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

January 14, 2026 updated by: Charlotte Vogt

Individualized Physiotherapy Addressing Patient-Specific Deficits in Amyotrophic Lateral Sclerosis Compared to Usual Care Physiotherapy: A Prospective, Pseudorandomized, Controlled, Interventional 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Individualized Physiotherapy Group
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
see above
Active Comparator: Usual Care Physiotherapy Group
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
see above

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Climbing stairs (ALSFRS-R [amyotrophic lateral sclerosis functional rating scale - revised] - item 9: score range 0 to 4 with 4 indicating normal function)
Time Frame: 6 months
funcitonal
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charlotte Vogt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 16, 2025

Primary Completion (Estimated)

December 15, 2027

Study Completion (Estimated)

December 15, 2028

Study Registration Dates

First Submitted

January 6, 2026

First Submitted That Met QC Criteria

January 14, 2026

First Posted (Actual)

January 15, 2026

Study Record Updates

Last Update Posted (Actual)

January 15, 2026

Last Update Submitted That Met QC Criteria

January 14, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BASEC 2025-02230

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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