Evaluation of a Training in the Walking With Exosquelette | NCT02085954

Studies
Evaluation of a Training in the Walking With Exosquelette

NCT02085954

Sponsor

Centre d'Investigation Clinique et Technologique 805

Status

Completed

Last Update Posted

Mar 2, 2016Estimated

Enrollment

13Actual

Phase

Not provided

Conditions

Gait
Stroke
Robotic Rehabilitation

Interventions

Not provided

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

Oct 2015

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

Oct 2013

Primary Completion Date

Dec 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

Jan 28, 2014

First Submission Date that Met QC Criteria

Mar 11, 2014

First Posted Date

Mar 13, 2014Estimated

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

Mar 1, 2016

Last Update Posted Date

Mar 2, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Nicolas ROCHE, MD, 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

Stroke patients in the investigators rehabilitation unit follow gait trainings with robotic-assistive devices such as Lokomat. Patients able to walk alone are also assessed with 3D gait analysis. The objective of this study is to assess the effects of gait training in Lokomat on biomecanic gait parameters in stroke patients.

Detailed Description

Not provided

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

13Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
peak knee flexion (degrees)		participants will be followed for the duration of hospital stay, an expected average of 1 week

Secondary Outcomes

Measure	Description	Time Frame
hip and ankle kinematics (degrees)		participants will be followed for the duration of hospital stay, an expected average of 1 week
kinetics (newton/meter)		participants will be followed for the duration of hospital stay, an expected average of 1 week

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

single stroke
able to walk alone
> 18years

Exclusion Criteria:

Cognitive impairments disturbing understanding
Uncontrolled medical disorder associated

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

stroke patients follow in our rehabilitation hospital, able to walk alone

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

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

Condition Browse Module

MeSH Terms

ID	Term
D020521	Stroke

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided