Post-strokeHEMITENNISNCT05857072
Evaluation of the Mechanisms of Weight-bearing of the Hemiplegic Limb During Table Tennis Sessions in the Framework of Post-stroke Rehabilitation : Pilot Study
An observational study of Post-stroke and Hemiplegic Gait, run by FondationbHopale at 1 site in France.
Trial summary
This is an experimental, observational, prospective study designed to develop medical knowledge. The primary objective of the study is to analyze the weight bearing of the hemiplegic side according to the different areas of interest during the practice of table tennis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-stroke, Hemiplegic Gait, Rehabilitation
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 3 May 2023to Oct 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients will be recruited among the patients included in the "balance and coordination" rehabilitation protocol at the Jacques Calvé center of the Hopale Foundation.
Who may be able to join
- Patients treated at the Hopale Foundation for a stroke rehabilitation program
- Patients following the balance and coordination protocol - Minimum age of 18 years
- BERG score >40
- Subject has played table tennis at least once prior to the stroke.
- Patient is a member or beneficiary of a social security plan.
- Patient who has received informed information about the study and has given his/her consent
- Ability to understand French instructions.
Who cannot join
- Cognitive disorders notified in the medical file
- Subject under judicial protection :
- Subject under guardianship
- Subject under curatorship
- Subject under protective measure
- Pregnant or breastfeeding woman
- Patient with cognitive disorders preventing the comprehension of instructions
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Institut Calvé
Berck
Marine Deseur, 03 62 88 27 80
About this study
This is an experimental, observational, prospective study designed to develop medical knowledge.
The primary objective of the study is to analyze the weight bearing of the hemiplegic side according to the different areas of interest during the practice of table tennis.
Read more
This study is part of a usual framework of management of post-stroke hemiplegic patients with an additional passage to the movement laboratory to collect additional data collection, via the use of force plateforms, considered here as non-interventional.
The passage to the movement laboratory consists in the practice of a table tennis session including three game situations. Before to the table tennis session, the subject placed on the force plateforms, performs a spontaneous bipodal station followed by a maximum voluntary support transfer on the hemiplegic limb. During the table tennis session, the subject is filmed and his load on the hemiplegic side during the game situations is evaluated using the force platforms.
In addition of the table tennis session three questionnaires are administered to the patient in order to know :
- The static and dynamic balance in order to identify persons at risk of falling: Berg Balance and Evaluation Scale
- The degree of autonomy of the patient: Modified Rankin Score
- The Stroke severity: NIHSS score
- Conditions
- Post-stroke, Hemiplegic Gait, Rehabilitation
- Medical subject headings
- Gait Disorders, Neurologic
What is being measured
The primary outcome is the main question the study is designed to answer.
To analyze the weight bearing on the hemiplegic side according to the different areas of interest of interest during the practice of table tennis.
The vertical force peaks (Fz) under the hemiplegic foot and under the non-injured foot recorded during the subject's ball returns throughout the session. These peaks will be categorized according to the zones and the shots used by the subject.
Measured: During the only table tennis session on the one day of patient inclusion
Secondary outcomes (1)
To compare the weight bearing on the hemiplegic side during table tennis practice to a voluntary weight-bearing exercise on the injured limb.
Peak vertical force (Fz) under the hemiplegic foot and under the non-injured foot are compared between table tennis and the analytical exercise of voluntary weight-bearing voluntary.
Measured: During the only table tennis session on the one day of patient inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2023
- Study start3 May 2023
- Primary completionOct 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FondationbHopale
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie PERSINE, Principal investigator, Centre Calvé, Fondation Hopale
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05857072
- Sponsor's protocol ID
- HOP22-RIPH3-08
- Acronym
- HEMITENNIS
- Status last verified
- May 2023
- First submitted
- 27 Apr 2023
- Last updated
- 12 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Mechanisms of Weight-bearing of the Hemiplegic Limb During Table Tennis Sessions in the Framework of Post-stroke Rehabilitation : Pilot Study
- ClinicalTrials.gov ID
- NCT05857072
- Acronym / sponsor ID
- HEMITENNIS / HOP22-RIPH3-08
- Conditions
- Post-stroke, Hemiplegic Gait, Rehabilitation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- FondationbHopaleUniversity, hospital or other
- Study start
- 3 May 2023 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 12 May 2023 (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 an experimental, observational, prospective study designed to develop medical knowledge.
The primary objective of the study is to analyze the weight bearing of the hemiplegic side according to the different areas of interest during the practice of table tennis.
This study is part of a usual framework of management of post-stroke hemiplegic patients with an additional passage to the movement laboratory to collect additional data collection, via the use of force plateforms, considered here as non-interventional.
The passage to the movement laboratory consists in the practice of a table tennis session including three game situations. Before to the table tennis session, the subject placed on the force plateforms, performs a spontaneous bipodal station followed by a maximum voluntary support transfer on the hemiplegic limb. During the table tennis session, the subject is filmed and his load on the hemiplegic side during the game situations is evaluated using the force platforms.
In addition of the table tennis session three questionnaires are administered to the patient in order to know :
- The static and dynamic balance in order to identify persons at risk of falling: Berg Balance and Evaluation Scale
- The degree of autonomy of the patient: Modified Rankin Score
- The Stroke severity: NIHSS score
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients will be recruited among the patients included in the "balance and coordination" rehabilitation protocol at the Jacques Calvé center of the Hopale Foundation.
Key inclusion criteria (7 listed)
- Patients treated at the Hopale Foundation for a stroke rehabilitation program
- Patients following the balance and coordination protocol - Minimum age of 18 years
- BERG score >40
- Subject has played table tennis at least once prior to the stroke.
- Patient is a member or beneficiary of a social security plan.
Key exclusion criteria (7 listed)
- Cognitive disorders notified in the medical file
- Subject under judicial protection :
- Pregnant or breastfeeding woman
- Patient with cognitive disorders preventing the comprehension of instructions
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
To analyze the weight bearing on the hemiplegic side according to the different areas of interest of interest during the practice of table tennis.
Time frame: During the only table tennis session on the one day of patient inclusion
The vertical force peaks (Fz) under the hemiplegic foot and under the non-injured foot recorded during the subject's ball returns throughout the session. These peaks will be categorized according to the zones and the shots used by the subject.
1 secondary outcome
To compare the weight bearing on the hemiplegic side during table tennis practice to a voluntary weight-bearing exercise on the injured limb.
Time frame: During the only table tennis session on the one day of patient inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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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.
Sophie PERSINE principal investigator
Centre Calvé, Fondation Hopale
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 Post-stroke and Hemiplegic Gait, run by FondationbHopale 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 7 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 12 May 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marine DESEUR (0362882780, marine.deseur@fondation-hopale.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To analyze the weight bearing on the hemiplegic side according to the different areas of interest of interest during the practice of table tennis. (time frame: During the only table tennis session on the one day of patient inclusion). 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 12 May 2023.