Lower Body Positive Pressure Treadmill Training in Post-Stroke Gait Impairment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Functional Ambulatory Categories
研究概览
简要总结
Lower body positive pressure (LBPP) decreases weight bearing and ground reaction forces, with potentially positive effects on qualitative gait indices. However, which gait features are shaped by LBPP gait training in post-stroke patients is still poorly predictable. A pilot study on the effects of LBPP gait training on qualitative and quantitative gait indices in patients with hemiparesis due to stroke in the chronic phase was carried out. Twenty-five patients who suffered from a first, single, ischemic, supra-tentorial stroke occurred at least 6 months before study inclusion were provided with 24 daily sessions of LBPP treadmill gait training using AlterG device. These patients were compared with 25 age-matched healthy controls (HC), who were formerly provided with the same amount of AlterG training, and 25 patients with the same clinical-demographic characteristics of the first group of patients, who previously underwent conventional treadmill gait training (TGT). Qualitative and quantitative gait features, including Functional Ambulation Categories, gait cycle features, and muscle activation patterns were analyzed before and after the training (AlterG or TGT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age ≥ 55 years;
- •first, single, ischemic supra-tentorial stroke occurred at least 6 months before the study inclusion;
- •a Functional Ambulatory Categories (FAC) score of >2;
- •ability to control head and trunk posture;
- •no systemic or cardiovascular contraindication to LBPP
排除标准
- •Medical and/or psychiatric illness potentially interfering with the treatment.
研究组 & 干预措施
Alter G treatment
All participants practiced one session a day of AlterG (for 40min), six days a week, for four weeks (for a total amount of 24 sessions). All patients were trained using BWS, and treadmill speed (S) to allow the participant to walk with the intermittent support of one physiotherapist to help with balance and coordination. A qualitative (using FAC) and quantitative (spatio-temporal parameters and dynamic electromyography) gait assessment before and after the end of the gait training was performed.
干预措施: AlterG Treatment (Device)
Traditional Gait Training
All participants practiced one session a day TGT (for 40min), six days a week, for four weeks (for a total amount of 24 sessions). All patients were trained using FAC-tailored physiotherapist assistance, to allow the participant to walk with the intermittent support of one physiotherapist to help with balance and coordination (FAC 2), with the visual supervision of one physiotherapist (FAC 3), or independently without using the handrails (FAC 4). Physiotherapist assistance, and S were checked and adapted to subjects' progresses across the AlterG sessions.
干预措施: AlterG Treatment (Device)
Healthy Control
ll participants practiced one session a day of AlterG (for 40min), six days a week, for four weeks (for a total amount of 24 sessions). All patients were trained using BWS, and treadmill speed (S) to allow the participant to walk with the intermittent support of one physiotherapist to help with balance and coordination. A qualitative (using FAC) and quantitative (spatio-temporal parameters and dynamic electromyography) gait assessment before and after the end of the gait training was performed.The HC initially practiced the device at the same BWS and S administered to the patients. BWS and S were reduced progressively and increased, respectively, across the AlterG sessions in keeping with patients progresses.
干预措施: AlterG Treatment (Device)
结局指标
主要结局
Functional Ambulatory Categories
时间窗: 1 month
FAC is a functional walking test that evaluates ambulation ability. This 6-point scale assesses ambulation status by determining how much human support the patient requires when walking, regardless of whether or not they use a personal assistive device
次要结局
- gait cycle duration(1 month)
研究者
Rocco Salvatore Calabrò
Clinical Professor
IRCCS Centro Neurolesi "Bonino-Pulejo"