56
研究组 & 干预措施
Phase C follow-Up
9-10 weeks individually determined follow-up: subjects determine whether they walk independently (without assistive device) or with the elasticated orthotic-garment (TheraTogs) or with a cane.
Phase A cane walking (assistive walking-device a cane)
9-12 weeks usual cane-walking to establish baseline values. Patients walk with their usual assistive-walking device - a cane.
干预措施: Cane (Device)
Phase B elasticated orthotic-garment - TheraTogs
9-19 weeks : assistive walking-device which is an elasticated orthotic-garment worn throughout the day (product name TheraTogs). Cane use maximally reduced during his period.
干预措施: Elasticated worn orthotic-garment (Device)
结局指标
主要结局
Change in Functional Gait Assessment from baseline to post-Intervention (up to 28 weeks)
时间窗: Post intervention up to 28 weeks (on average 21.5 weeks)
Change of gait function between phases A (baseline) and Phase B (Intervention)
次要结局
- Change in Trunk-sway from baseline to post-Intervention (up to 28 weeks)(Post intervention up to 28 weeks (on average 21.5 weeks))
研究者
Clare Maguire
Principle Investigator
Technical University of Bern