The Effect of Lower Body Positive Pressure Treadmill Training on Postural Control and Gait Function in Individuals With Chronic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Number of device limitation as assessed by Quebec User Evaluation of Satisfaction with assistive Technology (QUEST)
研究概览
简要总结
Stroke is neurological disease characterized by chronic major disability which will cause permanent changes in individuals life. In Saudi Arabia stroke considered as the main leading of disability and death. It is estimated to be 0.67% in Saudi Arabia compared to 2.5% of the population in the United States (US). Most of individuals have mobility deficit such as walk speed and postural maintenance which lead to increase the risk of fall and decrease activity of daily living (ADL).
Stroke rehabilitation should starts as early as possible to avoid post-stroke complications. Several interventions for stroke rehabilitation to improve mobility deficit and posture control continuously being evaluated. One of the ways of stroke rehabilitation is a using of body weight supported treadmill training (BWSTT). It is a useful tool to facilitate gait training and recovery after neurological injures.
The lower body positive pressure (LBPP) is a treadmill that is enclosed in inflated bag. There is a chamber inside the treadmill that is produce air pressure which is aid in eliminate the uncomfortableness feeling produce by weight bearing during gait. The chamber is supplied with a system provide LBPP aiding in decrease patient weight while walking by giving the patient lifting force from below using air pressure. This helps the patient to walk affectively with minimum weight bearing on the lower extremity.
Therefore, the purpose of the study is to evaluate the feasibility and effectiveness of LBPP on gait function, balance and quality of life in chronic stroke individuals.
The investigators hypothesis that the LBPP will significantly improve gait function, balance, quality of life in chronic stroke patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hemiparesis due to stroke; at least 6 months since the stroke.
- •Independent ambulatory ability with or without assistive device at least 10 meters.
- •Do not have any additional neurological and/or orthopedic deficiencies impairing ambulation.
- •Functional ambulation ≥ 3 on functional ambulation categories
- •No history of cardiac, respiratory, cardiovascular conditions interferes with protocol,
- •Able to understand simple instructions,
- •Able to control the head and trunk posture.
排除标准
- •recurrent stroke,
- •spasticity greater than 3 on modified Ashowrth scale,
- •Ataxia, or tremor of lower limb
结局指标
主要结局
Number of device limitation as assessed by Quebec User Evaluation of Satisfaction with assistive Technology (QUEST)
时间窗: Through study completion, an average of 1 year.
Reporting any device limitation that appear during the study
Participation's safety questionnaire as assessed by numerical rating scale rating from 0 (extremely dissatisfied) - 5 (extremely satisfied).
时间窗: Report the safety at 6 weeks
The safety of the LBPP will be evaluated by the participation's safety questionnaire. The safety will be measured using numerical rating scale rating from 0 (extremely dissatisfied) - 5 (extremely satisfied). The participant will be asked to rate his/her level of satisfaction for safety variable at the end of 6th weeks.
Participation's satisfaction questionnaire include (comfort, dimensions, personal acceptance, and simplicity of use) will be measured using numerical rating scale rating from 0 (extremely dissatisfied) - 5 (extremely satisfied).
时间窗: Report the feasibility at 6 weeks
The feasibility of the LBPP will be evaluated by the participation's satisfaction questionnaire include (comfort, dimensions, personal acceptance, and simplicity of use) will be measured using numerical rating scale rating from 0 (extremely dissatisfied) - 5 (extremely satisfied). The participant will be asked to rate his/her level of satisfaction for each variable at the end of 6th weeks.
Number of participants who have adverse event as assessed by CTCAE v4.0
时间窗: Through study completion, an average of 1 year.
Reporting the presence (or absence) of adverse events
Number of sessions
时间窗: Through study completion, an average of 1 year.
Reporting the number of sessions for each participant.
次要结局
- gait function as assessed by 10MWT(Change from baseline gait at 6 weeks.)
- Balance function(Change from baseline balance at 6 weeks.)
- Quality of life as assessed by (Short Form 36)(Change from baseline quality of life at 6 weeks.)
研究者
Sattam Almutairi
Assistant professor
Qassim University