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

Primary Purpose

Complete Motor Paraplegia

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Test with Atalante exoskeleton in "continuous walk" type
Sponsored by
Wandercraft
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Complete Motor Paraplegia focused on measuring exoskeleton, paraplegia, rehabilitation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Exoskeleton second

Exoskeleton first

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Assessment of the superiority of the Atalante exoskeleton compared to the usual aid
Evaluation of walking ability through a 10mWT
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)
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)
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)
Assessment of the static and dynamic postural stability
Static balance test with measurement of center of pressure displacement
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
Assessment of the perceived effort by the patient
Evaluation of perceived effort by the patient through a Borg CR-10 scale
Assessment of perceived safety by the patient
Evaluation of perceived safety by the patient through a 7-point Likert scale
Assessment of the overall satisfaction of patients after using the exoskeleton
Assessment of the patient overall satisfaction through a 7-point Likert scale
Comparison of the two types of walk
Comparison of the two types of walk on walking ability through the 10mWT
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
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

Full Information

First Posted
May 24, 2023
Last Updated
June 8, 2023
Sponsor
Wandercraft
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1. Study Identification

Unique Protocol Identification Number
NCT05909774
Brief Title
Assessment of the Interest of the Atalante Device for Patients With Manual Wheelchairs
Acronym
M1-M2
Official Title
Assessment of the Interest of the Atalante Device for Patients With Manual Wheelchairs
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
December 9, 2016 (Actual)
Primary Completion Date
September 8, 2017 (Actual)
Study Completion Date
September 8, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wandercraft

4. Oversight

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

5. Study Description

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: 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 Assessment of the static and dynamic postural stability of the subject with the Atalante exoskeleton by observation of center of pressure displacement and velocity Assessment of the perceived effort by the patient Assessment of perceived safety by the patient Assessment of the overall satisfaction of patients after using the exoskeleton Comparison of the two types of walk on walking ability, perceived effort, and safety

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complete Motor Paraplegia
Keywords
exoskeleton, paraplegia, rehabilitation

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Prospective, multicentric, comparative, randomized cross-over study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exoskeleton second
Arm Type
Experimental
Arm Description
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.
Arm Title
Exoskeleton first
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Test with Atalante exoskeleton in "continuous walk" type
Other Intervention Name(s)
Test with Atalante exoskeleton in "push and swing" walk type
Intervention Description
The "continuous" walk is smoother and more physiologic than the "push and swing" walk
Primary Outcome Measure Information:
Title
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).
Description
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.
Time Frame
Day 2
Secondary Outcome Measure Information:
Title
Assessment of the superiority of the Atalante exoskeleton compared to the usual aid
Description
Evaluation of walking ability through a 10mWT
Time Frame
Day 2
Title
Assessment of the superiority of the Atalante exoskeleton compared to the usual aid
Description
Evaluation of verticalization ability through a success/failure test in a verticalization test (sit-to-stand movement)
Time Frame
Day 2
Title
Assessment of the superiority of the Atalante exoskeleton compared to the usual aid
Description
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)
Time Frame
Day 2
Title
Assessment of the superiority of the Atalante exoskeleton compared to the usual aid
Description
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)
Time Frame
Day 2
Title
Assessment of the static and dynamic postural stability
Description
Static balance test with measurement of center of pressure displacement
Time Frame
Day 2
Title
Assessment of the static and dynamic postural stability
Description
Dynamic balance test with measurement of the average surface area under the (Center of Pressure position, Center of Pressure velocity) curve
Time Frame
Day 2
Title
Assessment of the perceived effort by the patient
Description
Evaluation of perceived effort by the patient through a Borg CR-10 scale
Time Frame
Day 2
Title
Assessment of perceived safety by the patient
Description
Evaluation of perceived safety by the patient through a 7-point Likert scale
Time Frame
Day 2
Title
Assessment of the overall satisfaction of patients after using the exoskeleton
Description
Assessment of the patient overall satisfaction through a 7-point Likert scale
Time Frame
Day 2
Title
Comparison of the two types of walk
Description
Comparison of the two types of walk on walking ability through the 10mWT
Time Frame
Day 2
Title
Comparison of the two types of walk
Description
Comparison of the two types of walk on perceived effort during the 10mWT through a Borg CR-10 Scale
Time Frame
Day 2
Title
Comparison of the two types of walk
Description
Comparison of the two types of walk on perceived safety during the 10mWT through a 7-point Likert scale
Time Frame
Day 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thierry Albert, MD
Organizational Affiliation
COS CMPR de Bobigny
Official's Role
Principal Investigator
Facility Information:
Facility Name
CEREMH (Centre de ressources et d'innovation mobilité handicap)
City
Vélizy-Villacoublay
ZIP/Postal Code
78140
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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