Clinical trial NCT03117699: Seated - Standing Passage of the Hemiplegic
Official title: Continuation of the Exploration of the Standing Seated Passage of the Hemiplegic for the Realization of a New Transport Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemiplegia
Keywords: Hemiplegia
transport device
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2017-04-18
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DEVICE_FEASIBILITY

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Time required to carry out each step of use of the device
timeFrame: Day 1
Secondary outcomes:
measure: Record of all adverse reactions.
timeFrame: Day 1
Other outcomes:
Locations:
city: Brest
country: France
facility: Brest University Hospital
city: Ploemeur
country: France
facility: Centre de rééducation fonctionnelle de KERPAPE
Study officials:
References: