Individualized Physiotherapy Addressing Patient-Specific Deficits in Amyotrophic Lateral Sclerosis Compared to Usual Care Physiotherapy: A Prospective, Pseudorandomized, Controlled, Interventional Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Climbing stairs (ALSFRS-R [amyotrophic lateral sclerosis functional rating scale - revised] - item 9: score range 0 to 4 with 4 indicating normal function)
研究概览
简要总结
This study investigates whether an individualized physiotherapy program, tailored to each patient's specific motor deficits, can better support physical function compared with usual care physiotherapy in people with ALS.
The individualized program is guided by diagnostic assessments using a robotic leg press system, which helps identify strengths and weaknesses in muscle function and movement control.
Participants will receive either individualized physiotherapy or standard physiotherapy and will be followed for 12 months. The aim of the study is to improve physiotherapy strategies for people with ALS in a safe and patient-centered manner.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of clinically probable, probable laboratory-supported, or definite ALS (revised El Escorial criteria) or upper motor neuron only (OPM classification [onset, propagation, motoneuron involvement])
- •age ≥18 years; ability to understand study information and provide written informed consent
- •Willingness and ability to perform individualized exercise according to the study protocol (approximately three to five sessions of 30 minutes per week) for the duration of the intervention period
- •Individuals of all sexes and gender identities are eligible for inclusion
排除标准
- •pregnancy, tracheostomy, continuous assisted ventilation, or other significant non-ALS pulmonary disease
- •other neurodegenerative or neuromuscular conditions that may confound assessments
- •concomitant life-threatening disease or impairment interfering with functional assessment
结局指标
主要结局
Climbing stairs (ALSFRS-R [amyotrophic lateral sclerosis functional rating scale - revised] - item 9: score range 0 to 4 with 4 indicating normal function)
时间窗: 6 months
funcitonal
次要结局
未报告次要终点
研究者
Charlotte Vogt
Sponsor-Investigator
Cantonal Hospital of St. Gallen