HemiparesisHemiSymNCT07082036
Stability of Hemiparetic Patients During a Daily Complex Task
An observational study of Hemiparesis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Among the repercussions of hemiparesis following stroke, disturbed stability is responsible for a high risk of falls. Picking up objects from the ground, frequently trained in rehabilitation due to its risk of falling and its frequency in daily life, is a task requiring balance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemiparesis
- How many people
- 72 participants
- Where
- 1 siteFrance
- Study dates
- 5 Nov 2024to Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Hemiparetic patients following stroke; Healthy subjects (same age, height, weight).
Who may be able to join
- All:
- Male or female ≥ 18 years
- For patients :
- Haemiparesis after a single unilateral hemispheric Stroke.
- Stroke ≥ 6 months
- Asymmetry of support between the 2 lower limbs (distribution of body weight) in a standing position at the expense of the paretic lower limb > 10%.
Show all 11Show fewer
- Able to stand alone, without technical aids or equipment, with feet the width of the pelvis
- Able to pick up an object from the ground alone (minimum score 3/4 item 9 of the Berg Balance Scale).
- Patient informed and having signed a consent form
- For healthy subjects:
- Similar characteristics (in terms of sex, age range and BMI class) to those of one of the patients already included.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Raymond Poincaré - APHP
Garches, 92380
About this study
Official title: Study of the Stability of Post-stroke Hemiparetic Patients During a Task Involving Picking up an Object on the Ground. Reflection Questioning the Conventional Rehabilitation of These Patients
Among the repercussions of hemiparesis following stroke, disturbed stability is responsible for a high risk of falls. Picking up objects from the ground, frequently trained in rehabilitation due to its risk of falling and its frequency in daily life, is a task requiring balance. To date, however, it has been little studied. We suggest that stability conditions the asymmetry adopted by patients. We hypothesise that asymmetric support at the expense of the paretic lower limb provides better stability during an unstable functional task (picking up an object from the ground) compared with the symmetrical support traditionally imposed in rehabilitation.
Postural control involves stability (maintaining balance despite constraints) and orientation (posture adopted, such as the distribution of supports). Hemiparetic patients show a lack of stability and, with regard to orientation, an asymmetry in the distribution of body weight to the detriment of the paretic limb. Symmetrisation of weight distribution has been one of the predominant concepts in rehabilitation.
Read the detailed description
To analyse the stability of hemiparetic stroke patients when picking up an object on the ground in a spontaneous condition compared with a condition of imposed support symmetry.
To analyse and compare the stability, spontaneous symmetry and duration of picking up the object in a complex situation (distant target) compared with the near target in stroke patients and healthy subjects.
To explore strategy and performance of picking up the object regarding clinical outcomes (falls, sensori-motor impairments, balance..) To compare strategy of patients with right and left stroke.
- Conditions
- Hemiparesis
- Keywords
- Hemiparetic patients, Stability, Orientation, Postural control, Strategy, Motion
- Medical subject headings
- Paresis, Orientation, Spatial
What is being measured
The primary outcome is the main question the study is designed to answer.
stability parameter: the range of the medio-lateral centre of pressure during the object picking up task
Two forceplate platforms. 3 trials for each condition
Measured: at baseline
Secondary outcomes (14)
Velocity of the centre of pressure
Mean velocity and in each place, in mm/s, obtained with forceplat plateforms under feet of participants during the object picking up task.
Measured: at baseline
Ellipse area of the centre of pressure
With 95% confidence, in mm², obtained with forceplat plateforms under feet of participants during the object picking up task
Measured: at baseline
Range of the centre of pressure
Range in antero-posterior plane, in mm, obtained with forceplat plateforms during the object picking up task
Measured: at baseline
Percentage of weight bearing
Under each lower limb, in %, obtained with forceplat plateforms during the object picking up task
Measured: at baseline
Kinematics parameters
range of movements of trunk, pelvis and lower limbs (hip, knee, ankle), in degrees, obtained with the optoelectronic system during the object picking up task
Measured: at baseline
Questionnaires : Confidence perception and stability perception during the object picking up task
On a visual scale 0 (no confidence) to 10 (perfect confidence)
Measured: at baseline
Clinical scales - Berg balance scale
Measured: at baseline
Clinical scales-Medical Research Council
Measured: at baseline
Clinical scales-Modified Ashworth
Measured: at baseline
Clinical scales-Nottingham Sensory Assessment
Measured: at baseline
Clinical scales -Neglect and lateropulsion scale
Measured: at baseline
Cognitive scale : Batterie Rapide d'Efficience Frontale
Measured: at baseline
Activities-Specific Balance Confidence
Measured: at baseline
Functional reach test
In cm
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start5 Nov 2024
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemiparesisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Céline Bonnyaud, Principal investigator, Motion Analysis Laboratory, CHU Raymond Poincaré - APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07082036
- Sponsor's protocol ID
- APHP230812
- Other IDs
- 2024-A00043-44
- Acronym
- HemiSym
- Status last verified
- Jul 2025
- First submitted
- 21 May 2025
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Stability of Post-stroke Hemiparetic Patients During a Task Involving Picking up an Object on the Ground. Reflection Questioning the Conventional Rehabilitation of These Patients
- ClinicalTrials.gov ID
- NCT07082036
- Acronym / sponsor ID
- HemiSym / APHP230812
- Conditions
- Hemiparesis
- Keywords
- Hemiparetic patients, Stability, Orientation, Postural control, Strategy, Motion
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 5 Nov 2024 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 24 Jul 2025 (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.
Among the repercussions of hemiparesis following stroke, disturbed stability is responsible for a high risk of falls. Picking up objects from the ground, frequently trained in rehabilitation due to its risk of falling and its frequency in daily life, is a task requiring balance. To date, however, it has been little studied. We suggest that stability conditions the asymmetry adopted by patients. We hypothesise that asymmetric support at the expense of the paretic lower limb provides better stability during an unstable functional task (picking up an object from the ground) compared with the symmetrical support traditionally imposed in rehabilitation.
Postural control involves stability (maintaining balance despite constraints) and orientation (posture adopted, such as the distribution of supports). Hemiparetic patients show a lack of stability and, with regard to orientation, an asymmetry in the distribution of body weight to the detriment of the paretic limb. Symmetrisation of weight distribution has been one of the predominant concepts in rehabilitation.
Detailed description
To analyse the stability of hemiparetic stroke patients when picking up an object on the ground in a spontaneous condition compared with a condition of imposed support symmetry.
To analyse and compare the stability, spontaneous symmetry and duration of picking up the object in a complex situation (distant target) compared with the near target in stroke patients and healthy subjects.
To explore strategy and performance of picking up the object regarding clinical outcomes (falls, sensori-motor impairments, balance..) To compare strategy of patients with right and left stroke.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hemiparetic patients following stroke; Healthy subjects (same age, height, weight).
Key inclusion criteria (11 listed)
- Male or female ≥ 18 years
- Haemiparesis after a single unilateral hemispheric Stroke.
- Stroke ≥ 6 months
- Asymmetry of support between the 2 lower limbs (distribution of body weight) in a standing position at the expense of the paretic lower limb > 10%.
- Able to stand alone, without technical aids or equipment, with feet the width of the pelvis
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
stability parameter: the range of the medio-lateral centre of pressure during the object picking up task
Time frame: at baseline
Two forceplate platforms. 3 trials for each condition
14 secondary outcomes
Velocity of the centre of pressure
Time frame: at baseline
Ellipse area of the centre of pressure
Time frame: at baseline
Range of the centre of pressure
Time frame: at baseline
Percentage of weight bearing
Time frame: at baseline
Kinematics parameters
Time frame: at baseline
Questionnaires : Confidence perception and stability perception during the object picking up task
Time frame: at baseline
Clinical scales - Berg balance scale
Time frame: at baseline
Clinical scales-Medical Research Council
Time frame: at baseline
Clinical scales-Modified Ashworth
Time frame: at baseline
Clinical scales-Nottingham Sensory Assessment
Time frame: at baseline
Clinical scales -Neglect and lateropulsion scale
Time frame: at baseline
Cognitive scale : Batterie Rapide d'Efficience Frontale
Time frame: at baseline
Activities-Specific Balance Confidence
Time frame: at baseline
Functional reach test
Time frame: at baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Hemiparesis
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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.
Céline Bonnyaud principal investigator
Motion Analysis Laboratory, CHU Raymond Poincaré - APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemiparesis, run by Assistance Publique - Hôpitaux de Paris at 1 site 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 1 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: looking for participants now, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Céline Bonnyaud, PhD (+ 33 01 71 14 49 21, celine.bonnyaud@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
stability parameter: the range of the medio-lateral centre of pressure during the object picking up task (time frame: at baseline). 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 24 Jul 2025.