NCT06199284Felfüggesztve
Atalante Exoskeleton in the Rehabilitation of Patients With Amyotrophic Lateral Sclerosis
Safety and Efficacy of the Atalante Exoskeleton in the Rehabilitation of Patients With Amyotrophic Lateral Sclerosis: Study Protocol for an Open, Uncontrolled Interventional Study, EXALS.
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. jan. 12.
Megadott ok: Recruitment is suspended due to funding issues
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Felfüggesztve
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 20 (tervezett)
- Első benyújtás
- 2023. dec. 29.
- Kezdés
- 2024. jan. 31.
- Elsődleges befejezés
- 2026. szept. 30.
- Fő szponzor
- Institut de Recherche sur la Moelle épinière et l'Encéphale
- Betegségek
- Amiotrófiás laterálszklerózis (ALS)
- NCT-szám
- NCT06199284
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Más betegség
- Cardiac or respiratory contraindications to physical effort
- Cognitive impairment that can affect comprehension
Egyéb
- 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
- Pregnancy or attempted pregnancy
Kiket keres a vizsgálat
- 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:
- 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°.
Életkor a regiszterben: 18 év – 70 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (3)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Station Debout | Paris | Franciaország | Ismeretlen állapot |
| Institut de Myologie | Paris | Franciaország | Ismeretlen állapot |
| Hopital Pitie-Salpetriere | Paris | Franciaország | Ismeretlen állapot |
Kapcsolódó publikációk
- Safety, feasibility and preliminary effects of Atalante exoskeleton-assisted gait training in amyotrophic lateral sclerosis: a prospective ABA pilot study.J Neuroeng Rehabil · 2026 · PMID 42387593
- Exploring the interplay between quantitative muscle strength, functional performance, and patient-reported outcomes in amyotrophic lateral sclerosis: a cross-sectional pilot study.Sci Rep · 2026 · PMID 42026110
- Safety and efficacy of the Atalante exoskeleton in the rehabilitation of French patients with amyotrophic lateral sclerosis: a prospective, monocentric, open, uncontrolled, interventional protocol, EXALS.BMJ Open · 2026 · PMID 41545051
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