Seated - Standing Passage of the Hemiplegic

Hemiplegia Clinical Trial

— PADH2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03117699
• Other study ID #: 29BRC16.0012 PADH2
• Status: Completed
• Phase: N/A
• Start date: April 13, 2017
• Est. completion date: April 13, 2018

Study information

• Verified date: March 2022
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: April 13, 2018
• Est. primary completion date: April 13, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Hemiplegia

Intervention

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

Locations

Country	Name	City	State
France	Brest University Hospital	Brest
France	Centre de rééducation fonctionnelle de KERPAPE	Ploemeur

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time required to carry out each step of use of the device	Each step of phase 1 and phase 2 will be timed.	Day 1
Secondary	Record of all adverse reactions.	The safety of the devices will be evaluated by the occurrence of adverse reactions.	Day 1