- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03354949
Base Positioning Wheelchair Hemiplegic
Postural Wheelchair Control in Hemiplegic Stroke Patients
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Hemiplegia by stroke
- Wheelchair user
Exclusion Criteria:
- Two-handed propulsion of the wheelchair
- Cognitive impairment preventing clinical examination
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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. |
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Through study completion, an average of one year.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The tilt.
Time Frame: Through study completion, an average of one year.
|
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. |
Through study completion, an average of one year.
|
|
Propulsion speed.
Time Frame: Through study completion, an average of one year.
|
The propelling speed of the wheelchair.
|
Through study completion, an average of one year.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Nadine PELLIGRINI, Groupe Hospitalier Intercommunal du Vexin
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- GHIV0117
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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