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A Physiotherapy Intervention Study in Patients With Amyotrophic Lateral Sclerosis (ALS)

NCT07341984 · Cantonal Hospital of St. Gallen
In plain English

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Official title
Individualized Physiotherapy Addressing Patient-Specific Deficits in Amyotrophic Lateral Sclerosis Compared to Usual Care Physiotherapy: A Prospective, Pseudorandomized, Controlled, Interventional Study
About this study
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.
Eligibility criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Study design
Enrollment target: 38 participants
Allocation: randomized
Masking: none
Age groups: child, adult, older_adult
Timeline
Starts: 2025-12-16
Estimated completion: 2028-12-15
Last updated: 2026-01-15
Interventions
Other: Individualized Physiotherapy
Primary outcomes
  • Climbing stairs (ALSFRS-R [amyotrophic lateral sclerosis functional rating scale - revised] - item 9: score range 0 to 4 with 4 indicating normal function) (6 months)
Sponsor
Charlotte Vogt · other
Contacts & investigators
ContactCharlotte Vogt · contact · charlotte.vogt@h-och.ch · 0041714943581
ContactOleksandra Hoptar · contact · oleksandra.hoptart@h-och.ch · 0041714943581
All locations (1)
ALS ClinicRecruiting
Sankt Gallen, Switzerland
A Physiotherapy Intervention Study in Patients With Amyotrophic Lateral Sclerosis (ALS) · TrialPath