Back to resultsWalking Training With Partial Body Weight Support on Static and Dynamic Surfaces in Stroke Survivers
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Static surface
Dynamic surface
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Rehabilitation, Gait, Stroke, Biomechanics
Eligibility Criteria
Inclusion Criteria:
- One-sided hemiparesis, No heart disease (or medical clearance to participate in the study), No orthopedic impairments and / or neurological symptoms that may alter the the gait, no history of thrombophlebitis or deep vein thrombosis, Ability to understand and follow verbal commands, Can walk alone or with canes of approximately 10 m; Spasticity degree mild to moderate in the affected lower limb with levels of classification between 0 and 2 in the Ashworth spasticity scale modified
Exclusion Criteria:
- Heart frequency increase more than 75% of the maximum or have any other general instability during training that may lead risk for the health during the training,
Sites / Locations
- Cruzeiro do Sul University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Static surface
dynamic surface
Arm Description
The subjects will do the walking training with partial body weight support on static surface. The will be submitted to three weekly training sessions of approximately 45 minutes each , for six weeks , totaling 18 sessions
The subjects will do the walking training with partial body weight support on dynamic surface. The will be submitted to three weekly training sessions of approximately 45 minutes each , for six weeks , totaling 18 sessions
Outcomes
Primary Outcome Measures
Change from Baseline in the gait velocity
Speed at which subjects walked measured by the 10 meters test
Secondary Outcome Measures
Distribution of body weight
Body weight Distribution measured while subjects are in a static position on two force platforms.
Functional independence
a score was assigned for each everyday activity, according to the amount of assistance required to perform it. Measured by a clinical scale (Functional Independence Measure Scale.
Lower limb recovery
Measured by a clinical scale (Fulgy Meyer).
Endurance
Measured by the 6 minutes walking test
Full Information
NCT ID
NCT02088255
First Posted
March 10, 2014
Last Updated
March 7, 2016
Sponsor
Universidade Cruzeiro do Sul
1. Study Identification
Unique Protocol Identification Number
NCT02088255
Brief Title
Walking Training With Partial Body Weight Support on Static and Dynamic Surfaces in Stroke Survivers
Official Title
Walking Training With Partial Body Weight Support on Static and Dynamic Surfaces in Individuals With Hemiparesis Due to Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Cruzeiro do Sul
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is evaluate the effects of walking training with partial body weight support on static (floor) and dynamic (treadmill) surfaces in individuals with hemiparesis due to stroke. For this purpose, two training protocols will be employed in three experimental groups: G1 will do the walking training with partial body weight support on static surfaces and G2 will do the walking training with partial body weight support on dynamic surfaces
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Rehabilitation, Gait, Stroke, Biomechanics
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Static surface
Arm Type
Active Comparator
Arm Description
The subjects will do the walking training with partial body weight support on static surface. The will be submitted to three weekly training sessions of approximately 45 minutes each , for six weeks , totaling 18 sessions
Arm Title
dynamic surface
Arm Type
Active Comparator
Arm Description
The subjects will do the walking training with partial body weight support on dynamic surface. The will be submitted to three weekly training sessions of approximately 45 minutes each , for six weeks , totaling 18 sessions
Intervention Type
Procedure
Intervention Name(s)
Static surface
Other Intervention Name(s)
floor walking training
Intervention Description
During all session time the subject will walk on the floor with partial body weight support. This protocol will be repeated in all sessions.
Intervention Type
Procedure
Intervention Name(s)
Dynamic surface
Other Intervention Name(s)
Treadmill Training
Intervention Description
During all session time the subject will walk on the treadmill with partial body weight support. This protocol will be repeated in all sessions.
Primary Outcome Measure Information:
Title
Change from Baseline in the gait velocity
Description
Speed at which subjects walked measured by the 10 meters test
Time Frame
Baseline, immediately after and six weeks after training cessation.
Secondary Outcome Measure Information:
Title
Distribution of body weight
Description
Body weight Distribution measured while subjects are in a static position on two force platforms.
Time Frame
Baseline, immediately after and six weeks after training cessation.
Title
Functional independence
Description
a score was assigned for each everyday activity, according to the amount of assistance required to perform it. Measured by a clinical scale (Functional Independence Measure Scale.
Time Frame
Baseline, immediately after and six weeks after training cessation.
Title
Lower limb recovery
Description
Measured by a clinical scale (Fulgy Meyer).
Time Frame
Baseline, immediately after and six weeks after training cessation.
Title
Endurance
Description
Measured by the 6 minutes walking test
Time Frame
Baseline, immediately after and six weeks after training cessation.
Other Pre-specified Outcome Measures:
Title
Spacial and temporal variables
Description
Measured while subjects are walking at a comfortable speed
Time Frame
Baseline, immediately after and six weeks after training cessation.
Title
Center of Pressure
Description
Behavior of the Center of Pressure in gait and gait initiation measured by the force plates during the gait and gait initiation. Center of Pressure distance and seed displacement will be measured during the task.
Time Frame
Baseline, immediately after and six weeks after training cessation.
Title
articular and segment angles
Description
Measured while subjects are walking at a comfortable speed
Time Frame
Baseline, immediately after and six weeks after training cessation.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
One-sided hemiparesis, No heart disease (or medical clearance to participate in the study), No orthopedic impairments and / or neurological symptoms that may alter the the gait, no history of thrombophlebitis or deep vein thrombosis, Ability to understand and follow verbal commands, Can walk alone or with canes of approximately 10 m; Spasticity degree mild to moderate in the affected lower limb with levels of classification between 0 and 2 in the Ashworth spasticity scale modified
Exclusion Criteria:
Heart frequency increase more than 75% of the maximum or have any other general instability during training that may lead risk for the health during the training,
Facility Information:
Facility Name
Cruzeiro do Sul University
City
São Paulo
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
28034719
Citation
Gama GL, Celestino ML, Barela JA, Forrester L, Whitall J, Barela AM. Effects of Gait Training With Body Weight Support on a Treadmill Versus Overground in Individuals With Stroke. Arch Phys Med Rehabil. 2017 Apr;98(4):738-745. doi: 10.1016/j.apmr.2016.11.022. Epub 2016 Dec 27.
Results Reference
derived
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Walking Training With Partial Body Weight Support on Static and Dynamic Surfaces in Stroke Survivers
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