ALS - Amyotrophic Lateral Sclerosis
Conditions
Keywords
Atalante exoskeleton, Gait training, Amyotrophic lateral sclerosis, Rehabilitation, Robotics
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.
Interventions
DEVICEAtalante exoskeleton
The gait training program using Atalante exoskeleton consisted of 3 sessions per week for 6 weeks. Each session includes the patient's installation and de-installation (10 min), walking training (30 min), and physical activities at the end of the session where the patient is in an upright position in the exoskeleton (e.g. badminton, boxing, or basketball) (5-10 min). For each participant, the assistance of the exoskeleton can be specifically adjusted and can be set symmetrically or asymmetrically bases on his capabilities.
Sponsors
Association pour la Recherche sur la Sclérose Latérale Amyotrophique et autres Maladies du Motoneurone
Groupe Hospitalier Pitie-Salpetriere
Institut de Myologie, France
Station Debout
Laboratory of Biomedical Imaging
Institut de Recherche sur la Moelle épinière et l'Encéphale
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
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
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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°.
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 * Pregnancy or attempted pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of Atalante exoskeleton | During the three consecutive phases of the study (A1, B, and A2), from baseline (Week 0) through Week 18, with assessments at Weeks 0, 3, 6, 9, 12, 15, and 18 and during all training sessions in phase B | Monitoring adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pulmonary function | During the three consecutive phases of the study (A1, B, and A2), from baseline (Week 0) through Week 18, with assessments at Weeks 0, 3, 6, 9, 12, 15, and 18 (7 assessments in total) | Forced vital capacity |
| Gait ability | During the three consecutive phases of the study (A1, B, and A2), from baseline (Week 0) through Week 18, with assessments at Weeks 0, 3, 6, 9, 12, 15, and 18 (7 assessments in total)l | The 6-minute walk test, the 10-meter walk test and the Timed Up and Go test |
| Static and dynamic balance | During the three consecutive phases of the study (A1, B, and A2), from baseline (Week 0) through Week 18, with assessments at Weeks 0, 3, 6, 9, 12, 15, and 18 (7 assessments in total) | Berg Balance Scale (0 - 56) with higher scores representing better balance |
| Speed of movement of the center of pressure per second | During the three consecutive phases of the study (A1, B, and A2), from baseline (Week 0) through Week 18, with assessments at Weeks 0, 3, 6, 9, 12, 15, and 18 (7 assessments in total) | Force platform |
| Lower limb muscle strength | During the three consecutive phases of the study (A1, B, and A2), from baseline (Week 0) through Week 18, with assessments at Weeks 0, 3, 6, 9, 12, 15, and 18 (7 assessments in total) | Isometric dynamometer |
| Spasticity of knee flexor and extensor muscles | During the three consecutive phases of the study (A1, B, and A2), from baseline (Week 0) through Week 18, with assessments at Weeks 0, 3, 6, 9, 12, 15, and 18 (7 assessments in total) | Instrumental assessment with isokinetic dynamometer |
| Patient quality of life | During the three consecutive phases (A1, B, and A2), with assessments at baseline (Week 0), Week 6, Week 12, and Week 18 (4 assessments in total) | ALSAQ-40 |
| Functional capacity | During the three consecutive phases of the study (A1, B, and A2), from baseline (Week 0) through Week 18, with assessments at Weeks 0, 3, 6, 9, 12, 15, and 18 (7 assessments in total) | ALSFRS-R |
| Patient pain | During the three consecutive phases (A1, B, and A2), with assessments at baseline (Week 0), Week 6, Week 12, and Week 18 (4 assessments in total). | Brief pain inventory-short form |
| Anxiety and depression | During the three consecutive phases (A1, B, and A2), with assessments at baseline (Week 0), Week 6, Week 12, and Week 18 (4 assessments in total). | Hospital anxiety and depression scale |
| Intrinsic motivation | week 12 | Intrinsic motivation inventory |
| Subjective impact of gait training with Atalante exoskeleton on participants | week 12 | The participant's experience with domain-oriented exoskeleton training |
| Participants' attitudes to Atalante gait training | week 12 | Net promoter score |
| Efficacy and interactivity of the Atalante exoskeleton | Week 12 | A specific questionnaire was developed to assess the efficacy and interactivity of the Atalante exoskeleton |
| Participants' experience of gait training with Atalante exoskeleton | week 12 | Semi-structured interview |
| General fatigue | During the three consecutive phases (A1, B, and A2), with assessments at baseline (Week 0), Weeks 3, 6, 12, and 18 (5 assessments in total). | Fatigue Severity Scale and the Modified Fatigue Impact Scale |
Countries
France
Outcome results
None listed