Evaluation of the Mechanisms of Weight-bearing of the Hemiplegic Limb During Table Tennis Sessions in the Framework of Post-stroke Rehabilitation : Pilot Study (HEMITENNIS)

May 10, 2023 updated by: FondationbHopale

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 Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Berck, France
        • Recruiting
        • Institut Calvé
        • Contact:
          • Marine Deseur
          • Phone Number: 03 62 88 27 80

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During the only table tennis session on the one day of patient inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

FondationbHopale

Investigators

  • Principal Investigator: Sophie PERSINE, Centre Calvé, Fondation Hopale

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 3, 2023

Primary Completion (Anticipated)

October 1, 2023

Study Completion (Anticipated)

October 1, 2023

Study Registration Dates

First Submitted

April 27, 2023

First Submitted That Met QC Criteria

May 10, 2023

First Posted (Actual)

May 12, 2023

Study Record Updates

Last Update Posted (Actual)

May 12, 2023

Last Update Submitted That Met QC Criteria

May 10, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HOP22-RIPH3-08

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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