NCT02971774

Brief Summary

The aim of the study consists in enriching knowledge of health professionals, on the functional difficulties encountered by hemiplegic patients outside the hospital, in particular on hobbies, going out with friends or family, work, daily life and the personal projects. Another objective is to evaluate the diversity of the attitudes and representations of the patients about their body damage. Lastly, the study seeks to develop a new grid of evaluation of the quality of life of the patients, which determines more fields of the existence significantly impacted by the hemiparesy, from the point of view of the patients. It is a question of improving the therapeutic care of the patients and to determine if various therapeutic approaches (occupational, pharmacological, surgical) have an impact on these various fields. The study will be based on qualitative data (interviews) and quantitative (questionnaires).

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
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2017

Typical duration 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

November 21, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 23, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

July 24, 2019

Status Verified

July 1, 2018

Enrollment Period

2.7 years

First QC Date

November 21, 2016

Last Update Submit

July 22, 2019

Conditions

Keywords

strokebotulinum toxin injectiondaily life

Outcome Measures

Primary Outcomes (1)

  • daily life questionnary

    45 minutes

Study Arms (1)

questionnary

self administered questionnary

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study will target adults regularly followed in the department of physical medicine and rehabilitation of the Raymond-Poincaré hospital. These individuals must present with hemiparesis secondary to a single, hemispheric cerebrovascular accident, be living at home and be able to move inside and outside of the home.

You may qualify if:

  • Patient older than 18 years old
  • patient with hemiparesis secondary to a single hemispheric cerebrovascular accident
  • be living at home
  • be able to move inside and outside of the home

You may not qualify if:

  • Patients having several severe cognitive disorders
  • Patients having severe aphasia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Raymond Poincaré Hospital

Garches, 92380, France

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Nicolas ROCHE, MD PhD

    Raymond Poincare Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicolas ROCHE, MD PhD

CONTACT

Study Design

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

Study Record Dates

First Submitted

November 21, 2016

First Posted

November 23, 2016

Study Start

January 1, 2017

Primary Completion

October 1, 2019

Study Completion

December 1, 2019

Last Updated

July 24, 2019

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations