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

• ClinicalTrials.gov Identifier: NCT02088255
• Recruitment Status: Completed
• First Posted: March 14, 2014
• Last Update Posted: March 8, 2016
• Sponsor: Universidade Cruzeiro do Sul
• Information provided by (Responsible Party): Gabriela Lopes Gama, Universidade Cruzeiro do Sul

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	Not Applicable

Study Design

• 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

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 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

Outcome Measures

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

Eligibility Criteria

• 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,

Contacts and Locations

Locations

Brazil

Cruzeiro do Sul University

São Paulo, Brazil

Sponsors and Collaborators

Universidade Cruzeiro do Sul

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• 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
• 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:

Stroke; Body Weight; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases