HemiplegiaPADH2NCT03117699
Seated - Standing Passage of the Hemiplegic
A study testing New device for seated-standing passages in people with Hemiplegia, run by University Hospital, Brest at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hemiplegia
- What is being tested?
- New device for seated-standing passages
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesFrance
- Study dates
- 13 Apr 2017to 13 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 :
Show all 11Show fewer
- 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
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
France2 sites
Brest University Hospital
Brest, 29200
Centre de rééducation fonctionnelle de KERPAPE
Ploemeur, 56000
About this study
Official title: 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 :
Read more
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
- Being tested
- New device for seated-standing passages
- Keywords
- Hemiplegia, transport device
- Medical subject headings
- Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New device for seated-standing passagesDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Hemiplegic subjects | Experimental | 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 Receives: Device: New device for seated-standing passages |
| Healthy volunteers | Experimental | 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 Receives: Device: New device for seated-standing passages |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time required to carry out each step of use of the device
Each step of phase 1 and phase 2 will be timed.
Measured: Day 1
Secondary outcomes (1)
Record of all adverse reactions.
The safety of the devices will be evaluated by the occurrence of adverse reactions.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study start13 Apr 2017
- Primary completion13 Apr 2018
- Study completion13 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemiplegiaStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03117699
- Sponsor's protocol ID
- 29BRC16.0012 PADH2
- Acronym
- PADH2
- Status last verified
- Mar 2022
- First submitted
- 29 Mar 2017
- Last updated
- 4 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuation of the Exploration of the Standing Seated Passage of the Hemiplegic for the Realization of a New Transport Device
- ClinicalTrials.gov ID
- NCT03117699
- Acronym / sponsor ID
- PADH2 / 29BRC16.0012 PADH2
- Conditions
- Hemiplegia
- Keywords
- Hemiplegia, transport device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 13 Apr 2017 (actual)
- Primary completion
- 13 Apr 2018 (actual)
- Study completion
- 13 Apr 2018 (actual)
- First posted
- 18 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hemiplegic subjects | Experimental | Device: New device for seated-standing passagesTesting 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 |
| Healthy volunteers | Experimental | Device: New device for seated-standing passagesTesting 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- aged 18-75 years
- Subject having given his consent
- Free from any neurological or cardiorespiratory locomotor pathology that may interfere with standing seated passages.
- Left hemiplegia in one of the following groups :
- Walking with difficulty or not walking and able to stand with a stick or an armrest
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| New device for seated-standing passagesPhase 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 | Device | Healthy volunteers, Hemiplegic subjects |
Primary outcome
Time required to carry out each step of use of the device
Time frame: Day 1
Each step of phase 1 and phase 2 will be timed.
1 secondary outcome
Record of all adverse reactions.
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2022.
- Individual participant dataSharing planned: No
Related trials for Hemiplegia
Not yet recruiting
Effects of Upper Extremity Physiotherapy and Home Exercises on Functional Outcomes in Individuals With Stroke
Stroke
Recruiting
Task-Oriented Training Versus High-Intensity Gait Training in People With Chronic Stroke
Stroke, Hemiplegia
Active, not recruitingObservational study
Studies of the Variable Phenotypic Presentations of Rapid-Onset Dystonia Parkinsonism and Other Movement Disorders
Dystonia, Parkinsonism
RecruitingObservational study
Post-Stroke Apraxia, Motor Function, Balance, and Gait
Stroke, Ideomotor Apraxia
RecruitingObservational study
Ideomotor Apraxia and Robotic Gait Rehabilitation Outcomes After Stroke
Stroke, Ideomotor Apraxia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New device for seated-standing passages in people with Hemiplegia, run by University Hospital, Brest at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time required to carry out each step of use of the device (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2022.