Background: Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease, as the limitations of drug therapies, there is an increasing focus on a rehabilitation approach that includes Physical training (PT) and Tuina therapy. This study aims to investigate the protective effects of PT and Tuina therapy on physical function, Lung function, and quality of life in patients with ALS.
Methods: This study is a randomized controlled trial. Patients will be divided into an experimental group or control group at a 1:1 ratio, with each group will both have oral Riluzole. The experimental group will conduct PT and Tuina therapy for 4 weeks, while patients in the control group will be instructed to perform basic stretching exercises of the upper and lower limbs at home for 4 weeks. The ALS Functional Rating Scale-Revised scores (ALSFRS-R), Manual muscle test (MMT), Modified Ashworth spasm scale (MAS), Forced vital capacity (FVC), Vital capacity (VC), Forced expiratory volume in one second (FEV1), FEV1/FVC, Peak expiratory flow (PEF), and Maximal voluntary ventilation (MVV), ALS Assessment Questionnaire (ALSAQ-40) scores) and safety measures will be collected at baseline, after 4 weeks, and during follow-ups every 6 months for 2 years.
Discussion: This study will provide evidence-based medical corroboration for the clinical application of Physical training incorporating Tuina therapy in Patients with ALS and promote the development and application of this Comprehensive early rehabilitation.
Trial registration: Chinese clinical trial registry, ChiCTR2300068650. Date: 2023-02-27. https://www.chictr.org.cn/showproj.html?proj=186359