Seated - Standing Passage of the Hemiplegic
- Conditions
- Hemiplegia
- Interventions
- Device: New device for seated-standing passages
- Registration Number
- NCT03117699
- Lead Sponsor
- University Hospital, Brest
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Healthy volunteers New device for seated-standing passages 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 Hemiplegic subjects New device for seated-standing passages 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
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Record of all adverse reactions. Day 1 The safety of the devices will be evaluated by the occurrence of adverse reactions.
Trial Locations
- Locations (2)
Centre de rééducation fonctionnelle de KERPAPE
🇫🇷Ploemeur, France
Brest University Hospital
🇫🇷Brest, France