NCT03117699

Seated - Standing Passage of the Hemiplegic

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: University Hospital, Brest · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hemiplegia

Interventions

Type	Name	Description
DEVICE	New 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

Timeline

• Start date: 2017-04-13
• Primary completion: 2018-04-13
• Completion: 2018-04-13
• First posted: 2017-04-18
• Last updated: 2022-03-04

Locations

2 sites across 1 country: France