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

Evaluation of the Safety and Efficacy of the Atalante Exoskeleton in the Rehabilitation of Patients With Amyotrophic Lateral Sclerosis

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: Recruiting
• 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 Contact: Name: Pierre-François PRADAT, MD, PhD; Phone Number: 01 42 17 62 05; Email: pierre-francois.pradat@aphp.fr
• Study Contact Backup: Name: Ghida TRAD, PhD; Email: ghida.trad@inserm.fr

Study Locations

• France
  • Paris, France, 75001
    • Recruiting
    • Station Debout
    • Contact: Sophie BLANCHO, Directrice; Email: irme@orange.fr
    • Contact: Ghida TRAD, PhD; Email: ghida.trad@station-debout.fr

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
• Slowly evolving patients: ∆ Progression rate (PR) ≤ 0.5
• Manual muscle testing ≥ 3 for deltoid muscle et ≥ 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"
• Normal ability to writing and prepare food: score = 8 on all 2 ALSFRS-R sub-items "handwriting" and "cutting food and handling utensils"
• 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
• 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
• Fronto-temporal dementia associated with ALS
• 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; Usual care and gait training with the Atalante exoskeleton	Device: Atalante exoskeleton; The gait training program using Atalante exoskeleton consisted of 3 sessions per week for 6 weeks. 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	Week 7 to week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional capacity	ALSFRS-R	An assessment every three weeks, seven assessments in total
Pulmonary function	Forced vital capacity	An assessment every three weeks, seven assessments in total
Gait ability	The 6-minute walk test, the 10-meter walk test and the Timed up and go test	An assessment every three weeks, seven assessments in total
Balance	Berg balance scale	An assessment every three weeks, seven assessments in total
Postural stability	Force platform	An assessment every three weeks, seven assessments in total
Lower limb muscle strength	Isometric dynamometer	An assessment every three weeks, seven assessments in total
Spasticity	Instrumental assessment with isometric dynamometer	An assessment every three weeks, seven assessments in total
Patient quality of life	ALSAQ-40	An assessment every six weeks, four assessments in total
Patient pain	Brief pain inventory-short form	An assessment every six weeks, four assessments in total
Anxiety and depression	Hospital anxiety and depression scale	An assessment every six weeks, four assessments in total
Fatigue	Fatigue severity scale	An assessment every six weeks, four assessments in total
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
Participants' qualitative experience of gait training with Atalante exoskeleton	Three words describing the patient's experience	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: Principal Investigator: Timothée LENGLET, MD, PhD, Centre de Référence SLA Ile de France, APHP, Hôpital Pitié-Salpêtrière, Paris (France)

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): December 1, 2026

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 (Actual): January 10, 2024
• Last Update Submitted That Met QC Criteria: December 29, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

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

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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