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

NCT07341984 | Recruiting

• 1 other identifier: BASEC 2025-02230
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Amyotrophic Lateral Sclerosis

Outcome Measures

Primary Outcomes (1)

• Climbing stairs (ALSFRS-R [amyotrophic lateral sclerosis functional rating scale - revised] - item 9: score range 0 to 4 with 4 indicating normal function)

  funcitonal

  6 months

Study Arms (2)

Individualized Physiotherapy Group

EXPERIMENTAL

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

Other: Individualized Physiotherapy

Usual Care Physiotherapy Group

ACTIVE COMPARATOR

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

Other: Individualized Physiotherapy

Interventions

Individualized Physiotherapy OTHER

see above

Individualized Physiotherapy Group; Usual Care Physiotherapy Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charlotte Vogt: lead

Study Sites (1)

ALS Clinic

Sankt Gallen, 9007, Switzerland

RECRUITING

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Charlotte Vogt

CONTACT

0041714943581; charlotte.vogt@h-och.ch

Oleksandra Hoptar

CONTACT

0041714943581; oleksandra.hoptart@h-och.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: January 6, 2026
• First Posted: January 15, 2026
• Study Start: December 16, 2025
• Primary Completion (Estimated): December 15, 2027
• Study Completion (Estimated): December 15, 2028
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)