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

Walking Training With Partial Body Weight Support on Static and Dynamic Surfaces in Individuals With Hemiparesis Due to Stroke

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

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Procedure: Static surface; Procedure: Dynamic surface

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil
    • Cruzeiro do Sul University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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,

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in the gait velocity	Speed at which subjects walked measured by the 10 meters test	Baseline, immediately after and six weeks after training cessation.

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Universidade Cruzeiro do Sul

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: March 10, 2014
• First Submitted That Met QC Criteria: March 13, 2014
• First Posted (Estimate): March 14, 2014

Study Record Updates

• Last Update Posted (Estimate): March 8, 2016
• Last Update Submitted That Met QC Criteria: March 7, 2016
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Rehabilitation; Stroke; Gait; Biomechanics
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Body Weight
• Other Study ID Numbers: CE/UCS-016/2013