amyotrophic lateral sclerosis
Conditions
Interventions
the treatment group:Botulinum toxin An injection therapy
Sponsors
The People's Hospital of China Three Gorges University.The First People's Hospital of Yichang
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. diagnosis of possible or definite ALS according to the revised ElEscorial criteria. 2. using the Medical Research Council (MRC) scale to assess the target muscle strength MRC >= 4, and the gait impaired but still standing (with the highest lower limb score of 8 in the total ALSFRS-R score). 3. using the modified Ashworth score (mAs) to evaluate moderate to severe lower limb spasm (LL) mAs >= 2, and gait interference with ankle clonus or Achilles tendon contracture. 4. the mild disease progression rate (?FS), measured as ?FS1= (48-ALSFRS-R at recruitment)\ duration from onset to injection (month) < 0.5.
Exclusion criteria
Exclusion criteria: 1. other diseases with spasms (such as stroke, Parkinson's, etc.). 2. according to the ultrasonic evaluation, there was no fibrous degeneration in the spastic muscle, so it was not suitable for botulinum toxin A injection. 3. stop taking oral antispasmodic drugs for less than one month, or are using other drugs that act on neuromuscular junctions (such as quinine, aminoglycoside antibiotics, azithromycin, morphine, etc.). 4. FVC 4 years, age less than 18 years or more than 70 years old. 6. bulbar involvement such as dyspnea or dysphagia. 7. those who are allergic to botulinum toxin An or refuse to sign an informed consent form for botulinum toxin A injection treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CSS;10WMT; | — |
Secondary
| Measure | Time frame |
|---|---|
| Barthel scale;the mild disease progression rate (?FS); | — |
Countries
China
Contacts
Public ContactYunhong Zha
The People's Hospital of China Three Gorges University/ The First People's Hospital of Yichang
Outcome results
None listed