Status:
RECRUITING
Atalante Exoskeleton in the Rehabilitation of Patients With Amyotrophic Lateral Sclerosis
Lead Sponsor:
Institut de Recherche sur la Moelle épinière et l'Encéphale
Collaborating Sponsors:
Association pour la Recherche sur la Sclérose Latérale Amyotrophique et autres Maladies du Motoneurone
Groupe Hospitalier Pitie-Salpetriere
Conditions:
ALS - Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief 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...
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 determin...
Eligibility Criteria
Inclusion
- 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:
- 7cm if ankle dorsi flexion is ≥16°
- 7cm if ankle dorsi flexion is ≥13°and \<16°
- 7cm if ankle dorsi flexion is\>10°and ≤13°
- 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
- 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
Key Trial Info
Start Date :
January 31 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 29 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06199284
Start Date
January 31 2024
End Date
January 29 2027
Last Update
December 15 2025
Active Locations (3)
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1
Station Debout
Paris, France, 75001
2
Hôpital Pitié-Salpêtrière
Paris, France, 75013
3
Institut de myologie
Paris, France, 75013