WheelchairNCT03354949
Base Positioning Wheelchair Hemiplegic
An observational study of Wheelchair, run by Groupement Hospitalier Intercommunal du Vexin.
Trial summary
The investigators looked at the population of hemiplegic stroke participants hospitalized with GHIV : the investigators assessed the postural control of the participants of the chair using MCPAA, and assessed the pain of the participants while sitting in a wheelchair. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Wheelchair
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2016to 11 Feb 2020
- Phase
- Observational
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Positioning of all hemiplegics by stroke requiring a wheelchair even punctual at the exit of the SSR compared to patients with hemiplegic sequelae.
Who may be able to join
- Hemiplegia by stroke
- Wheelchair user
Who cannot join
- Two-handed propulsion of the wheelchair
- Cognitive impairment preventing clinical examination
About this study
Official title: Postural Wheelchair Control in Hemiplegic Stroke Patients
The investigators looked at the population of hemiplegic stroke participants hospitalized with GHIV : the investigators assessed the postural control of the participants of the chair using MCPAA, and assessed the pain of the participants while sitting in a wheelchair. The investigators then had to the participants try positioning equipment and then prescribed it once the choice was made. The investigators then reassessed postural control and wheelchair pain with this positioning equipment.
Read the detailed description
For each hemiplegic participants with wheelchair user stroke, the investigators collect : date of birth, date of stroke, side of hemiplegia. The wheelchair propulsion mode, the degree of autonomy (FAC and Enjalber scales), the way bed - wheelchair transfers are made. Assessment of wheelchair pain in the spine and Ischia with EVA. Time to travel 10 meters in a wheelchair. Postural control of the wheelchair is evaluated by the MCPAA. The investigators then carry out tests of positioning equipment : backrest, cushion, form elements and belt. This material is tried for several days. If it is appropriate (improvement on the postural control and on the pains), otherwise another material is tried.
When the choice is made, the material is prescribed. The participant is seen again 3 months after the delivery of his personal material, and the same evaluation is redone.
- Conditions
- Wheelchair
- Being tested
- Measurement of sitting postural control of the adult (MCPAA)
- Keywords
- Wheelchair, Hemiplegia, Stroke, Postural control, Pain
- Medical subject headings
- Hemiplegia, Stroke, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of sitting postural control of the adult (MCPAA)Other
The Adult Seated Postural Control Measure 2.0 (MCPAA 2.0) is a clinical evaluation tool for sitting postural control of adult clients using a locomotion aid. It thus allows the evaluation of the two variables inherent to the postural control sit, the alignment of body segments and the influence between movement and posture.
It can also be used to evaluate the changes in seated postural control due to changes over time or to an adaptation of the sitting posture.
Assessment of wheelchair pain in the spine and ischia by a self-evaluation scale (EVA).
the speed of propulsion by a wheelchair.
| Study group | Role | What they receive |
|---|---|---|
| Positioning hemiplegic. | Positioning all hemiplegic by stroke requiring a single wheelchair even at the exit of the SSR and hemiplegic patient with sequelae.
Measurement of sitting postural control of the adult (MCPAA). Assessment of wheelchair pain in the spine and ischia by a self-evaluation scale (EVA).
Propulsion speed of a wheelchair. Receives: Other: Measurement of sitting postural control of the adult (MCPAA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study the improvement of the basin retroversion.
The Adult Seated Postural Control Measure 2.0 (MCPAA 2.0) is a clinical evaluation tool for sitting postural control of adult clients using a locomotion aid. It thus allows the evaluation of the two variables inherent to the postural control sit, the alignment of body segments and the influence between movement and posture. It can also be used to evaluate the changes in seated postural control due to changes over time or to an adaptation of the sitting posture.
Measured: Through study completion, an average of one year.
Secondary outcomes (2)
The tilt.
Assessment of wheelchair pain in the spine and ischia by a self-evaluation scale (EVA). The self-evaluation scale (EVA) is used to assess participant pain.
It is in the form of a straight line of 100 mm. This scale is composed on the reverse side of a horizontal line from "no pain" to "maximum pain imaginable". The left side corresponds to "no pain", the right end corresponds to "maximum pain imaginable". The participant indicates, with the cursor, his level of pain on the line. The pain score is displayed on the front of the scale.
Measured: Through study completion, an average of one year.
Propulsion speed.
The propelling speed of the wheelchair.
Measured: Through study completion, an average of one year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2017
- Study start1 Sep 2016
- Primary completion11 Feb 2020
- Study completion11 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WheelchairStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupement Hospitalier Intercommunal du Vexin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nadine PELLIGRINI, Principal investigator, Groupe Hospitalier Intercommunal du Vexin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03354949
- Sponsor's protocol ID
- GHIV0117
- Status last verified
- Feb 2021
- First submitted
- 17 Nov 2017
- Last updated
- 21 Feb 2021
- 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 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postural Wheelchair Control in Hemiplegic Stroke Patients
- ClinicalTrials.gov ID
- NCT03354949
- Acronym / sponsor ID
- GHIV0117
- Conditions
- Wheelchair
- Keywords
- Wheelchair, Hemiplegia, Stroke, Postural control, Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Groupement Hospitalier Intercommunal du VexinUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 11 Feb 2020 (actual)
- Study completion
- 11 Feb 2020 (actual)
- First posted
- 28 Nov 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.
The investigators looked at the population of hemiplegic stroke participants hospitalized with GHIV : the investigators assessed the postural control of the participants of the chair using MCPAA, and assessed the pain of the participants while sitting in a wheelchair. The investigators then had to the participants try positioning equipment and then prescribed it once the choice was made. The investigators then reassessed postural control and wheelchair pain with this positioning equipment.
Detailed description
For each hemiplegic participants with wheelchair user stroke, the investigators collect : date of birth, date of stroke, side of hemiplegia. The wheelchair propulsion mode, the degree of autonomy (FAC and Enjalber scales), the way bed - wheelchair transfers are made. Assessment of wheelchair pain in the spine and Ischia with EVA. Time to travel 10 meters in a wheelchair. Postural control of the wheelchair is evaluated by the MCPAA. The investigators then carry out tests of positioning equipment : backrest, cushion, form elements and belt. This material is tried for several days. If it is appropriate (improvement on the postural control and on the pains), otherwise another material is tried.
When the choice is made, the material is prescribed. The participant is seen again 3 months after the delivery of his personal material, and the same evaluation is redone.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Positioning hemiplegic. | – | Other: Measurement of sitting postural control of the adult (MCPAA)Positioning all hemiplegic by stroke requiring a single wheelchair even at the exit of the SSR and hemiplegic patient with sequelae. Measurement of sitting postural control of the adult (MCPAA). Assessment of wheelchair pain in the spine and ischia by a self-evaluation scale (EVA). Propulsion speed of a wheelchair. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Positioning of all hemiplegics by stroke requiring a wheelchair even punctual at the exit of the SSR compared to patients with hemiplegic sequelae.
Key inclusion criteria (2 listed)
- Hemiplegia by stroke
- Wheelchair user
Key exclusion criteria (2 listed)
- Two-handed propulsion of the wheelchair
- Cognitive impairment preventing clinical examination
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 |
|---|---|---|
| Measurement of sitting postural control of the adult (MCPAA)The Adult Seated Postural Control Measure 2.0 (MCPAA 2.0) is a clinical evaluation tool for sitting postural control of adult clients using a locomotion aid. It thus allows the evaluation of the two variables inherent to the postural control sit, the alignment of body segments and the influence between movement and posture. It can also be used to evaluate the changes in seated postural control due to changes over time or to an adaptation of the sitting posture. Assessment of wheelchair pain in the spine and ischia by a self-evaluation scale (EVA). the speed of propulsion by a wheelchair. | Other | Positioning hemiplegic. |
Primary outcome
Study the improvement of the basin retroversion.
Time frame: Through study completion, an average of one year.
The Adult Seated Postural Control Measure 2.0 (MCPAA 2.0) is a clinical evaluation tool for sitting postural control of adult clients using a locomotion aid. It thus allows the evaluation of the two variables inherent to the postural control sit, the alignment of body segments and the influence between movement and posture. It can also be used to evaluate the changes in seated postural control due to changes over time or to an adaptation of the sitting posture.
2 secondary outcomes
The tilt.
Time frame: Through study completion, an average of one year.
Propulsion speed.
Time frame: Through study completion, an average of one year.
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 21 Feb 2021.
- Individual participant dataSharing planned: No
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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.
Nadine PELLIGRINI principal investigator
Groupe Hospitalier Intercommunal du Vexin
Questions about this trial
What is this clinical trial studying?
An observational study of Wheelchair, run by Groupement Hospitalier Intercommunal du Vexin.
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 2 inclusion and 2 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 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Study the improvement of the basin retroversion. (time frame: Through study completion, an average of one year.). 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 21 Feb 2021.