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

Sponsor

Universidade Cruzeiro do Sul (Other)

Overall Status

Completed

CT.gov ID

NCT02088255

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.8

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Stroke	Procedure: Static surface Procedure: Dynamic surface	N/A

Study Design

Study Type:

Interventional

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 :

Mar 1, 2014

Actual Primary Completion Date :

Jul 1, 2015

Actual Study Completion Date :

Jul 1, 2015

Arms and Interventions

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 Names: 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 Names: Treadmill Training

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 Names:

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 Names:

Treadmill Training

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Distribution of body weight [Baseline, immediately after and six weeks after training cessation.]
Body weight Distribution measured while subjects are in a static position on two force platforms.
Functional independence [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.
Lower limb recovery [Baseline, immediately after and six weeks after training cessation.]
Measured by a clinical scale (Fulgy Meyer).
Endurance [Baseline, immediately after and six weeks after training cessation.]
Measured by the 6 minutes walking test

Other Outcome Measures

Spacial and temporal variables [Baseline, immediately after and six weeks after training cessation.]
Measured while subjects are walking at a comfortable speed
Center of Pressure [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.
articular and segment angles [Baseline, immediately after and six weeks after training cessation.]
Measured while subjects are walking at a comfortable speed

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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,