Amyotrophic Lateral Sclerosis/Motor Neuron Disease
Conditions
Interventions
Integrated Chinese and Western medicine treatment (Part I):Basic treatment + Chinese medicine diagnosis and treatment + Chinese and Western medicine rehabilitation combined treatment
Non-Western and Chinese medicine integrated treatment (Part I):Basic treatment + Chinese medicine treatment only
Non-Western and Chinese medicine integrated treatment (Part I):Basic treatment + Western medical treatment only
Consecutive group entry (Part II Phase I):None
ALS Recovery Alliance (Part II Phase II):Integrated support intervention plus family resilience intervention
ALS Recovery Alliance (Part II Phase II):Routine Care
Sponsors
Hubei Provincial Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Part I: (1) Patients aged 18-80 years, regardless of gender; (2) Meet Gold Coast diagnostic criteria, disease stage 1-4, and severity grading 1-4; 2. Part II Phase I: (1) Patient inclusion criteria: 1) Patients diagnosed with ALS by Gold Coast criteria; 2) Patients aged 18-80 years, regardless of gender; 3) Patients with normal interpretative and expressive abilities and no other serious mental illness; 4) Voluntary participation in this study, and family members agreed to participate. (2) Patient's family members inclusion criteria: 1) Being the primary caregiver of the patient during treatment; 2) have normal understanding of expression. 3) Completed at least 3 time points of follow-up assessment in the Phase I longitudinal study. 4) Voluntary participation in this study. 3. Part II Phase II: (1) Patient inclusion criteria; 1) Patients with a confirmed diagnosis of ALS; 2) Patients with normal comprehension and expression and no other serious mental illness; 3) Voluntary participation in this study, and family members agree to the patient's participation; (2) Inclusion criteria for patient's family members: 1) being the primary caregiver of the patient during treatment; 2) Normal comprehension and expression ability; 3) Voluntary participation in this study.
Exclusion criteria
Exclusion criteria: 1. Part I: (1) Patients diagnosed with other neurodegenerative diseases during the trial; (2) Patients with severe psychiatric or cognitive disorders and other diseases who cannot cooperate to complete the stud; (3) Patients with comorbid heart, brain, liver, kidney and other organ diseases. 2. Part II: Same exclusion criteria as Phase I.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effective survival;Family Resilience; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Disease progression rate;Basic motion function;Quality of life;Depression;Weight;BMI;Intervention time for supplementary feeding;Assisted breathing intervention time;Incidence of Adverse Events;Fatigue;Sleep quality;Patient general condition questionnaire;Hospitalization Questionnaire;General physical examination;Laboratory Metrics;Lung function indicators;Electromyography;Imaging;Family Adaptability and Cohesion;Resilience;Caregiver Burden;Positive Aspects of Caregiver;Perceived Stress;Herth Hope;Social Support;Well-Being Index;Financial burden;Caregiver General Information; | — |
Countries
China
Contacts
Public ContactChen Gang
Hubei University of Chinese Medicine
Outcome results
None listed