Assessment of the Interest of the Atalante Device for Patients With Manual Wheelchairs (M1-M2)

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.

Study Overview

• Status: Completed
• Conditions: Complete Motor Paraplegia
• Intervention / Treatment: Device: Test with Atalante exoskeleton in "continuous walk" type

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

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Vélizy-Villacoublay, France, 78140
    • CEREMH (Centre de ressources et d'innovation mobilité handicap)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Test with Atalante exoskeleton in "continuous walk" type; The "continuous" walk is smoother and more physiologic than the "push and swing" walk; Other Names: Test with Atalante exoskeleton in "push and swing" walk type
Active Comparator: 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.	Device: Test with Atalante exoskeleton in "continuous walk" type; The "continuous" walk is smoother and more physiologic than the "push and swing" walk; Other Names: Test with Atalante exoskeleton in "push and swing" walk type

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the superiority of the Atalante exoskeleton compared to the usual aid	Evaluation of walking ability through a 10mWT	Day 2
Assessment of the superiority of the Atalante exoskeleton compared to the usual aid	Evaluation of verticalization ability through a success/failure test in a verticalization test (sit-to-stand movement)	Day 2
Assessment of the superiority of the Atalante exoskeleton compared to the usual aid	Evaluation of static balance through a success failure in a static standing test without support from the operator (3 x 30s in a static standing position)	Day 2
Assessment of the superiority of the Atalante exoskeleton compared to the usual aid	Evaluation of dynamic balance through a success/failure in a pointing test performed in a standing position without support from the operator (3 pointing sequences)	Day 2
Assessment of the static and dynamic postural stability	Static balance test with measurement of center of pressure displacement	Day 2
Assessment of the static and dynamic postural stability	Dynamic balance test with measurement of the average surface area under the (Center of Pressure position, Center of Pressure velocity) curve	Day 2
Assessment of the perceived effort by the patient	Evaluation of perceived effort by the patient through a Borg CR-10 scale	Day 2
Assessment of perceived safety by the patient	Evaluation of perceived safety by the patient through a 7-point Likert scale	Day 2
Assessment of the overall satisfaction of patients after using the exoskeleton	Assessment of the patient overall satisfaction through a 7-point Likert scale	Day 2
Comparison of the two types of walk	Comparison of the two types of walk on walking ability through the 10mWT	Day 2
Comparison of the two types of walk	Comparison of the two types of walk on perceived effort during the 10mWT through a Borg CR-10 Scale	Day 2
Comparison of the two types of walk	Comparison of the two types of walk on perceived safety during the 10mWT through a 7-point Likert scale	Day 2

Collaborators and Investigators

• Sponsor: Wandercraft
• Investigators: Principal Investigator: Thierry Albert, MD, COS CMPR de Bobigny

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2016
• Primary Completion (Actual): September 8, 2017
• Study Completion (Actual): September 8, 2017

Study Registration Dates

• First Submitted: May 24, 2023
• First Submitted That Met QC Criteria: June 8, 2023
• First Posted (Estimated): June 19, 2023

Study Record Updates

• Last Update Posted (Estimated): June 19, 2023
• Last Update Submitted That Met QC Criteria: June 8, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: rehabilitation; exoskeleton; paraplegia
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Paralysis; Paraplegia
• Other Study ID Numbers: 2016-A01257-44

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No