Robot suit aims to keep ALS patients walking longer

NCT ID NCT06199284

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

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Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing whether a robotic exoskeleton called Atalante can safely help people with ALS maintain their ability to walk. The idea is that the suit provides natural leg movements and feedback to the brain, which may slow down walking decline. About 20 adults with slow-progressing ALS will try the device in a supervised setting. The main goal is to check safety, but researchers will also measure walking speed, balance, and breathing.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2024

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients with amyotrophic lateral sclerosis (defined according to the El Escorial criteria: possible, probable or definite), at the time of diagnosis * Male or female, between 18 and 70 years of age * Slowly and moderately evolving patients ∆ ALS Progression rate (FS) ≤ 1.11 (The ALS progression rate was calculated as follows: (48 - ALSFRS-R at screening visit) / (duration from onset to this visit (month)) (Kimura et al., 2006). ALSFRS-R progression will be classified as slow (∆FS ≤ 0.47), intermediate (0.47 ≤ ∆PR ≤1.11) or fast (∆PR \> 1.11) (Labra et al., 2016). * Manual muscle testing ≥ 3 for deltoid muscle and ≥ 4 for neck flexors and extensors muscles * Ambulatory status: a stable gait deficit with a total score between 3 and 6 on the ALSFRS-R sub-items "walking" and "climbing stairs" * French speaking patient * Patient affiliated with the French social security system * Signed informed consent * Measurements related to the use of the Atalante exoskeleton: * Height between 155 and 190 cm * Weight \< 90 kg * Pelvis width \< 46 cm in seated position * Thigh length between 56.8 and 64.8 cm * Leg length \> 45.7cm or less than: * 60.7cm if ankle dorsi flexion is ≥16° * 57.7cm if ankle dorsi flexion is ≥13°and \<16° * 56.7cm if ankle dorsi flexion is\>10°and ≤13° * 55.7cm if ankle dorsi flexion is ≥ 0°and ≤10° * Joint amplitudes of lower limbs : * Hip: flexion 90°, extension 5°, medial rotation 10°, lateral rotation 20°, abduction 17°, adduction 10° * Knee: flexion 5-110° * Ankle: dorsiflexion (knee straight) 0°, plantarflexion 9°, eversion18°, inversion 18°. Exclusion Criteria: * Osteoporosis at the femoral and/or lumbar level (T score ≤ -2.5), confirmed by bone densitometry at both the femoral and lumbar sites. * Pressure ulcers in areas of contact with the exoskeleton * Severe spasticity (greater than Ashworth 3) for adductor, hamstring, quadriceps and sural triceps muscles or uncontrolled clonus * Cardiac or respiratory contraindications to physical effort * Cognitive impairment that can affect comprehension * Pregnancy or attempted pregnancy

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

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  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hôpital Pitié-Salpêtrière

    Paris, 75013, France

  • Institut de myologie

    Paris, 75013, France

  • Station Debout

    Paris, 75001, France

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