Seated - Standing Passage of the Hemiplegic (PADH2)
Primary Purpose
Hemiplegia
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
New device for seated-standing passages
Sponsored by
About this trial
This is an interventional device feasibility trial for Hemiplegia focused on measuring Hemiplegia, transport device
Eligibility Criteria
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)
Sites / Locations
- Brest University Hospital
- Centre de rééducation fonctionnelle de KERPAPE
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Hemiplegic subjects
Healthy volunteers
Arm Description
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
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
Outcomes
Primary Outcome Measures
Time required to carry out each step of use of the device
Each step of phase 1 and phase 2 will be timed.
Secondary Outcome Measures
Record of all adverse reactions.
The safety of the devices will be evaluated by the occurrence of adverse reactions.
Full Information
NCT ID
NCT03117699
First Posted
March 29, 2017
Last Updated
March 3, 2022
Sponsor
University Hospital, Brest
1. Study Identification
Unique Protocol Identification Number
NCT03117699
Brief Title
Seated - Standing Passage of the Hemiplegic
Acronym
PADH2
Official Title
Continuation of the Exploration of the Standing Seated Passage of the Hemiplegic for the Realization of a New Transport Device
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
April 13, 2017 (Actual)
Primary Completion Date
April 13, 2018 (Actual)
Study Completion Date
April 13, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiplegia
Keywords
Hemiplegia, transport device
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hemiplegic subjects
Arm Type
Experimental
Arm Description
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
Arm Title
Healthy volunteers
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
New device for seated-standing passages
Intervention Description
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
Primary Outcome Measure Information:
Title
Time required to carry out each step of use of the device
Description
Each step of phase 1 and phase 2 will be timed.
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Record of all adverse reactions.
Description
The safety of the devices will be evaluated by the occurrence of adverse reactions.
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Facility Information:
Facility Name
Brest University Hospital
City
Brest
ZIP/Postal Code
29200
Country
France
Facility Name
Centre de rééducation fonctionnelle de KERPAPE
City
Ploemeur
ZIP/Postal Code
56000
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
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Seated - Standing Passage of the Hemiplegic
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