Hemiplegia
Conditions
Keywords
Hemiplegia, transport device
Brief summary
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.
Interventions
DEVICENew device for seated-standing passages
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
Sponsors
University Hospital, Brest
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time required to carry out each step of use of the device | Day 1 | Each step of phase 1 and phase 2 will be timed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Record of all adverse reactions. | Day 1 | The safety of the devices will be evaluated by the occurrence of adverse reactions. |
Countries
France
Outcome results
None listed