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

NCT05909774 | Completed

• 1 other identifier: 2016-A01257-44
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Complete Motor Paraplegia

Keywords

exoskeleton; paraplegia; rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Assessment of the superiority of the Atalante exoskeleton compared to the usual aid

  Day 2

• Assessment of the superiority of the Atalante exoskeleton compared to the usual aid

  Day 2

• Assessment of the superiority of the Atalante exoskeleton compared to the usual aid

  Day 2

• Assessment of the superiority of the Atalante exoskeleton compared to the usual aid

  Day 2

• Assessment of the static and dynamic postural stability

  Day 2

Study Arms (2)

Exoskeleton second

EXPERIMENTAL

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

Exoskeleton first

ACTIVE COMPARATOR

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

Interventions

Test with Atalante exoskeleton in "continuous walk" type DEVICE

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

Also known as: Test with Atalante exoskeleton in "push and swing" walk type

Exoskeleton first; Exoskeleton second

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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°

You may not qualify if:

• 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

Sponsors & Collaborators

• Wandercraft: lead

Study Sites (1)

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

Vélizy-Villacoublay, 78140, France

Location

MeSH Terms

Conditions

Paraplegia

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Thierry Albert, MD

  COS CMPR de Bobigny

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, multicentric, comparative, randomized cross-over study

Study Record Dates

• First Submitted: May 24, 2023
• First Posted: June 18, 2023
• Study Start: December 9, 2016
• Primary Completion: September 8, 2017
• Study Completion: September 8, 2017
• Last Updated: June 18, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)