Atalante Exoskeleton in the Rehabilitation of Patients With Amyotrophic Lateral Sclerosis

NCT06199284 | Suspended DMC

• 1 other identifier: 2023-A00553-42
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

Brief 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. 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.

Conditions

ALS - Amyotrophic Lateral Sclerosis

Keywords

Atalante exoskeleton; Gait training; Amyotrophic lateral sclerosis; Rehabilitation; Robotics

Outcome Measures

Primary Outcomes (1)

• Safety of Atalante exoskeleton

  Monitoring adverse events

  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

  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

  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

  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

  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

  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)

Study Arms (1)

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.

Device: Atalante exoskeleton

Interventions

Atalante exoskeleton DEVICE

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.

Patient

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• cm if ankle dorsi flexion is ≥16°

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut de Recherche sur la Moelle épinière et l'Encéphale: lead
• Association pour la Recherche sur la Sclérose Latérale Amyotrophique et autres Maladies du Motoneurone: collaborator
• Groupe Hospitalier Pitie-Salpetriere: collaborator
• Institut de Myologie, France: collaborator
• Station Debout: collaborator
• Laboratory of Biomedical Imaging: collaborator

Study Sites (3)

Station Debout

Paris, 75001, France

Location

Hôpital Pitié-Salpêtrière

Paris, 75013, France

Location

Institut de myologie

Paris, 75013, France

Location

Related Publications (4)

• 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.

  PMID: 26152368 RESULT

• Kimura 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.

  PMID: 16434671 RESULT

• Abidi 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.

  PMID: 32896088 RESULT

• Trad 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.

  PMID: 41545051 DERIVED

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

Study Officials

• Ghida TRAD, PhD

  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)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: December 29, 2023
• First Posted: January 10, 2024
• Study Start: January 31, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): January 29, 2027
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Following publication of the study results
• Access Criteria: Researchers with a methodologically sound proposal and appropriate ethical approval may request access to the de-identified data and supporting documents from the corresponding author

Locations

FR (3)