Effect of THERA-Trainer Lyra Gait Training in Addition to Physical Therapy on the Mobility of Geriatric Rehabilitation Inpatients Compared to Physical Therapy Alone: Randomized, Active-controlled, Parallel Group, Intervention Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Change in gait velocity
研究概览
简要总结
This study evaluates the effect of the addition of gait training to physical therapy on the gait of geriatric rehabilitation inpatients. Half of the patients will receive gait training with a gait training machine and conventional physical therapy in combination, the other half of the patients will receive conventional physical therapy alone.
详细描述
The geriatric rehabilitation inpatients recruited for this study primarily have difficulties with muscle weakness and walking generally due to a prolonged period of bed rest (as opposed to patients who primarily have cognitive disorders or neurological diseases), generalized muscle weakness and deconditioning. The rehabilitation goal for these patients is to be discharged home (not institutionalized) with improved mobility. Geriatric patients require intensive training in order to reach their pre-hospital levels of mobility and physical functional performance. Usual care involves physical therapy sessions, generally six times per week. Regaining mobility is crucial for quality of life and functional independence.
The aim of this intervention trial is to compare the effectiveness of Lyra gait training plus conventional physical therapy (intervention group) on gait compared to conventional physical therapy alone (control group) in geriatric rehabilitation patients. We hypothesize that, post-intervention, the intervention group will have better mobility and physical functional performance than the control group. Trial results will provide physical therapists and rehabilitation physicians with valuable information to better treat their inpatients and more efficiently use the limited time available for inpatient physical therapy sessions. Specifically, physical therapists should be better able to determine if the benefit of the Lyra gait trainer for geriatric rehabilitation inpatients with primarily muscle deconditioning is strong enough to warrant their extra time investment of providing the Lyra gait training. Results should also help determine in the future if the target population should continue with outpatient therapy after their discharge home. If this trial supports our hypothesis, then the trial results will provide data needed for the sample size calculation for a subsequent, larger trial.
The THERA-Trainer Lyra (from Ability AG, distributed by medica Medizintechnik GmbH) is an automated gait trainer with adjustable body weight support (no exoskeleton) and adjustable pedals (not a treadmill) that move in a physiological gait pattern derived from natural human walking movements. The upright position and the repetitive movement patterns activate muscle memory and allow safe gait training at the individual's performance limit throughout rehabilitation. The Lyra gait training is used to regain walking ability, improve gait speed, improve endurance and improve the gait pattern in geriatric rehabilitation patients.
Ten patients should be enrolled in this study:
Intervention group (n=5): Lyra gait training thrice weekly and conventional physical therapy (6 times per week) during inpatient period. After discharge home, continuation of thrice weekly Lyra gait training and discontinuation of physiotherapy.
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
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •65 years of age or older
- •Rehabilitation inpatients at Felix Platter Hospital with primarily muscle weakness and difficulty walking
- •Community-dwellers before hospital admission with planned discharge home
- •Body weight 150 kg or less
- •Body height between 100 cm and 195 cm
- •Mini-Mental State Examination score 21 points or more
- •Signed informed consent for study participation
排除标准
- •Clinically significant neurologic or musculoskeletal diseases which severly affect walking, e.g. advanced Parkinson's disease or hemiplegia
- •Severe cardiac insufficiency
- •Advanced chronic pulmonary disease (COPD Gold IV)
- •Amputations of extremities (except missing fingers)
- •Blindness
- •Inability to understand and speak German well enough to understand the patient information, training and assessment instructions
研究组 & 干预措施
Intervention Group
Gait training with the THERA-Trainer Lyra (3x/week) in addition to conventional geriatric rehabilitation physical therapy (6x/week) during inpatient period. After discharge home, continuation of Lyra gait training (3x/week), discontinuation of physical therapy.
干预措施: Gait training with the THERA-Trainer Lyra (Other)
Intervention Group
Gait training with the THERA-Trainer Lyra (3x/week) in addition to conventional geriatric rehabilitation physical therapy (6x/week) during inpatient period. After discharge home, continuation of Lyra gait training (3x/week), discontinuation of physical therapy.
干预措施: Physical therapy (Other)
Control Group
Conventional geriatric rehabilitation physical therapy (6x/week) during inpatient period. After discharge home, discontinuation of physical therapy.
干预措施: Physical therapy (Other)
结局指标
主要结局
Change in gait velocity
时间窗: Baseline, after 2 weeks, after 4 weeks
Habitual, preferred ("normal") walking speed (cm/s) quantified with the GAITRite electronic walkway system
次要结局
- Change in spatial-temporal gait parameters (other than walking velocity)(Baseline, after 2 weeks, after 4 weeks)
- Change in subjective intensity of the Lyra training(Baseline, after 2 weeks, after 4 weeks)
- Change in general mobility(Baseline, after 2 weeks, after 4 weeks)
- Change in functionality (DEMMI total score, absolute values)(Baseline, after 2 weeks, after 4 weeks)
- Change in fear of falling(Baseline, after 2 weeks, after 4 weeks)
- Change in the THERA-Trainer Lyra machine settings(Baseline, after 2 weeks, after 4 weeks)
- Change in functionality (DEMMI total score, scaled values)(Baseline, after 2 weeks, after 4 weeks)
- Change in grip strength(Baseline, after 2 weeks, after 4 weeks)
- Change in endurance(Baseline, after 2 weeks, after 4 weeks)