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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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°

• 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°.

Locations
Other Locations
France
Station Debout
RECRUITING
Paris
Contact Information
Primary
Pierre-François PRADAT, MD, PhD
pierre-francois.pradat@aphp.fr
01 42 17 62 05
Backup
Ghida TRAD, PhD
ghida.trad@inserm.fr
Time Frame
Start Date: 2024-01-31
Estimated Completion Date: 2027-01
Participants
Target number of participants: 20
Treatments
Other: Patient
Usual care and gait training with the Atalante exoskeleton
Sponsors
Collaborators: Institut de Myologie, France, Station Debout, Laboratory of Biomedical Imaging, Association pour la Recherche sur la Sclérose Latérale Amyotrophique et autres Maladies du Motoneurone, Groupe Hospitalier Pitie-Salpetriere
Leads: Institut de Recherche sur la Moelle épinière et l'Encéphale

This content was sourced from clinicaltrials.gov