Hemiplegia And/or Hemiparesis Following StrokePOSIT-HEMINCT04268641

Evaluation of Positioning Protocols on a Wheelchair in Hemiplegic Patients

A study testing Arm 1, Arm 2 and Arm 3 in people with Hemiplegia And/or Hemiparesis Following Stroke, run by Hôpital NOVO at 7 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The main purpose of this study is to assess the interest of using wheelchair positioning equipment on the decrease of postural disorders, compared to the standard use of a wheelchair Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hemiplegia And/or Hemiparesis Following Stroke
What is being tested?: Arm 1, Arm 2 and Arm 3
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 7 sitesFrance
Study dates: 28 Aug 2020to 11 Dec 2023
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
No healthy volunteers
Adult, Older adult

Who may be able to join

Hemiplegic patient following a stroke
Hospitalized in a follow-up and rehabilitative care service, after hospital stays in a MCO service (neurology, neurosurgery or reanimation)
With a planned exit from hospital (homecoming, residential care facilities, nursing home, Long Term Care Unit …)
Patient whose wheelchair choice should be already done
Patient who propels the wheelchair with the valid hand and/or valid foot
Written informed consent (IC) obtained
Patients with affiliation to the social security system

Who cannot join

Good walk recovery (FAC scale >3)
Wheelchair with a double hand rim
Patient who cannot use his2 wheelchair independently
Cognitive disorders which prevent the ability to well understanding the instructions
Other pathology which can interfere with this protocol (Spinal disorder, morbid overweight (BMI>40…)

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

France7 sites

Groupement Hospitalier Intercommunal du Vexin
Aincourt, 95510
Hôpital Raymond Poincaré
Garche, 92380
Institut Régional de Réadaptation
Lay-Saint-Christophe, 54690
Centre de l'ESPOIR
Lille, 59260
Centre de Rééducation L'oiseau Blanc
Mantes-la-Jolie, 78200
Centre de Rééducation et de Réadaptation Fonctionnelles
Menucourt, 95180
Centre Hospitalier Universitaire de Toulouse
Toulouse, 31059

Other trials in France

About this study

Official title: Evaluation of Positioning Protocols with an Adapted Equipment on a Wheelchair in Hemiplegic Patients Following a Stroke

The main purpose of this study is to assess the interest of using wheelchair positioning equipment on the decrease of postural disorders, compared to the standard use of a wheelchair

Read the detailed description

The stroke is the main cause of hemiplegia in developed countries. Fifteen percent of people who say they have a stroke need, at home, a wheelchair to get from one room to another. The use of a wheelchair can cause postural disorders which can lead to pain, orthopedic deformity and pressure ulcers.

This study aims to assess the interest of using wheelchair positioning equipment (Seat back, Positioning cushion and Belt) on the decrease of postural disorders.

This decrease will be assessed after a standardized course, performed under three different conditions: with the positioning equipment (Positioning cushion and Seat back), with the positioning equipment and the belt and with the wheelchair alone.

Clinical tool used to assess the decrease is the Seated Postural Control Measure for Adults 2.0 (SPCMA 2.0).

This study, which will be the first prospective, interventional, multicenter, controlled and randomized study, could pave the way for guidelines of good practice, for wheelchair positioning of hemiplegic patients in France

Conditions: Hemiplegia And/or Hemiparesis Following Stroke
Being tested: Arm 1, Arm 2, Arm 3, Arm 4, Arm 5
Keywords: Hemiplegia, Stroke, Wheelchair positioning, Propulsion, Pelvic posterior tilt, Obliquity
Medical subject headings: Hemiplegia, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Arm 1Other
Materials used for the course :
1. : Standard Wheelchair
2. : Standard Wheelchair + Seat back + Positioning cushion
3. : Standard Wheelchair + Seat back + Positioning cushion + Belt
Arm 2Other
Materials used for the course :
1. : Standard Wheelchair
2. : Standard Wheelchair + Seat back + Positioning cushion + Belt
3. : Standard Wheelchair + Seat back + Positioning cushion
Arm 3Other
Materials used for the course :
1. : Standard Wheelchair + Seat back + Positioning cushion
2. : Standard Wheelchair + Seat back + Positioning cushion + Belt
3. : Standard Wheelchair
Arm 4Other
Materials used for the course :
1. : Standard Wheelchair + Seat back + Positioning cushion
2. : Standard Wheelchair
3. : Standard Wheelchair + Seat back + Positioning cushion + Belt
Arm 5Other
Materials used for the course :
1. : Standard Wheelchair + Seat back + Positioning cushion + Belt
2. : Standard Wheelchair
3. : Standard Wheelchair + Seat back + Positioning cushion
Arm 6Other
Materials used for the course :
1. : Standard Wheelchair + Seat back + Positioning cushion + Belt
2. : Standard Wheelchair + Seat back + Positioning cushion
3. : Standard Wheelchair

Study groups in NCT04268641
Study group	Role	What they receive
Use of positioning equipment order 1	Experimental	One standardized course is performed 3 times by each patient : one with a standard wheelchair and the 2 other with one or two positioning equipment (Seat back or/and positioning cushion) Each arm differs from the previous by the order of use of the equipment. Receives: Other: Arm 1
Use of positioning equipment order 2	Experimental	One standardized course is performed 3 times by each patient : one with a standard wheelchair and the 2 other with one or two positioning equipment (Seat back or/and positioning cushion) Each arm differs from the previous by the order of use of the equipment. Receives: Other: Arm 2
Use of positioning equipment order 3	Experimental	One standardized course is performed 3 times by each patient : one with a standard wheelchair and the 2 other with one or two positioning equipment (Seat back or/and positioning cushion) Each arm differs from the previous by the order of use of the equipment. Receives: Other: Arm 3
Use of positioning equipment order 4	Experimental	One standardized course is performed 3 times by each patient : one with a standard wheelchair and the 2 other with one or two positioning equipment (Seat back or/and positioning cushion) Each arm differs from the previous by the order of use of the equipment. Receives: Other: Arm 4
Use of positioning equipment order 5	Experimental	One standardized course is performed 3 times by each patient : one with a standard wheelchair and the 2 other with one or two positioning equipment (Seat back or/and positioning cushion) Each arm differs from the previous by the order of use of the equipment. Receives: Other: Arm 5
Use of positioning equipment order 6	Experimental	One standardized course is performed 3 times by each patient : one with a standard wheelchair and the 2 other with one or two positioning equipment (Seat back or/and positioning cushion) Each arm differs from the previous by the order of use of the equipment. Receives: Other: Arm 6

What is being measured

The primary outcome is the main question the study is designed to answer.

Degree of pelvic posterior tilt
The Primary Outcome Measure is the variation of the Degree of pelvic posterior tilt at the end of the three standardized course. These courses were performed with Standard Wheelchair, Standard Wheelchair + Seat back + Positioning cushion + Belt or with Standard Wheelchair + Seat back + Positioning cushion.
The Degree of pelvic posterior tilt was measured using the SPCMA 2.0 score (0 = normal, 1 = mild, 2 = moderate and 3 = severe retroversion)
Measured: Immediately after the end of the procedure, an average of 1 day

Secondary outcomes (8)

Variation of Degree of pelvic posterior tilt
The variation of the Degree of pelvic posterior tilt was measured between the beginning and the end of the three standardized course using the SPCMA 2.0 score (0 = normal, 1 = mild, 2 = moderate and 3 = severe retroversion)
Measured: Baseline and immediately after the end of the procedure, an average of 1 day
Variation of degree of lateral inclination of the torso
The variation of the degree of lateral inclination of the torso was measured between the beginning and the end of the three standardized course using the SPCMA 2.0 score (0 = normal, 1 = mild, 2 = moderate and 3 = severe retroversion)
Measured: Baseline and immediately after the end of the procedure, an average of 1 day
Variation of the degree of Pelvis obliquity
The variation of the degree of Pelvis obliquity was measured at the end of the three standardized course using the SPCMA 2.0 score (0 = normal, 1 = mild, 2 =moderate and 3 = severe retroversion)
Measured: Baseline and immediately after the end of the procedure, an average of 1 day
Degree of lateral inclination of the torso
The degree of lateral inclination of the torso was measured at the end of the three standardized course using the SPCMA 2.0 score (0 = normal, 1 = mild, 2 = moderate and 3 = severe retroversion)
Measured: Immediately after the end of the procedure, an average of 1 day
Degree of Pelvis obliquity
The degree of Pelvis obliquity was measured at the end of the three standardized course using the SPCMA 2.0 score (0 = normal, 1 = mild, 2 = moderate and 3 = severe retroversion)
Measured: Immediately after the end of the procedure, an average of 1 day
Measure of patient's satisfaction
The satisfaction of patient was measured with a satisfaction questionnaire scale based on ease of movement, wheelchair comfort and pain during the course. For each item, patient ticks : Very satisfied, Satisfied, Neither satisfied or unsatisfied, Unsatisfied or Very unsatisfied
Measured: Immediately after the end of the procedure, an average of 1 day
Ability to achieve the whole course
Binary criteria (Yes / No)
Measured: Immediately after the end of the procedure, an average of 1 day
Adverse event collect
Total number of adverse event
Measured: Immediately after the end of the procedure, an average of 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Aug 202011 Dec 2023

First posted13 Feb 2020
Study start28 Aug 2020
Primary completion11 Dec 2023
Study completion11 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Hemiplegia And/or Hemiparesis Following StrokeStudies 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: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04268641
Sponsor's protocol ID: GHIV0417
Acronym: POSIT-HEMI
Status last verified: Jan 2024
First submitted: 10 Feb 2020
Last updated: 19 Sep 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
High-Intensity Laser Therapy in Hemiplegic Shoulder Pain
Hemiplegia and/or Hemiparesis Following Stroke
Active, not recruiting
The Effect of Good Limb Position Management Assistive Devices on Preventing Shoulder Subluxation in Hemiplegic Patients
Hemiplegia and/or Hemiparesis Following Stroke
Not yet recruiting
Immediate Effects of PETTLEP-Based AOMI on Upper Limb Kinematics in Stroke Survivors
Stroke, Hemiplegia
Recruiting
Effect of Transcutaneous Electrical Nerve Stimulation on Post-stroke Patients
Hemiplegia and/or Hemiparesis Following Stroke, Anterior Circulation Stroke of Uncertain Pathology
RecruitingPhase 1
Psychedelic Healing: Adjunct Therapy Harnessing Opened Malleability
Stroke, Chronic Stroke

All Hemiplegia And/or Hemiparesis Following Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Positioning Protocols with an Adapted Equipment on a Wheelchair in Hemiplegic Patients Following a Stroke
ClinicalTrials.gov ID: NCT04268641
Acronym / sponsor ID: POSIT-HEMI / GHIV0417
Conditions: Hemiplegia And/or Hemiparesis Following Stroke
Keywords: Hemiplegia, Stroke, Wheelchair positioning, Propulsion, Pelvic posterior tilt, Obliquity
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Hôpital NOVOUniversity, hospital or other
Study start: 28 Aug 2020 (actual)
Primary completion: 11 Dec 2023 (actual)
Study completion: 11 Dec 2023 (actual)
First posted: 13 Feb 2020 (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 main purpose of this study is to assess the interest of using wheelchair positioning equipment on the decrease of postural disorders, compared to the standard use of a wheelchair

Detailed description

This study aims to assess the interest of using wheelchair positioning equipment (Seat back, Positioning cushion and Belt) on the decrease of postural disorders.

Clinical tool used to assess the decrease is the Seated Postural Control Measure for Adults 2.0 (SPCMA 2.0).

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Use of positioning equipment order 1	Experimental	Other: Arm 1One standardized course is performed 3 times by each patient : one with a standard wheelchair and the 2 other with one or two positioning equipment (Seat back or/and positioning cushion) Each arm differs from the previous by the order of use of the equipment.
Use of positioning equipment order 2	Experimental	Other: Arm 2One standardized course is performed 3 times by each patient : one with a standard wheelchair and the 2 other with one or two positioning equipment (Seat back or/and positioning cushion) Each arm differs from the previous by the order of use of the equipment.
Use of positioning equipment order 3	Experimental	Other: Arm 3One standardized course is performed 3 times by each patient : one with a standard wheelchair and the 2 other with one or two positioning equipment (Seat back or/and positioning cushion) Each arm differs from the previous by the order of use of the equipment.
Use of positioning equipment order 4	Experimental	Other: Arm 4One standardized course is performed 3 times by each patient : one with a standard wheelchair and the 2 other with one or two positioning equipment (Seat back or/and positioning cushion) Each arm differs from the previous by the order of use of the equipment.
Use of positioning equipment order 5	Experimental	Other: Arm 5One standardized course is performed 3 times by each patient : one with a standard wheelchair and the 2 other with one or two positioning equipment (Seat back or/and positioning cushion) Each arm differs from the previous by the order of use of the equipment.
Use of positioning equipment order 6	Experimental	Other: Arm 6One standardized course is performed 3 times by each patient : one with a standard wheelchair and the 2 other with one or two positioning equipment (Seat back or/and positioning cushion) Each arm differs from the previous by the order of use of the equipment.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Hemiplegic patient following a stroke
Hospitalized in a follow-up and rehabilitative care service, after hospital stays in a MCO service (neurology, neurosurgery or reanimation)
With a planned exit from hospital (homecoming, residential care facilities, nursing home, Long Term Care Unit …)
Patient whose wheelchair choice should be already done
Patient who propels the wheelchair with the valid hand and/or valid foot

Key exclusion criteria (5 listed)

Good walk recovery (FAC scale >3)
Wheelchair with a double hand rim
Patient who cannot use his2 wheelchair independently
Cognitive disorders which prevent the ability to well understanding the instructions
Other pathology which can interfere with this protocol (Spinal disorder, morbid overweight (BMI>40…)

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
Arm 1Materials used for the course : 1. : Standard Wheelchair 2. : Standard Wheelchair + Seat back + Positioning cushion 3. : Standard Wheelchair + Seat back + Positioning cushion + Belt	Other	Use of positioning equipment order 1
Arm 2Materials used for the course : 1. : Standard Wheelchair 2. : Standard Wheelchair + Seat back + Positioning cushion + Belt 3. : Standard Wheelchair + Seat back + Positioning cushion	Other	Use of positioning equipment order 2
Arm 3Materials used for the course : 1. : Standard Wheelchair + Seat back + Positioning cushion 2. : Standard Wheelchair + Seat back + Positioning cushion + Belt 3. : Standard Wheelchair	Other	Use of positioning equipment order 3
Arm 4Materials used for the course : 1. : Standard Wheelchair + Seat back + Positioning cushion 2. : Standard Wheelchair 3. : Standard Wheelchair + Seat back + Positioning cushion + Belt	Other	Use of positioning equipment order 4
Arm 5Materials used for the course : 1. : Standard Wheelchair + Seat back + Positioning cushion + Belt 2. : Standard Wheelchair 3. : Standard Wheelchair + Seat back + Positioning cushion	Other	Use of positioning equipment order 5
Arm 6Materials used for the course : 1. : Standard Wheelchair + Seat back + Positioning cushion + Belt 2. : Standard Wheelchair + Seat back + Positioning cushion 3. : Standard Wheelchair	Other	Use of positioning equipment order 6

Primary outcome

Degree of pelvic posterior tilt
Time frame: Immediately after the end of the procedure, an average of 1 day
The Primary Outcome Measure is the variation of the Degree of pelvic posterior tilt at the end of the three standardized course. These courses were performed with Standard Wheelchair, Standard Wheelchair + Seat back + Positioning cushion + Belt or with Standard Wheelchair + Seat back + Positioning cushion. The Degree of pelvic posterior tilt was measured using the SPCMA 2.0 score (0 = normal, 1 = mild, 2 = moderate and 3 = severe retroversion)

8 secondary outcomes

Variation of Degree of pelvic posterior tilt
Time frame: Baseline and immediately after the end of the procedure, an average of 1 day
Variation of degree of lateral inclination of the torso
Time frame: Baseline and immediately after the end of the procedure, an average of 1 day
Variation of the degree of Pelvis obliquity
Time frame: Baseline and immediately after the end of the procedure, an average of 1 day
Degree of lateral inclination of the torso
Time frame: Immediately after the end of the procedure, an average of 1 day
Degree of Pelvis obliquity
Time frame: Immediately after the end of the procedure, an average of 1 day
Measure of patient's satisfaction
Time frame: Immediately after the end of the procedure, an average of 1 day
Ability to achieve the whole course
Time frame: Immediately after the end of the procedure, an average of 1 day
Adverse event collect
Time frame: Immediately after the end of the procedure, an average of 1 day

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 19 Sep 2024.
Individual participant dataSharing planned: No

Related trials for Hemiplegia And/or Hemiparesis Following Stroke

Recruiting
High-Intensity Laser Therapy in Hemiplegic Shoulder Pain
Hemiplegia and/or Hemiparesis Following Stroke
Active, not recruiting
The Effect of Good Limb Position Management Assistive Devices on Preventing Shoulder Subluxation in Hemiplegic Patients
Hemiplegia and/or Hemiparesis Following Stroke
Not yet recruiting
Immediate Effects of PETTLEP-Based AOMI on Upper Limb Kinematics in Stroke Survivors
Stroke, Hemiplegia
Recruiting
Effect of Transcutaneous Electrical Nerve Stimulation on Post-stroke Patients
Hemiplegia and/or Hemiparesis Following Stroke, Anterior Circulation Stroke of Uncertain Pathology
RecruitingPhase 1
Psychedelic Healing: Adjunct Therapy Harnessing Opened Malleability
Stroke, Chronic Stroke

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 Pellegrini principal investigator

Groupement Hospitalier Intercommunal du Vexin

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Arm 1, Arm 2 and Arm 3 in people with Hemiplegia And/or Hemiparesis Following Stroke, run by Hôpital NOVO at 7 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 7 inclusion and 5 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 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?

Degree of pelvic posterior tilt (time frame: Immediately after the end of the procedure, an average of 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04268641.

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 19 Sep 2024.