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

Institut de Recherche sur la Moelle épinière et l'Encéphale

Status

Enrolling

Conditions

ALS - Amyotrophic Lateral Sclerosis

Treatments

Device: Atalante exoskeleton

Study type

Interventional

Funder types

Other

Identifiers

NCT06199284

2023-A00553-42

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with amyotrophic lateral sclerosis (defined according to the El Escorial criteria: possible, probable or definite), at the time of diagnosis
Slowly and intermediate evolving patients ∆ Progression rate (PR) ≤ 1.11
Manual muscle testing ≥ 4 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"
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
Fronto-temporal dementia associated with ALS
Pregnancy or attempted pregnancy