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

Charlotte Vogt

Status: Enrolling

Conditions: Amyotrophic Lateral Sclerosis

Treatments: Other: Individualized Physiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07341984

BASEC 2025-02230

Details and patient eligibility

About

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.

Enrollment: 38 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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38 participants in 2 patient groups

Individualized Physiotherapy Group

Experimental group

Description:

This group receives an individualized physiotherapy program tailored to patient-specific functional deficits. Two thrids of participants are allocated to the intervention group.

Treatment:

Other: Individualized Physiotherapy

Usual Care Physiotherapy Group

Active Comparator group

Description:

This group continues to receive usual care physiotherapy in accordance with standard clinical practice. One third of participants are allocated to the control group.

Treatment:

Other: Individualized Physiotherapy