Time Up and go in Hemiplegic Patients | NCT01807273

Studies
Time Up and go in Hemiplegic Patients

NCT01807273

Sponsor

Centre d'Investigation Clinique et Technologique 805

Status

Completed

Last Update Posted

Feb 4, 2015Estimated

Enrollment

60Actual

Phase

Not provided

Conditions

Difficulty Walking

Interventions

Walking test

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2013

Primary Completion Date

Mar 2013Actual

Completion Date

Nov 2014Actual

First Submitted Date

Mar 7, 2013

First Submission Date that Met QC Criteria

Mar 7, 2013

First Posted Date

Mar 8, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 3, 2015

Last Update Posted Date

Feb 4, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Nicolas ROCHE, MDPHD, Centre d'Investigation Clinique et Technologique 805Principal Investigator

Lead Sponsor

Centre d'Investigation Clinique et Technologique 805OTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Investing the Timed Up and Go (TUG) Test in Hemiplegic Patients Using 3D Motion Analysis

Detailed Description

The timed up and go is a routine quick test assessing motor functional tasks including stand up ,walk 3 m,turn around and sitting down.We will included hemiplegic patients to quantify biomechanic parameters

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hemiplegic subjects		60 hemiplegic outpatients walking test	Other: Walking test

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Walking test	Other		Hemiplegic subjects	The TUG test included stand up ,walk,turn around ,sit down

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Variability of the center of mass	subjects will perform the TUG test with 3D walk analysis equipment	1 hour

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients performing 3D gait analysis
Male or female adults aged ≥ 18 years,
Hemiplegia following unique stroke- Patients with hemiplegia able to stand up alone,walk and turn around alone without assistance.

Exclusion Criteria:

Patient with a protective measure,
Pregnant women, breastfeeding
Brain damage bilateral cerebellar syndrome, apraxia and / or severe aphasia,
Patient who received botulinum toxin injection in the 3 months prior to inclusion, patients who underwent surgery of the locomotor system in the 6 months prior to inclusion,
No affiliation to a social security
other pathology, complications with significant impact on the activities of walking.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

60 hemiplegic out patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nicolas ROCHE, MDPHD	HOPITAL RAYMOND POINCARE	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hopital Raymond Poincare		Garches	Garches	92380	France

Condition Browse Module

MeSH Terms

ID	Term
D051346	Mobility Limitation

Ancestor Terms

ID	Term
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided