Assessment of the Interest of the Atalante Device for Patients With Manual Wheelchairs

NCT ID: NCT05909774

Last Updated: 2023-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-09
• Study Completion Date: 2017-09-08

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

Conditions

Complete Motor Paraplegia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Exoskeleton second

This group first perform tests without Atalante exoskeleton and secondly with Atalante exoskeleton. A second randomization is performed inside each group, with half of the patients first performing walk test with the "Continuous" walk and then with the "Push \& Swing" walk, and the other half doing the opposite.

Group Type: EXPERIMENTAL

Test with Atalante exoskeleton in "continuous walk" type

Intervention Type: DEVICE

The "continuous" walk is smoother and more physiologic than the "push and swing" walk

Exoskeleton first

This group first perform tests with Atalante exoskeleton and secondly without Atalante exoskeleton. A second randomization is performed inside each group, with half of the patients first performing walk test with the "Continuous" walk and then with the "Push \& Swing" walk, and the other half doing the opposite.

Group Type: ACTIVE_COMPARATOR

Test with Atalante exoskeleton in "continuous walk" type

Intervention Type: DEVICE

The "continuous" walk is smoother and more physiologic than the "push and swing" walk

Interventions

Test with Atalante exoskeleton in "continuous walk" type

The "continuous" walk is smoother and more physiologic than the "push and swing" walk

Intervention Type: DEVICE

Other Intervention Names

Test with Atalante exoskeleton in "push and swing" walk type

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wandercraft

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thierry Albert, MD

Role: PRINCIPAL_INVESTIGATOR

COS CMPR de Bobigny

Locations

CEREMH (Centre de ressources et d'innovation mobilité handicap)

Vélizy-Villacoublay, , France

Countries

France

Other Identifiers

2016-A01257-44

Identifier Type: -

Identifier Source: org_study_id