Seated - Standing Passage of the Hemiplegic — PADH2  

Hemiplegia Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Hemiplegia

• NCT number: NCT03117699
• Study type: Interventional
• Source: University Hospital, Brest
• Status: Completed
• Phase: N/A
• Start date: April 13, 2017
• Completion date: April 13, 2018