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Effects of a Positive Slope Treadmill Training in Individuals After Stroke. (Hemislope) (Hemislope)

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Inclined treadmill training
Sponsored by
Centre d'Investigation Clinique et Technologique 805
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Hopital Raymond Poincare

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

hemiplegic patient

Arm Description

Outcomes

Primary Outcome Measures

kinematic gait parameters
angles quantification of lower limbs joints
cinetic gait parameters
moments and joints power quantification in the lower limb

Secondary Outcome Measures

Full Information

First Posted
December 24, 2014
Last Updated
March 21, 2017
Sponsor
Centre d'Investigation Clinique et Technologique 805
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1. Study Identification

Unique Protocol Identification Number
NCT02333032
Brief Title
Effects of a Positive Slope Treadmill Training in Individuals After Stroke. (Hemislope)
Acronym
Hemislope
Official Title
Evaluation of Biomechanical and Functional Effects of a Positive Slope Treadmill Training in Individuals After Stroke.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre d'Investigation Clinique et Technologique 805

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
comparison between patients having a single session of treadmill training with slope and those having a single session of treadmill training with no slope

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
randomised controlled study experimental group : training with slope N=15 control group training with no slope N=15
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
hemiplegic patient
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Inclined treadmill training
Primary Outcome Measure Information:
Title
kinematic gait parameters
Description
angles quantification of lower limbs joints
Time Frame
One year
Title
cinetic gait parameters
Description
moments and joints power quantification in the lower limb
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Hemiplegic patient capacity to walk during 20 minutes without technical assistance Exclusion Criteria: patient with bilateral brain lesions previous orthopedic surgery pregnant woman
Facility Information:
Facility Name
Hopital Raymond Poincare
City
Garches
ZIP/Postal Code
92380
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effects of a Positive Slope Treadmill Training in Individuals After Stroke. (Hemislope)

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