Back to resultsClinical Investigation of the Quality of Life Benefit of Using a Home Walking Exoskeleton for a Population of Multiple Sclerosis Patients. (EXHOMESEP)
Primary Purpose
Multiple Sclerosis
Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Keeogo
adviced home practice
Sponsored by
About this trial
This is an interventional supportive care trial for Multiple Sclerosis
Eligibility Criteria
Inclusion Criteria: Patient with multiple sclerosis according to the revised Mac Donald diagnostic criteria (2017) in the relapsing-remitting form more than 6 months from a relapsing or progressive period. An Expanded Disability Status Scale (EDSS) between 5 and 6.5 on the EDSS scale (Kurtzke 1983) Living at home Using a walking aid 18 years old or older Have freely consented to participate in this study To be more than 1m52 tall Hip Manual Muscle Testing (MMT) score ≥ 3+ (flexors and expanders) Knee Manual Muscle Testing (MMT) score ≥ 2 (flexors and expanders) Berg scale (BBS) score > 20 Patient affiliated with a social security plan or beneficiary of such a plan. Non-Inclusion Criteria: Impaired comprehension preventing completion of the protocol Inability to walk without assistance for 10 minutes Have a rehabilitation stay scheduled during the follow-up period of the clinical investigation Diagnosed psychiatric conditions that may have an impact on the experience of withdrawal of technical assistance at the end of the protocol Severe cognitive impairment (MMSE<24) Person deprived of liberty by a judicial or administrative decision A person under psychiatric care or admitted to a health or social institution for purposes other than research. Spasticity >3 on the Held and Tardieu scale affecting the hamstring, quadriceps, adductor or sural triceps muscles Complete paralysis of the lower limbs Severe osteoporosis Hip and/or knee replacements that would sufficiently limit range of motion for walking and sitting or squatting Severe vascular disorders of the lower limbs Existing wounds or skin lesions where the device is worn Pregnant woman or postpartum woman who has not completed lumbopelvic recovery Orthopedic disorders of the lower limb that may prevent satisfactory adjustment of Keeogo Uncontrolled epilepsy or tremors Uncontrolled autonomic dysreflexia Severe balance disorders, neurological disorders (any condition that prevents the safe control of balance and/or movement of the limbs at all times while wearing the Keeogo System) Conditions that prevent safe moderate-intensity exercise
Sites / Locations
- Hospices Civils de Lyon - Hôpital Henry Gabrielle
- Pôle Saint Hélier
- Hôpital Saint Philibert-Groupement des Hôpitaux de l'Institut Catholique de Lille
- Centre de rééducation Fonctionnelle Propara-Montpellier
- CHU Angers- SSR Les Capucins
- CHU Nantes site de Saint Jacques
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Arm A
Arm B
Arm Description
8 weeks of using keeogo at home (experimental phase) followed by 8 weeks of wash-up and then followed by 8 weeks of recommended home practise (control phase).
8 weeks of recommended home practise (control phase) followed by 8 weeks of wash-up and then followed by 8 weeks of using keeogo at home (experimental phase)
Outcomes
Primary Outcome Measures
Evolution of the quality of life assessed with the "Functional Assessment Of Multiple Sclerosis" questionnaire (change between two time points)
The Functional Assessment Of Multiple Sclerosis (FAMS) is a self-administered health questionnaire related to quality of life for patients with multiple sclerosis
Secondary Outcome Measures
Walking and balancing performance with the Keeogo exoskeleton (1)
Measured by 2 minutes walking test
Walking and balancing performance with the Keeogo exoskeleton (2)
Measured by 10 meter walking test
Walking and balancing performance with the Keeogo exoskeleton (3)
Measured by the Timed up and go Test
Walking and balancing performance with the Keeogo exoskeleton (4)
Measured by Functional Stair Test (FST)
Walking and balancing performance with the Keeogo exoskeleton (5)
Measured by the Sit to Stand Test (SST)
Walking and balancing performance with the Keeogo exoskeleton (6)
Evaluations of spatio-temporal gait parameters using an instrumented walking system (Gaitrite®, Vicon® or Locometer® for example)
Spasticity of the quadriceps, hamstrings and abductors muscles
Assessed manually by the Held and Tardieu Test
Sense of self-efficacy
Measured by the Rosenberg Self-Efficacy Questionnaire
The average daily distance travelled
Measured by inertial units tracing the daily activity of the participants (descriptive daily distance travelled)
Fatigue
Measured by the French version of the fatigue impact scale in multiple sclerosis (EMIF-SEP) scored from 0 to 100% a low score is a better outcome
Anxiety and depression
Measured by the Hospital Anxiety and Depression score (HAD) scored from 0 to 21 for both subtitles (Anxiety and depression) a low score is a better outcome
Satisfaction with this new home technical aid
Evaluated via the French version of the QUEST questionnaire (ESAT questionnaire)
Projection in use
Evaluated by a usage questionnaire (UTAUT-based already used in a walking exoskeleton context)
Walking and balancing performance without exoskeleton (1)
Measured by the 2 minutes walking test
Walking and balancing performance without exoskeleton (2)
Measured by the 10 meter walking test
Walking and balancing performance without exoskeleton (3)
Measured by the Timed up and go Test
Walking and balancing performance without exoskeleton (4)
Measured by the Functional Stair Test (FST)
Walking and balancing performance without exoskeleton (5)
Measured by the Sit to Stand Test (SST)
Walking and balancing performance without exoskeleton (6)
Evaluations of spatio-temporal gait parameters using an instrumented walking system (Gaitrite®, Vicon® or Locometer® for example)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05835622
Brief Title
Clinical Investigation of the Quality of Life Benefit of Using a Home Walking Exoskeleton for a Population of Multiple Sclerosis Patients.
Acronym
EXHOMESEP
Official Title
Clinical Investigation of the Quality of Life Benefit of Using a Home Walking Exoskeleton for a Population of Multiple Sclerosis Patients With Gait Disorders.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 2, 2023 (Anticipated)
Primary Completion Date
February 2026 (Anticipated)
Study Completion Date
February 2, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pôle Saint Hélier
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goal of this clinical investigation is to evaluate the effectiveness of home use of a lightweight robotic lower limb exoskeleton as a walking aid device on quality of life in patients with multiple sclerosis with gait disorders.
Participants will wear an exoskeleton (Keeogo) for 8 weeks at home during the experimental phase. This phase is compared to an 8-week control phase at home with advice on regular physical activity adapted to their abilities.
Detailed Description
It is a multicenter, controlled, randomized, cross-over, open-label clinical investigation.
Patients with multiple sclerosis with an Expanded Disability Status Scale (EDSS) between 5 and 6.5,living at home and using an assistive device for walking will be included.
After enrollment, patients will be randomised in one of the 2 study-arm.
Arm A: experimental phase / Wash-Out (WO) (8 weeks) / control phase
Arm B: control phase / WO (8 weeks) / experimental phase
During the experimental phase, patients will receive a Keeogo specific training for five days. The purpose of this training programme is to ensure familiarity and acceptance of the device. Then, the patients will take Keeogo home and will have to use the device as much as possible indoors and outdoors for seven weeks.
During the control phase, patients will be at home for eight weeks with advice on regular physical activity adapted to their abilities.
After the second phase, all patients will have a 3 months of follow-up.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
After screening visit, patients are randomised between two Arms. Patients in Arm A start with experimental phase and after a wash-out period start the control phase (without exoskeleton). Patients randomised in Arm B start with the control phase and after the wash-out period start the experimental phase. After that, all patients have a follow-up period.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm A
Arm Type
Other
Arm Description
8 weeks of using keeogo at home (experimental phase) followed by 8 weeks of wash-up and then followed by 8 weeks of recommended home practise (control phase).
Arm Title
Arm B
Arm Type
Other
Arm Description
8 weeks of recommended home practise (control phase) followed by 8 weeks of wash-up and then followed by 8 weeks of using keeogo at home (experimental phase)
Intervention Type
Device
Intervention Name(s)
Keeogo
Intervention Description
Keeogo is exoskeleton for walking assistance
Intervention Type
Other
Intervention Name(s)
adviced home practice
Intervention Description
health tips for regular and appropriate physical activity
Primary Outcome Measure Information:
Title
Evolution of the quality of life assessed with the "Functional Assessment Of Multiple Sclerosis" questionnaire (change between two time points)
Description
The Functional Assessment Of Multiple Sclerosis (FAMS) is a self-administered health questionnaire related to quality of life for patients with multiple sclerosis
Time Frame
Screening visit and visit after experimental phase (Week 8 for Arm A; Week 24 for Arm B)
Secondary Outcome Measure Information:
Title
Walking and balancing performance with the Keeogo exoskeleton (1)
Description
Measured by 2 minutes walking test
Time Frame
after experimental phase (Week 8 for Arm A; Week 24 for Arm B)
Title
Walking and balancing performance with the Keeogo exoskeleton (2)
Description
Measured by 10 meter walking test
Time Frame
after experimental phase (Week 8 for Arm A; Week 24 for Arm B)
Title
Walking and balancing performance with the Keeogo exoskeleton (3)
Description
Measured by the Timed up and go Test
Time Frame
after experimental phase (Week 8 for Arm A; Week 24 for Arm B)
Title
Walking and balancing performance with the Keeogo exoskeleton (4)
Description
Measured by Functional Stair Test (FST)
Time Frame
after experimental phase (Week 8 for Arm A; Week 24 for Arm B)
Title
Walking and balancing performance with the Keeogo exoskeleton (5)
Description
Measured by the Sit to Stand Test (SST)
Time Frame
after experimental phase (Week 8 for Arm A; Week 24 for Arm B)
Title
Walking and balancing performance with the Keeogo exoskeleton (6)
Description
Evaluations of spatio-temporal gait parameters using an instrumented walking system (Gaitrite®, Vicon® or Locometer® for example)
Time Frame
after experimental phase (Week 8 for Arm A; Week 24 for Arm B)
Title
Spasticity of the quadriceps, hamstrings and abductors muscles
Description
Assessed manually by the Held and Tardieu Test
Time Frame
At all study visits (Screening, Week 8, Week 16, Week 24, Month 9)
Title
Sense of self-efficacy
Description
Measured by the Rosenberg Self-Efficacy Questionnaire
Time Frame
At all study visits (Screening, Week 8, Week 16, Week 24, Month 9)
Title
The average daily distance travelled
Description
Measured by inertial units tracing the daily activity of the participants (descriptive daily distance travelled)
Time Frame
At study visits (Week 8, Week 24, Month 9)
Title
Fatigue
Description
Measured by the French version of the fatigue impact scale in multiple sclerosis (EMIF-SEP) scored from 0 to 100% a low score is a better outcome
Time Frame
At all study visits (Screening, Week 8, Week 16, Week 24, Month 9)
Title
Anxiety and depression
Description
Measured by the Hospital Anxiety and Depression score (HAD) scored from 0 to 21 for both subtitles (Anxiety and depression) a low score is a better outcome
Time Frame
At all study visits (Screening, Week 8, Week 16, Week 24, Month 9)
Title
Satisfaction with this new home technical aid
Description
Evaluated via the French version of the QUEST questionnaire (ESAT questionnaire)
Time Frame
After experimental phase (Week 8 for Arm A; Week 24 for Arm B)
Title
Projection in use
Description
Evaluated by a usage questionnaire (UTAUT-based already used in a walking exoskeleton context)
Time Frame
After experimental phase (Week 8 for Arm A; Week 24 for Arm B)
Title
Walking and balancing performance without exoskeleton (1)
Description
Measured by the 2 minutes walking test
Time Frame
At all study visits (Screening, Week 8, Week 16, Week 24, Month 9)
Title
Walking and balancing performance without exoskeleton (2)
Description
Measured by the 10 meter walking test
Time Frame
At all study visits (Screening, Week 8, Week 16, Week 24, Month 9)
Title
Walking and balancing performance without exoskeleton (3)
Description
Measured by the Timed up and go Test
Time Frame
At all study visits (Screening, Week 8, Week 16, Week 24, Month 9)
Title
Walking and balancing performance without exoskeleton (4)
Description
Measured by the Functional Stair Test (FST)
Time Frame
At all study visits (Screening, Week 8, Week 16, Week 24, Month 9)
Title
Walking and balancing performance without exoskeleton (5)
Description
Measured by the Sit to Stand Test (SST)
Time Frame
At all study visits (Screening, Week 8, Week 16, Week 24, Month 9)
Title
Walking and balancing performance without exoskeleton (6)
Description
Evaluations of spatio-temporal gait parameters using an instrumented walking system (Gaitrite®, Vicon® or Locometer® for example)
Time Frame
At all study visits (Screening, Week 8, Week 16, Week 24, Month 9)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient with multiple sclerosis according to the revised Mac Donald diagnostic criteria (2017) in the relapsing-remitting form more than 6 months from a relapsing or progressive period.
An Expanded Disability Status Scale (EDSS) between 5 and 6.5 on the EDSS scale (Kurtzke 1983)
Living at home
Using a walking aid
18 years old or older
Have freely consented to participate in this study
To be more than 1m52 tall
Hip Manual Muscle Testing (MMT) score ≥ 3+ (flexors and expanders)
Knee Manual Muscle Testing (MMT) score ≥ 2 (flexors and expanders)
Berg scale (BBS) score > 20
Patient affiliated with a social security plan or beneficiary of such a plan.
Non-Inclusion Criteria:
Impaired comprehension preventing completion of the protocol
Inability to walk without assistance for 10 minutes
Have a rehabilitation stay scheduled during the follow-up period of the clinical investigation
Diagnosed psychiatric conditions that may have an impact on the experience of withdrawal of technical assistance at the end of the protocol
Severe cognitive impairment (MMSE<24)
Person deprived of liberty by a judicial or administrative decision
A person under psychiatric care or admitted to a health or social institution for purposes other than research.
Spasticity >3 on the Held and Tardieu scale affecting the hamstring, quadriceps, adductor or sural triceps muscles
Complete paralysis of the lower limbs
Severe osteoporosis
Hip and/or knee replacements that would sufficiently limit range of motion for walking and sitting or squatting
Severe vascular disorders of the lower limbs
Existing wounds or skin lesions where the device is worn
Pregnant woman or postpartum woman who has not completed lumbopelvic recovery
Orthopedic disorders of the lower limb that may prevent satisfactory adjustment of Keeogo
Uncontrolled epilepsy or tremors
Uncontrolled autonomic dysreflexia
Severe balance disorders, neurological disorders (any condition that prevents the safe control of balance and/or movement of the limbs at all times while wearing the Keeogo System)
Conditions that prevent safe moderate-intensity exercise
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Phillipe Gallien, Doctor
Phone
0299295099
Ext
+33
Email
philippe.gallien@pole-sthelier.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Gallien, Doctor
Organizational Affiliation
Pole Saint-Hélier
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospices Civils de Lyon - Hôpital Henry Gabrielle
City
Saint Genis Laval
State/Province
Auvergne-Rhône-Alpes
ZIP/Postal Code
69230
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophie Jacquin-Courtois, Doctor
Facility Name
Pôle Saint Hélier
City
Rennes
State/Province
Bretagne
ZIP/Postal Code
35000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe Gallien, Doctor
Facility Name
Hôpital Saint Philibert-Groupement des Hôpitaux de l'Institut Catholique de Lille
City
Lomme
State/Province
Hauts-de-France
ZIP/Postal Code
59160
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cecile Donze, Doctor
Facility Name
Centre de rééducation Fonctionnelle Propara-Montpellier
City
Montpellier
State/Province
Occitanie
ZIP/Postal Code
34090
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anthony Gelis, Doctor
Facility Name
CHU Angers- SSR Les Capucins
City
Angers
State/Province
Pays De La Loire
ZIP/Postal Code
49103
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mickael Dinomais, Doctor
Facility Name
CHU Nantes site de Saint Jacques
City
Nantes
State/Province
Pays De La Loire
ZIP/Postal Code
44093
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre Kieny, Doctor
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Investigation of the Quality of Life Benefit of Using a Home Walking Exoskeleton for a Population of Multiple Sclerosis Patients.
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