NCT02333032

Brief Summary

The main objective of this study is to determine if a single session of treadmill training with a positive slope improves the kinematic parameters of the hip, knee and ankle on the paretic lower limb. Secondarily we will quantify the efficiency of a such training on kinetic and functional parameters.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Feb 2015

Shorter than P25 for not_applicable stroke

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

First Submitted

Initial submission to the registry

December 24, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 7, 2015

Completed
25 days until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

March 22, 2017

Status Verified

March 1, 2017

Enrollment Period

2 months

First QC Date

December 24, 2014

Last Update Submit

March 21, 2017

Conditions

Stroke

Outcome Measures

Primary Outcomes (2)

  • kinematic gait parameters

    angles quantification of lower limbs joints

    One year

  • cinetic gait parameters

    moments and joints power quantification in the lower limb

    one year

Study Arms (1)

hemiplegic patient

EXPERIMENTAL
Other: Inclined treadmill training

Interventions

Inclined treadmill trainingOTHER
hemiplegic patient

Eligibility Criteria

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

You may qualify if:

  • Hemiplegic patient
  • capacity to walk during 20 minutes without technical assistance

You may not qualify if:

  • patient with bilateral brain lesions
  • previous orthopedic surgery
  • pregnant woman

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
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: randomised controlled study experimental group : training with slope N=15 control group training with no slope N=15
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 24, 2014

First Posted

January 7, 2015

Study Start

February 1, 2015

Primary Completion

April 1, 2015

Study Completion

July 1, 2015

Last Updated

March 22, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)