NCT02085954

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

October 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 13, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

March 2, 2016

Status Verified

October 1, 2015

Enrollment Period

2.2 years

First QC Date

January 28, 2014

Last Update Submit

March 1, 2016

Conditions

GaitStrokeRobotic Rehabilitation

Outcome Measures

Primary Outcomes (1)

  • peak knee flexion (degrees)

    participants will be followed for the duration of hospital stay, an expected average of 1 week

Secondary Outcomes (3)

  • 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

  • spatio temporal parameter (m/s)

    participants will be followed for the duration of hospital stay, an expected average of 1 week

Eligibility Criteria

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

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

You may qualify if:

  • single stroke
  • able to walk alone
  • \> 18years

You may not qualify if:

  • Cognitive impairments disturbing understanding
  • Uncontrolled medical disorder associated

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Raymond Poincare

Garches, Garches, 92380, France

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 28, 2014

First Posted

March 13, 2014

Study Start

October 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

March 2, 2016

Record last verified: 2015-10

Locations

FR(1)