Seated - Standing Passage of the Hemiplegic (PADH2)

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

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.

Study Overview

• Status: Completed
• Conditions: Hemiplegia
• Intervention / Treatment: Device: New device for seated-standing passages

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Brest, France, 29200
    • Brest University Hospital
  • Ploemeur, France, 56000
    • Centre de rééducation fonctionnelle de KERPAPE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Record of all adverse reactions.	The safety of the devices will be evaluated by the occurrence of adverse reactions.	Day 1

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2017
• Primary Completion (Actual): April 13, 2018
• Study Completion (Actual): April 13, 2018

Study Registration Dates

• First Submitted: March 29, 2017
• First Submitted That Met QC Criteria: April 12, 2017
• First Posted (Actual): April 18, 2017

Study Record Updates

• Last Update Posted (Actual): March 4, 2022
• Last Update Submitted That Met QC Criteria: March 3, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Hemiplegia; transport device
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Paralysis; Hemiplegia
• Other Study ID Numbers: 29BRC16.0012 PADH2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No