Seated - Standing Passage of the Hemiplegic

Study Overview
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Brief Summary
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This is a study for a new mechanical transport device adapted to the hemiplegic patients. Healthy volunteers : After explaining the protocol and presenting the movement laboratory, the subjects are equipped with reflective markers on the 4 limbs, the trunk and the head. The subjects are installed on a seat positioned in front of 2 force platforms installed on the ground. The seat is equipped with a force platform. Phase 1 : After being seated, the subject realizes : 3 seat to stand and stand to seat without assistance 3 seat to stand and stand to seat using a handle located in front of it (handle equipped with a 6-axis force sensor) 3 seat to stand and stand to seat using the experimental device This phase will last 45minutes (mn) (30mn of equipment and 15mn of sitting passengers standing) Phase 2: After being seated, the subject performs a course comprising: A standing pass from sitting on a chair A straight line movement A succession of left and right turns An upward and downward travel of less than 1%. Standard doorway Standing on the toilet A sitting pass from the toilet One way to a bed A sitting pass on the bed A passenger seat sitting upright from the bed A return to the starting point A sitting pass on the starting chair Each stage is timed. A subjective analysis of each step is done by a lickert scale on the perceived comfort and safety. This phase 2 will last 30mn (15mn of course and 15mn of questions). Hemiplegic subjects : At each session, the subject is examined by a physician who evaluates the motor control (Fugl Meyer scale), the equilibrium (Berg scale) and the spatial hemineglect (Bergego scale). Phase 1 is performed except the 3 seat to stand and stand to seat without assistance which are impossible. Phase 2 is performed. An evaluation of the device over 4 hours is carried out for each subject in therapeutic apartment in simulated living conditions. The validation in living lab is carried out by an ergonomist and by a questionnaire on the comfort and safety of the various steps identified by the ergonomist.

Official Title
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Continuation of the Exploration of the Standing Seated Passage of the Hemiplegic for the Realization of a New Transport Device

Conditions
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Hemiplegia

Intervention / Treatment
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* Device: New device for seated-standing passages


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteers : aged 18-75 years Subject having given his consent Free from any neurological or cardiorespiratory locomotor pathology that may interfere with standing seated passages. Hemiplegic patients : Left hemiplegia in one of the following groups : Walking with difficulty or not walking and able to stand with a stick or an armrest Walking difficult or not walking and unable to stand with a cane or an armrest. aged 18-90 years Subject having given his consent Subjects with a trunk balance to sit without support Exclusion Criteria: aged less than 18 or more than 75 (healthy volunteers) or more than 90 (hemiplegic subjects) Pain during seated-standing passages Unstable medical condition Unable to consent Subject under legal protection Left-hemineglect making standing or seated (wheelchair) displacements impossible autonomously (for hemiplegic patients)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hemiplegic subjects<br>Testing of a new device for seated-standing passages after undergoing medical evaluation included Fugl Meyer scale, Berg scale and Bergego scale. Phase 1 : 3 seated-standing passages with a handle equipped with 6 force captors 3 seated-standing passages with the device | Device: New device for seated-standing passages<br>* Phase 1 : The subject perform different seated-standing passages (see Arm) Phase 2 : After being seated, the subject performs a course comprising: A standing pass from sitting on a chair A straight line movement A succession of left and right turns An upward and downward travel of less than 1%. Standard doorway Standing on the toilet A sitting pass from the toilet One way to a bed A sitting pass on the bed A passenger seat sitting upright from the bed A return to the starting point A sitting pass on the starting chair<br>|
| Experimental: Healthy volunteers<br>Testing of a new device for seated-standing passages . Phase 1 : 3 seated-standing passages without help 3 seated-standing passages with a handle equipped with 6 force captors 3 seated-standing passages with the device | Device: New device for seated-standing passages<br>* Phase 1 : The subject perform different seated-standing passages (see Arm) Phase 2 : After being seated, the subject performs a course comprising: A standing pass from sitting on a chair A straight line movement A succession of left and right turns An upward and downward travel of less than 1%. Standard doorway Standing on the toilet A sitting pass from the toilet One way to a bed A sitting pass on the bed A passenger seat sitting upright from the bed A return to the starting point A sitting pass on the starting chair<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time required to carry out each step of use of the device | Each step of phase 1 and phase 2 will be timed. | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Record of all adverse reactions. | The safety of the devices will be evaluated by the occurrence of adverse reactions. | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemiplegia, transport device