NCT05857072

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

May 3, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 12, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

May 12, 2023

Status Verified

May 1, 2023

Enrollment Period

5 months

First QC Date

April 27, 2023

Last Update Submit

May 10, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 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.

    During the only table tennis session on the one day of patient inclusion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Calvé

Berck, France

RECRUITING

Related Links

MeSH Terms

Conditions

Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sophie PERSINE

    Centre Calvé, Fondation Hopale

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2023

First Posted

May 12, 2023

Study Start

May 3, 2023

Primary Completion

October 1, 2023

Study Completion

October 1, 2023

Last Updated

May 12, 2023

Record last verified: 2023-05

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