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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05857072
Other study ID # HOP22-RIPH3-08
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 3, 2023
Est. completion date October 2023

Study information

Verified date May 2023
Source FondationbHopale
Contact Marine DESEUR
Phone 0362882780
Email marine.deseur@fondation-hopale.org
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date October 2023
Est. primary completion date October 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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

Study Design


Locations

Country Name City State
France Institut Calvé Berck

Sponsors (1)

Lead Sponsor Collaborator
FondationbHopale

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. During the only table tennis session on the one day of patient inclusion
Secondary 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. During the only table tennis session on the one day of patient inclusion
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