Using the Atalante exoskeleton for rehabilitation in ALS patients
Evaluation of the Safety and Efficacy of the Atalante Exoskeleton in the Rehabilitation of Patients With Amyotrophic Lateral Sclerosis
This study is testing if using the Atalante exoskeleton can help people with ALS improve their walking ability and overall experience compared to regular treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Institut de Recherche sur la Moelle épinière et l'Encéphale Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT06199284 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of the Atalante exoskeleton as a gait training tool for patients with amyotrophic lateral sclerosis (ALS). It aims to understand how ALS affects central neural networks involved in gait and whether the exoskeleton can enhance compensatory network reorganization through proprioceptive input. Participants will undergo gait training with the exoskeleton, and their walking ability, functional capacity, and overall experience will be compared to usual care. The study emphasizes participant involvement and motivation, making it a significant contribution to the field of robotic rehabilitation in ALS.
Who should consider this trial
Good fit: Ideal candidates are French-speaking ALS patients with stable gait deficits and specific muscle strength criteria.
Not a fit: Patients with rapidly progressing ALS or those who do not meet the specific inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve walking ability and overall quality of life for ALS patients.
How similar studies have performed: While there are limited studies on gait rehabilitation exoskeletons in ALS, this study represents a novel approach with rigorous design.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Paris
- Station Debout — Paris, France (Recruiting)
Study contacts
- Principal investigator: Timothée LENGLET, MD, PhD — Centre de Référence SLA Ile de France, APHP, Hôpital Pitié-Salpêtrière, Paris (France)
- Study coordinator: Pierre-François PRADAT, MD, PhD
- Email: pierre-francois.pradat@aphp.fr
- Phone: 01 42 17 62 05
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.