Clinical trial NCT05909774: Assessment of the Interest of the Atalante Device for Patients With Manual Wheelchairs
Official title: Assessment of the Interest of the Atalante Device for Patients With Manual Wheelchairs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Complete Motor Paraplegia
Keywords: exoskeleton
paraplegia
rehabilitation
Lead sponsor: Wandercraft
Sponsor class: INDUSTRY
First posted: 2023-06-18
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Prospective, multicentric, comparative, randomized cross-over study
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The loss of standing and walking capabilities in a paraplegic person is most often the result of damage to the spinal cord, either traumatic (accidental) or pathological and has both a somatic and a psychological impact on the quality of life, the risk of depression, and the difficulty of socio-professional reintegration in a society that is not adapted to people with disabilities.

A motorized mechanical exoskeleton is an external device intended to compensate for a muscular or neurological deficiency enabling paraplegics to stand and walk again. The Atalante exoskeleton, designed by Wandercraft company allows patients to stand upright and walk without the aid of crutches.

This early study was the first clinical investigation of the Atalante exoskeleton performed early in the development. It was used to evaluate the device design concept with respect to initial clinical safety and device functionality and guided further device modifications.

Detailed description: The aim of this study was to test the use of the Atalante exoskeleton on 10 patients with complete motor paraplegia (ASIA A and B) with a level of injury between T6 and S1.

In this multi-centric clinical trial, patients were asked to perform between 1 and 2 days of training with Atalante exoskeleton including device training and evaluations (up to 9 hours of training and 3 hours of evaluation per patient).

The primary objective of this study was to assess patients' ability to walk straight- for 10 meters with the Atalante exoskeleton during 10-meters walk test (10MWT).

Within-group differences between the Atalante exoskeleton and the usual walking aid used by the patient in the success rate of the 10MWT were compared by a McNemar test.

The secondary objectives focused on performance evaluation with the Atalante exoskeleton. The assessments performed were:

1. Assessment of the superiority of the Atalante exoskeleton compared to the usual aid walking assistance used by the patient on the walking, verticalization (or sit-to-stand), static and dynamic balance ability
2. Assessment of the static and dynamic postural stability of the subject with the Atalante exoskeleton by observation of center of pressure displacement and velocity
3. Assessment of the perceived effort by the patient
4. Assessment of perceived safety by the patient
5. Assessment of the overall satisfaction of patients after using the exoskeleton
6. Comparison of the two types of walk on walking ability, perceived effort, and safety

Eligibility criteria: Inclusion Criteria:

* Under 60 years of age
* Daily and autonomous use of wheelchair
* Paraplegia with level of injury between T6 and S1
* Patient unable to walk, neither during physiotherapy session nor in a daily routine
* Patient with cognitive capacities: able to understand oral and/or written instructions, as well as instructions given by demonstration
* Able to use their upper limbs
* Can be verticalized
* Patient with a health care insurance
* Patient having given his/her written consent
* Joints amplitudes compatible with the use of the exoskeleton:
* Hip: Flexion\>115°; Extension\>15°; Abduction\>17°; Adduction \>10°; Medial rotation\>35°; Internal rotation\>10°
* Knee: Flexion\>105°; Extension\> -5°
* Ankle: Flexion\>0°; Extension\>9°; Supination\>18°; Pronation\>18°

Exclusion Criteria:

* Severe or complete deficiency of the upper limbs
* Bad control of the trunk
* Vestibular disorder (loss of balance, dizziness, ...) when placed in the vertical position
* Upper limbs involuntary shivers and/or movements
* Pregnant women
* A lower or upper limb amputated
* Epilepsy
* Patient carrying an active implantable medical device

Primary outcomes:
measure: The primary objective of this study was to assess patients' ability to walk straight- for 10 meters with the Atalante exoskeleton during 10-meters walk test (10MWT).
timeFrame: Day 2
Secondary outcomes:
measure: Assessment of the superiority of the Atalante exoskeleton compared to the usual aid
timeFrame: Day 2
measure: Assessment of the superiority of the Atalante exoskeleton compared to the usual aid
timeFrame: Day 2
measure: Assessment of the superiority of the Atalante exoskeleton compared to the usual aid
timeFrame: Day 2
measure: Assessment of the superiority of the Atalante exoskeleton compared to the usual aid
timeFrame: Day 2
measure: Assessment of the static and dynamic postural stability
timeFrame: Day 2
measure: Assessment of the static and dynamic postural stability
timeFrame: Day 2
measure: Assessment of the perceived effort by the patient
timeFrame: Day 2
measure: Assessment of perceived safety by the patient
timeFrame: Day 2
measure: Assessment of the overall satisfaction of patients after using the exoskeleton
timeFrame: Day 2
measure: Comparison of the two types of walk
timeFrame: Day 2
measure: Comparison of the two types of walk
timeFrame: Day 2
measure: Comparison of the two types of walk
timeFrame: Day 2
Other outcomes:
Locations:
city: Vélizy-Villacoublay
country: France
facility: CEREMH (Centre de ressources et d'innovation mobilité handicap)
Study officials:
affiliation: COS CMPR de Bobigny
name: Thierry Albert, MD
role: PRINCIPAL_INVESTIGATOR
References: