ALS - Amyotrophic Lateral SclerosisEXALSNCT06199284
Atalante Exoskeleton in the Rehabilitation of Patients With Amyotrophic Lateral Sclerosis
A study testing Atalante exoskeleton in people with ALS - Amyotrophic Lateral Sclerosis, run by Institut de Recherche sur la Moelle épinière et l'Encéphale at 3 sites in France.
Trial summary
Using a MRI gait motor imagery paradigm in ALS patients in order to study how ALS affects the function of the central neural networks involved in gait function, we showed a reorganization of the motor networks that represents a compensatory response to the dysfunction of the networks involved in gait function. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- ALS - Amyotrophic Lateral Sclerosis
- What is being tested?
- Atalante exoskeleton
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesFrance
- Study dates
- 31 Jan 2024to 29 Jan 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 22Show fewer
- 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°.
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
France3 sites
Station Debout
Paris, 75001
Hôpital Pitié-Salpêtrière
Paris, 75013
Institut de myologie
Paris, 75013
About this study
Official title: Safety and Efficacy of the Atalante Exoskeleton in the Rehabilitation of Patients With Amyotrophic Lateral Sclerosis: Study Protocol for an Open, Uncontrolled Interventional Study, EXALS.
Using a MRI gait motor imagery paradigm in ALS patients in order to study how ALS affects the function of the central neural networks involved in gait function, we showed a reorganization of the motor networks that represents a compensatory response to the dysfunction of the networks involved in gait function. Our main hypothesis is that by providing coherent proprioceptive input to the sensorimotor integration areas, gait training with an exoskeleton may boost compensatory network reorganization and help to maintain function. We hypothesize that this can be achieved through a locomotion training strategy that reproduces normal gait motor patterns and appropriate sensory feedback. Gait training with an exoskeleton can meet these needs. The Atalante exoskeleton offers unique potential thanks to its cutting-edge technological features, hands-free functions and availability in numerous centers across Europe. Evaluation of its safety and efficacy in ALS is of the utmost interest in order to generalize this new approach in ALS.
Read the detailed description
Current research is mainly focused on evaluating the effect of robotic rehabilitation on locomotion in ALS. In order to understand this approach, it is important to validate its safety and to determine patient's experience with this new rehabilitation concept in ALS. In this study, we aim to evaluate the safety, the participant experience and effectiveness of the training program with the Atalante exoskeleton as a gait training tool for ALS patients, compared with usual care, on walking ability, functional capacity and other symptoms associated with motor disability. The Atalante exoskeleton is the only self-balancing exoskeleton that enables assisted walking without walking aid, reproducing a natural walking pattern and multidirectional movement. EXALS is an interventional, monocentric, prospective, open trial. With a limited number of studies on gait rehabilitation exoskeletons in ALS, this study represents a significant scientific contribution, being the first to explore the benefits of a self-balancing exoskeleton with a rigorous design. In addition to robust outcome measures, this study places importance on participants' perception, motivation, and involvement in decision-making, adding depth and strength to the research.
- Conditions
- ALS - Amyotrophic Lateral Sclerosis
- Being tested
- Atalante exoskeleton
- Keywords
- Atalante exoskeleton, Gait training, Amyotrophic lateral sclerosis, Rehabilitation, Robotics
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atalante exoskeletonDevice
The gait training program using Atalante exoskeleton consisted of 3 sessions per week for 6 weeks. Each session includes the patient's installation and de-installation (10 min), walking training (30 min), and physical activities at the end of the session where the patient is in an upright position in the exoskeleton (e.g. badminton, boxing, or basketball) (5-10 min). For each participant, the assistance of the exoskeleton can be specifically adjusted and can be set symmetrically or asymmetrically bases on his capabilities.
| Study group | Role | What they receive |
|---|---|---|
| Patient | Other | Single-group study following an ABA design:
Phase A1 (usual care for 6 weeks) Phase B (usual care + gait training using exoskeleton for 6 weeks) Phase A2 (usual care for 6 weeks) All participants undergo the same sequence of conditions according to the protocol. Receives: Device: Atalante exoskeleton |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of Atalante exoskeleton
Monitoring adverse events
Measured: During the three consecutive phases of the study (A1, B, and A2), from baseline (Week 0) through Week 18, with assessments at Weeks 0, 3, 6, 9, 12, 15, and 18 and during all training sessions in phase B
Secondary outcomes (16)
Functional capacity
ALSFRS-R
Measured: During the three consecutive phases of the study (A1, B, and A2), from baseline (Week 0) through Week 18, with assessments at Weeks 0, 3, 6, 9, 12, 15, and 18 (7 assessments in total)
Pulmonary function
Forced vital capacity
Measured: During the three consecutive phases of the study (A1, B, and A2), from baseline (Week 0) through Week 18, with assessments at Weeks 0, 3, 6, 9, 12, 15, and 18 (7 assessments in total)
Gait ability
The 6-minute walk test, the 10-meter walk test and the Timed Up and Go test
Measured: During the three consecutive phases of the study (A1, B, and A2), from baseline (Week 0) through Week 18, with assessments at Weeks 0, 3, 6, 9, 12, 15, and 18 (7 assessments in total)l
Static and dynamic balance
Berg Balance Scale (0 - 56) with higher scores representing better balance
Measured: During the three consecutive phases of the study (A1, B, and A2), from baseline (Week 0) through Week 18, with assessments at Weeks 0, 3, 6, 9, 12, 15, and 18 (7 assessments in total)
Speed of movement of the center of pressure per second
Force platform
Measured: During the three consecutive phases of the study (A1, B, and A2), from baseline (Week 0) through Week 18, with assessments at Weeks 0, 3, 6, 9, 12, 15, and 18 (7 assessments in total)
Lower limb muscle strength
Isometric dynamometer
Measured: During the three consecutive phases of the study (A1, B, and A2), from baseline (Week 0) through Week 18, with assessments at Weeks 0, 3, 6, 9, 12, 15, and 18 (7 assessments in total)
Spasticity of knee flexor and extensor muscles
Instrumental assessment with isokinetic dynamometer
Measured: During the three consecutive phases of the study (A1, B, and A2), from baseline (Week 0) through Week 18, with assessments at Weeks 0, 3, 6, 9, 12, 15, and 18 (7 assessments in total)
Patient quality of life
ALSAQ-40
Measured: During the three consecutive phases (A1, B, and A2), with assessments at baseline (Week 0), Week 6, Week 12, and Week 18 (4 assessments in total)
General fatigue
Fatigue Severity Scale and the Modified Fatigue Impact Scale
Measured: During the three consecutive phases (A1, B, and A2), with assessments at baseline (Week 0), Weeks 3, 6, 12, and 18 (5 assessments in total).
Patient pain
Brief pain inventory-short form
Measured: During the three consecutive phases (A1, B, and A2), with assessments at baseline (Week 0), Week 6, Week 12, and Week 18 (4 assessments in total).
Anxiety and depression
Hospital anxiety and depression scale
Measured: During the three consecutive phases (A1, B, and A2), with assessments at baseline (Week 0), Week 6, Week 12, and Week 18 (4 assessments in total).
Intrinsic motivation
Intrinsic motivation inventory
Measured: week 12
Subjective impact of gait training with Atalante exoskeleton on participants
The participant's experience with domain-oriented exoskeleton training
Measured: week 12
Participants' attitudes to Atalante gait training
Net promoter score
Measured: week 12
Efficacy and interactivity of the Atalante exoskeleton
A specific questionnaire was developed to assess the efficacy and interactivity of the Atalante exoskeleton
Measured: Week 12
Participants' experience of gait training with Atalante exoskeleton
Semi-structured interview
Measured: week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start31 Jan 2024
- Primary completion30 Sep 2026 (estimated)
- Study completion29 Jan 2027 (estimated)
Why it stopped: Recruitment is suspended due to funding issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for ALS - Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study will be conducted in 3 phases, each lasting 6 weeks, following the ABA procedure. Phase B represents the intervention phase, during which patients will practice their gait training at a rhythm of 3 sessions/week, as an add-on to usual care. In the two phases A, patients receive usual care with no additional treatment
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut de Recherche sur la Moelle épinière et l'Encéphale
- Sponsor type
- University, hospital or other
- Collaborators
- Association pour la Recherche sur la Sclérose Latérale Amyotrophique et autres Maladies du Motoneurone, Groupe Hospitalier Pitie-Salpetriere, Institut de Myologie, France, Station Debout, Laboratory of Biomedical Imaging
- Responsible party
- Sponsor
- Investigators
- Ghida TRAD, PhD, Study chair, Sorbonne Université, Inserm, CNRS, Laboratoire d'Imagerie Biomédicale (LIB), 75006-Paris (France), Neuromuscular Physiology and Evaluation Lab, Neuromuscular Investigation Center, Institute of Myology, 75013-Paris (France)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06199284
- Sponsor's protocol ID
- 2023-A00553-42
- Acronym
- EXALS
- Status last verified
- Jan 2026
- First submitted
- 29 Dec 2023
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after de-identification, may be made available upon reasonable request from the corresponding author. Data sharing will be subject to institutional and ethical approvals.
Publications
Labra J, Menon P, Byth K, Morrison S, Vucic S. Rate of disease progression: a prognostic biomarker in ALS. J Neurol Neurosurg Psychiatry. 2016 Jun;87(6):628-32. doi: 10.1136/jnnp-2015-310998. Epub 2015 Jul 7.
PubMed 26152368Kimura F, Fujimura C, Ishida S, Nakajima H, Furutama D, Uehara H, Shinoda K, Sugino M, Hanafusa T. Progression rate of ALSFRS-R at time of diagnosis predicts survival time in ALS. Neurology. 2006 Jan 24;66(2):265-7. doi: 10.1212/01.wnl.0000194316.91908.8a.
PubMed 16434671Abidi M, de Marco G, Grami F, Termoz N, Couillandre A, Querin G, Bede P, Pradat PF. Neural Correlates of Motor Imagery of Gait in Amyotrophic Lateral Sclerosis. J Magn Reson Imaging. 2021 Jan;53(1):223-233. doi: 10.1002/jmri.27335. Epub 2020 Sep 7.
PubMed 32896088Trad G, Lenglet T, Ledoux I, Querin G, Blancho S, Marchand-Pauvert V, Hogrel JY, Pradat PF. Safety, feasibility and preliminary effects of Atalante exoskeleton-assisted gait training in amyotrophic lateral sclerosis: a prospective ABA pilot study. J Neuroeng Rehabil. 2026 Jul 1. doi: 10.1186/s12984-026-02046-y. Online ahead of print.
PubMed 42387593Trad G, Lenglet T, Ledoux I, Querin G, Blancho S, Marchand-Pauvert V, Pradat PF, Hogrel JY. Exploring the interplay between quantitative muscle strength, functional performance, and patient-reported outcomes in amyotrophic lateral sclerosis: a cross-sectional pilot study. Sci Rep. 2026 Apr 24;16(1):18813. doi: 10.1038/s41598-026-45898-z.
PubMed 42026110Trad G, Lenglet T, Ledoux I, Querin G, Blancho S, Marchand-Pauvert V, Hogrel JY, Pradat PF. Safety and efficacy of the Atalante exoskeleton in the rehabilitation of French patients with amyotrophic lateral sclerosis: a prospective, monocentric, open, uncontrolled, interventional protocol, EXALS. BMJ Open. 2026 Jan 16;16(1):e109620. doi: 10.1136/bmjopen-2025-109620.
PubMed 41545051
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of the Atalante Exoskeleton in the Rehabilitation of Patients With Amyotrophic Lateral Sclerosis: Study Protocol for an Open, Uncontrolled Interventional Study, EXALS.
- ClinicalTrials.gov ID
- NCT06199284
- Acronym / sponsor ID
- EXALS / 2023-A00553-42
- Conditions
- ALS - Amyotrophic Lateral Sclerosis
- Keywords
- Atalante exoskeleton, Gait training, Amyotrophic lateral sclerosis, Rehabilitation, Robotics
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Recruitment is suspended due to funding issues
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Institut de Recherche sur la Moelle épinière et l'EncéphaleUniversity, hospital or other
- Collaborators
- Association pour la Recherche sur la Sclérose Latérale Amyotrophique et autres Maladies du Motoneurone, Groupe Hospitalier Pitie-Salpetriere, Institut de Myologie, France, Station Debout, Laboratory of Biomedical Imaging
- Study start
- 31 Jan 2024 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 29 Jan 2027 (estimated)
- First posted
- 10 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Using a MRI gait motor imagery paradigm in ALS patients in order to study how ALS affects the function of the central neural networks involved in gait function, we showed a reorganization of the motor networks that represents a compensatory response to the dysfunction of the networks involved in gait function. Our main hypothesis is that by providing coherent proprioceptive input to the sensorimotor integration areas, gait training with an exoskeleton may boost compensatory network reorganization and help to maintain function. We hypothesize that this can be achieved through a locomotion training strategy that reproduces normal gait motor patterns and appropriate sensory feedback. Gait training with an exoskeleton can meet these needs. The Atalante exoskeleton offers unique potential thanks to its cutting-edge technological features, hands-free functions and availability in numerous centers across Europe. Evaluation of its safety and efficacy in ALS is of the utmost interest in order to generalize this new approach in ALS.
Detailed description
Current research is mainly focused on evaluating the effect of robotic rehabilitation on locomotion in ALS. In order to understand this approach, it is important to validate its safety and to determine patient's experience with this new rehabilitation concept in ALS. In this study, we aim to evaluate the safety, the participant experience and effectiveness of the training program with the Atalante exoskeleton as a gait training tool for ALS patients, compared with usual care, on walking ability, functional capacity and other symptoms associated with motor disability. The Atalante exoskeleton is the only self-balancing exoskeleton that enables assisted walking without walking aid, reproducing a natural walking pattern and multidirectional movement. EXALS is an interventional, monocentric, prospective, open trial. With a limited number of studies on gait rehabilitation exoskeletons in ALS, this study represents a significant scientific contribution, being the first to explore the benefits of a self-balancing exoskeleton with a rigorous design. In addition to robust outcome measures, this study places importance on participants' perception, motivation, and involvement in decision-making, adding depth and strength to the research.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study will be conducted in 3 phases, each lasting 6 weeks, following the ABA procedure. Phase B represents the intervention phase, during which patients will practice their gait training at a rhythm of 3 sessions/week, as an add-on to usual care. In the two phases A, patients receive usual care with no additional treatment
| Arm | Type | Receives |
|---|---|---|
| Patient | Other | Device: Atalante exoskeletonSingle-group study following an ABA design: Phase A1 (usual care for 6 weeks) Phase B (usual care + gait training using exoskeleton for 6 weeks) Phase A2 (usual care for 6 weeks) All participants undergo the same sequence of conditions according to the protocol. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- 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"
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atalante exoskeletonThe gait training program using Atalante exoskeleton consisted of 3 sessions per week for 6 weeks. Each session includes the patient's installation and de-installation (10 min), walking training (30 min), and physical activities at the end of the session where the patient is in an upright position in the exoskeleton (e.g. badminton, boxing, or basketball) (5-10 min). For each participant, the assistance of the exoskeleton can be specifically adjusted and can be set symmetrically or asymmetrically bases on his capabilities. | Device | Patient |
Primary outcome
Safety of Atalante exoskeleton
Time frame: During the three consecutive phases of the study (A1, B, and A2), from baseline (Week 0) through Week 18, with assessments at Weeks 0, 3, 6, 9, 12, 15, and 18 and during all training sessions in phase B
Monitoring adverse events
16 secondary outcomes
Functional capacity
Time frame: During the three consecutive phases of the study (A1, B, and A2), from baseline (Week 0) through Week 18, with assessments at Weeks 0, 3, 6, 9, 12, 15, and 18 (7 assessments in total)
Pulmonary function
Time frame: During the three consecutive phases of the study (A1, B, and A2), from baseline (Week 0) through Week 18, with assessments at Weeks 0, 3, 6, 9, 12, 15, and 18 (7 assessments in total)
Gait ability
Time frame: During the three consecutive phases of the study (A1, B, and A2), from baseline (Week 0) through Week 18, with assessments at Weeks 0, 3, 6, 9, 12, 15, and 18 (7 assessments in total)l
Static and dynamic balance
Time frame: During the three consecutive phases of the study (A1, B, and A2), from baseline (Week 0) through Week 18, with assessments at Weeks 0, 3, 6, 9, 12, 15, and 18 (7 assessments in total)
Speed of movement of the center of pressure per second
Time frame: During the three consecutive phases of the study (A1, B, and A2), from baseline (Week 0) through Week 18, with assessments at Weeks 0, 3, 6, 9, 12, 15, and 18 (7 assessments in total)
Lower limb muscle strength
Time frame: During the three consecutive phases of the study (A1, B, and A2), from baseline (Week 0) through Week 18, with assessments at Weeks 0, 3, 6, 9, 12, 15, and 18 (7 assessments in total)
Spasticity of knee flexor and extensor muscles
Time frame: During the three consecutive phases of the study (A1, B, and A2), from baseline (Week 0) through Week 18, with assessments at Weeks 0, 3, 6, 9, 12, 15, and 18 (7 assessments in total)
Patient quality of life
Time frame: During the three consecutive phases (A1, B, and A2), with assessments at baseline (Week 0), Week 6, Week 12, and Week 18 (4 assessments in total)
General fatigue
Time frame: During the three consecutive phases (A1, B, and A2), with assessments at baseline (Week 0), Weeks 3, 6, 12, and 18 (5 assessments in total).
Patient pain
Time frame: During the three consecutive phases (A1, B, and A2), with assessments at baseline (Week 0), Week 6, Week 12, and Week 18 (4 assessments in total).
Anxiety and depression
Time frame: During the three consecutive phases (A1, B, and A2), with assessments at baseline (Week 0), Week 6, Week 12, and Week 18 (4 assessments in total).
Intrinsic motivation
Time frame: week 12
Subjective impact of gait training with Atalante exoskeleton on participants
Time frame: week 12
Participants' attitudes to Atalante gait training
Time frame: week 12
Efficacy and interactivity of the Atalante exoskeleton
Time frame: Week 12
Participants' experience of gait training with Atalante exoskeleton
Time frame: week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Results publication: PubMed 26152368Labra J, Menon P, Byth K, Morrison S, Vucic S. Rate of disease progression: a prognostic biomarker in ALS. J Neurol Neurosurg Psychiatry. 2016 Jun;87(6):628-32. doi: 10.1136/jnnp-2015-310998. Epub 2015 Jul 7.
- Results publication: PubMed 16434671Kimura F, Fujimura C, Ishida S, Nakajima H, Furutama D, Uehara H, Shinoda K, Sugino M, Hanafusa T. Progression rate of ALSFRS-R at time of diagnosis predicts survival time in ALS. Neurology. 2006 Jan 24;66(2):265-7. doi: 10.1212/01.wnl.0000194316.91908.8a.
- Results publication: PubMed 32896088Abidi M, de Marco G, Grami F, Termoz N, Couillandre A, Querin G, Bede P, Pradat PF. Neural Correlates of Motor Imagery of Gait in Amyotrophic Lateral Sclerosis. J Magn Reson Imaging. 2021 Jan;53(1):223-233. doi: 10.1002/jmri.27335. Epub 2020 Sep 7.
- Derived from this study: PubMed 42387593Trad G, Lenglet T, Ledoux I, Querin G, Blancho S, Marchand-Pauvert V, Hogrel JY, Pradat PF. Safety, feasibility and preliminary effects of Atalante exoskeleton-assisted gait training in amyotrophic lateral sclerosis: a prospective ABA pilot study. J Neuroeng Rehabil. 2026 Jul 1. doi: 10.1186/s12984-026-02046-y. Online ahead of print.
- Derived from this study: PubMed 42026110Trad G, Lenglet T, Ledoux I, Querin G, Blancho S, Marchand-Pauvert V, Pradat PF, Hogrel JY. Exploring the interplay between quantitative muscle strength, functional performance, and patient-reported outcomes in amyotrophic lateral sclerosis: a cross-sectional pilot study. Sci Rep. 2026 Apr 24;16(1):18813. doi: 10.1038/s41598-026-45898-z.
- Derived from this study: PubMed 41545051Trad G, Lenglet T, Ledoux I, Querin G, Blancho S, Marchand-Pauvert V, Hogrel JY, Pradat PF. Safety and efficacy of the Atalante exoskeleton in the rehabilitation of French patients with amyotrophic lateral sclerosis: a prospective, monocentric, open, uncontrolled, interventional protocol, EXALS. BMJ Open. 2026 Jan 16;16(1):e109620. doi: 10.1136/bmjopen-2025-109620.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after de-identification, may be made available upon reasonable request from the corresponding author. Data sharing will be subject to institutional and ethical approvals.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ghida TRAD, PhD study chair
Sorbonne Université, Inserm, CNRS, Laboratoire d'Imagerie Biomédicale (LIB), 75006-Paris (France), Neuromuscular Physiology and Evaluation Lab, Neuromuscular Investigation Center, Institute of Myology, 75013-Paris (France)
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atalante exoskeleton in people with ALS - Amyotrophic Lateral Sclerosis, run by Institut de Recherche sur la Moelle épinière et l'Encéphale at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of Atalante exoskeleton (time frame: During the three consecutive phases of the study (A1, B, and A2), from baseline (Week 0) through Week 18, with assessments at Weeks 0, 3, 6, 9, 12, 15, and 18 and during all training sessions in phase B). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06199284, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.