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Walking Training With Partial Body Weight Support on Static and Dynamic Surfaces in Stroke Survivers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02088255
Recruitment Status : Completed
First Posted : March 14, 2014
Last Update Posted : March 8, 2016
Sponsor:
Information provided by (Responsible Party):
Gabriela Lopes Gama, Universidade Cruzeiro do Sul

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

Condition or disease Intervention/treatment Phase
Stroke Procedure: Static surface Procedure: Dynamic surface Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Walking Training With Partial Body Weight Support on Static and Dynamic Surfaces in Individuals With Hemiparesis Due to Stroke
Study Start Date : March 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
Active Comparator: Static surface
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
Procedure: Static surface
During all session time the subject will walk on the floor with partial body weight support. This protocol will be repeated in all sessions.
Other Name: floor walking training

Active Comparator: dynamic surface
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
Procedure: Dynamic surface
During all session time the subject will walk on the treadmill with partial body weight support. This protocol will be repeated in all sessions.
Other Name: Treadmill Training




Primary Outcome Measures :
  1. Change from Baseline in the gait velocity [ Time Frame: Baseline, immediately after and six weeks after training cessation. ]
    Speed at which subjects walked measured by the 10 meters test


Secondary Outcome Measures :
  1. Distribution of body weight [ Time Frame: Baseline, immediately after and six weeks after training cessation. ]
    Body weight Distribution measured while subjects are in a static position on two force platforms.

  2. Functional independence [ Time Frame: Baseline, immediately after and six weeks after training cessation. ]
    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.

  3. Lower limb recovery [ Time Frame: Baseline, immediately after and six weeks after training cessation. ]
    Measured by a clinical scale (Fulgy Meyer).

  4. Endurance [ Time Frame: Baseline, immediately after and six weeks after training cessation. ]
    Measured by the 6 minutes walking test


Other Outcome Measures:
  1. Spacial and temporal variables [ Time Frame: Baseline, immediately after and six weeks after training cessation. ]
    Measured while subjects are walking at a comfortable speed

  2. Center of Pressure [ Time Frame: Baseline, immediately after and six weeks after training cessation. ]
    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.

  3. articular and segment angles [ Time Frame: Baseline, immediately after and six weeks after training cessation. ]
    Measured while subjects are walking at a comfortable speed



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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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,

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02088255


Locations
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Brazil
Cruzeiro do Sul University
São Paulo, Brazil
Sponsors and Collaborators
Universidade Cruzeiro do Sul
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gabriela Lopes Gama, Principal Investigator, Universidade Cruzeiro do Sul
ClinicalTrials.gov Identifier: NCT02088255    
Other Study ID Numbers: CE/UCS-016/2013
First Posted: March 14, 2014    Key Record Dates
Last Update Posted: March 8, 2016
Last Verified: July 2015
Keywords provided by Gabriela Lopes Gama, Universidade Cruzeiro do Sul:
Rehabilitation
Gait
Stroke
Biomechanics
Additional relevant MeSH terms:
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Stroke
Body Weight
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases