PADH2: Seated - Standing Passage of the Hemiplegic

Sponsor

University Hospital, Brest (Other)

Overall Status

Completed

CT.gov ID

NCT03117699

Collaborator

(none)

Enrollment

Locations

Arms

Actual Duration (Months)

22.5

Patients Per Site

1.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hemiplegia	Device: New device for seated-standing passages	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

45 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Device Feasibility

Official Title:

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

Actual Study Start Date :

Apr 13, 2017

Actual Primary Completion Date :

Apr 13, 2018

Actual Study Completion Date :

Apr 13, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Hemiplegic subjects 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	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
Experimental: Healthy volunteers 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	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

Arm

Intervention/Treatment

Experimental: Hemiplegic subjects

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

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

Experimental: Healthy volunteers

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

Device: New device for seated-standing passages

Outcome Measures

Primary Outcome Measures

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

Record of all adverse reactions. [Day 1]
The safety of the devices will be evaluated by the occurrence of adverse reactions.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Brest University Hospital	Brest		France	29200
2	Centre de rééducation fonctionnelle de KERPAPE	Ploemeur		France	56000

Sponsors and Collaborators

University Hospital, Brest

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Brest

ClinicalTrials.gov Identifier:

NCT03117699

Other Study ID Numbers:

29BRC16.0012 PADH2

First Posted:

Apr 18, 2017

Last Update Posted:

Mar 4, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Hospital, Brest

Hemiplegia

transport device

Additional relevant MeSH terms:

Hemiplegia

Study Results

No Results Posted as of Mar 4, 2022