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Seated - Standing Passage of the Hemiplegic

NCT03117699 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2022-03-04

No results posted yet for this study

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

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

Sponsors & Collaborators

  • University Hospital, Brest

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-04-13
Primary Completion
2018-04-13
Completion
2018-04-13

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03117699 on ClinicalTrials.gov