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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-16

Study Completion Date

2028-12-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Amyotrophic Lateral Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Individualized Physiotherapy

Intervention Type OTHER

see above

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.

Group Type ACTIVE_COMPARATOR

Individualized Physiotherapy

Intervention Type OTHER

see above

Interventions

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Individualized Physiotherapy

see above

Intervention Type OTHER

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No