Atalante Exoskeleton in the Rehabilitation of Patients With Amyotrophic Lateral Sclerosis (EXALS)

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.

Study Overview

• Status: Suspended
• Conditions: ALS - Amyotrophic Lateral Sclerosis
• Intervention / Treatment: Device: Atalante exoskeleton

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 Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75013
    • Hôpital Pitié-Salpêtrière
  • Paris, France, 75013
    • Institut de Myologie
  • Paris, France, 75001
    • Station Debout

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Patient; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intrinsic motivation	Intrinsic motivation inventory	week 12
Subjective impact of gait training with Atalante exoskeleton on participants	The participant's experience with domain-oriented exoskeleton training	week 12
Participants' attitudes to Atalante gait training	Net promoter score	week 12
Functional capacity	ALSFRS-R	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	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	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	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	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	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	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	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	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	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	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).
Efficacy and interactivity of the Atalante exoskeleton	A specific questionnaire was developed to assess the efficacy and interactivity of the Atalante exoskeleton	Week 12
Participants' experience of gait training with Atalante exoskeleton	Semi-structured interview	week 12

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): January 29, 2027

Study Registration Dates

• First Submitted: December 29, 2023
• First Submitted That Met QC Criteria: December 29, 2023
• First Posted (Actual): January 10, 2024

Study Record Updates

• Last Update Posted (Estimated): January 12, 2026
• Last Update Submitted That Met QC Criteria: January 8, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Rehabilitation; Robotics; Amyotrophic lateral sclerosis; Gait training; Atalante exoskeleton
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neuromuscular Diseases; Metabolic Diseases; Neurodegenerative Diseases; Spinal Cord Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Motor Neuron Disease; Nutritional and Metabolic Diseases; Amyotrophic Lateral Sclerosis
• Other Study ID Numbers: 2023-A00553-42

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Following publication of the study results
• IPD Sharing 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No