Clinical trial NCT06199284: Atalante Exoskeleton in the Rehabilitation of Patients With Amyotrophic Lateral Sclerosis
Official title: Evaluation of the Safety and Efficacy of the Atalante Exoskeleton in the Rehabilitation of Patients With Amyotrophic Lateral Sclerosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ALS - Amyotrophic Lateral Sclerosis
Keywords: Atalante exoskeleton
Gait training
Amyotrophic lateral sclerosis
Lead sponsor: Institut de Recherche sur la Moelle épinière et l'Encéphale
Sponsor class: OTHER
Collaborators: name: Association pour la Recherche sur la Sclérose Latérale Amyotrophique et autres Maladies du Motoneurone
name: Groupe Hospitalier Pitie-Salpetriere
name: Institut de Myologie, France
name: Station Debout
name: Laboratory of Biomedical Imaging
First posted: 2024-01-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study will be conducted in 3 phases, each lasting 6 weeks, following the ABA procedure. Phase B represents the intervention phase, during which patients will practice their gait training at a rhythm of 3 sessions/week, as an add-on to usual care. In the two phases A, patients receive usual care with no additional treatment
Primary purpose: OTHER

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 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.

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 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.

Eligibility 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

Primary outcomes:
measure: Safety of Atalante exoskeleton
timeFrame: Week 7 to week 12
Secondary outcomes:
measure: Functional capacity
timeFrame: An assessment every three weeks, seven assessments in total
measure: Pulmonary function
timeFrame: An assessment every three weeks, seven assessments in total
measure: Gait ability
timeFrame: An assessment every three weeks, seven assessments in total
measure: Static and dynamic balance
timeFrame: An assessment every three weeks, seven assessments in total
measure: Speed of movement of the center of pressure per second
timeFrame: An assessment every three weeks, seven assessments in total
measure: Lower limb muscle strength
timeFrame: An assessment every three weeks, seven assessments in total
measure: Spasticity
timeFrame: An assessment every three weeks, seven assessments in total
measure: Patient quality of life
timeFrame: An assessment every six weeks, four assessments in total
measure: Patient pain
timeFrame: An assessment every six weeks, four assessments in total
measure: Anxiety and depression
timeFrame: An assessment every six weeks, four assessments in total
measure: Fatigue
timeFrame: An assessment every six weeks, four assessments in total
measure: Intrinsic motivation
timeFrame: week 12
measure: Subjective impact of gait training with Atalante exoskeleton on participants
timeFrame: week 12
measure: Participants' attitudes to Atalante gait training
timeFrame: week 12
measure: Participants' qualitative experience of gait training with Atalante exoskeleton
timeFrame: week 12
measure: Fatigue's impact on physical, cognitive and psychosocial functions
timeFrame: An assessment every 3 weeks in the first phase of the study, then an assessment every 6 weeks in the subsequent phases, five assessments in total
measure: Effectiveness of the exoskeleton and its interactivity
timeFrame: Week 12
measure: Cardiovascular parameters
timeFrame: Before and after each exoskeleton assisted gait training session
measure: Instantaneous pain
timeFrame: Before and after each exoskeleton assisted gait training session
measure: Instantaneous fatigue
timeFrame: Before and after each exoskeleton assisted gait training session
Other outcomes:
Locations:
city: Paris
country: France
facility: Station Debout
Study officials:
affiliation: Centre de Référence SLA Ile de France, APHP, Hôpital Pitié-Salpêtrière, Paris (France)
name: Timothée LENGLET, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abidi M, de Marco G, Grami F, Termoz N, Couillandre A, Querin G, Bede P, Pradat PF. Neural Correlates of Motor Imagery of Gait in Amyotrophic Lateral Sclerosis. J Magn Reson Imaging. 2021 Jan;53(1):223-233. doi: 10.1002/jmri.27335. Epub 2020 Sep 7.