Clinical Investigation of the Quality of Life Benefit of Using a Home
Clinical Investigation of the Quality of Life Benefit of Using a Home Walking Exoskeleton for a Population of Multiple Sclerosis Patients With Gait Disorders.
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Keeogo
- adviced home practice
What it measured
Main measures
Evolution of the quality of life assessed with the "Functional Assessment Of Multiple Sclerosis" questionnaire (change between two time points)
Screening visit and visit after experimental phase (Week 8 for Arm A; Week 24 for Arm B)
Quality of life (reported by participants)
Other measures (19)
Walking and balancing performance with the Keeogo exoskeleton (1)
after experimental phase (Week 8 for Arm A; Week 24 for Arm B)
Walking and mobilityWalking and balancing performance with the Keeogo exoskeleton (2)
after experimental phase (Week 8 for Arm A; Week 24 for Arm B)
Walking and mobilityWalking and balancing performance with the Keeogo exoskeleton (3)
after experimental phase (Week 8 for Arm A; Week 24 for Arm B)
Walking and mobilityWalking and balancing performance with the Keeogo exoskeleton (4)
after experimental phase (Week 8 for Arm A; Week 24 for Arm B)
Walking and mobilityWalking and balancing performance with the Keeogo exoskeleton (5)
after experimental phase (Week 8 for Arm A; Week 24 for Arm B)
Walking and mobilityWalking and balancing performance with the Keeogo exoskeleton (6)
after experimental phase (Week 8 for Arm A; Week 24 for Arm B)
Walking and mobilitySpasticity of the quadriceps, hamstrings and abductors muscles
At all study visits (Screening, Week 8, Week 16, Week 24, Month 9)
SpasticitySense of self-efficacy
At all study visits (Screening, Week 8, Week 16, Week 24, Month 9)
The average daily distance travelled
At study visits (Week 8, Week 24, Month 9)
Fatigue
At all study visits (Screening, Week 8, Week 16, Week 24, Month 9)
Fatigue
Who could take part
Relapsing MS · 18 and over · EDSS 5 to 6.5
Show the full 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
Exclusion criteria
Not separately supplied in the registry.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Loading reviews and guidelines…
History
Started
Feb 2024
Main results due
Sept 2026
Finished
Sept 2026