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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02088255
• Other study ID #: CE/UCS-016/2013
• Status: Completed
• Phase: N/A
• First received: March 10, 2014
• Last updated: March 7, 2016
• Start date: March 2014
• Est. completion date: July 2015

Study information

• Verified date: July 2015
• Source: Universidade Cruzeiro do Sul
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Cruzeiro do Sul University Research Ethics Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Body Weight
• Stroke

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Cruzeiro do Sul University	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Cruzeiro do Sul

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Spacial and temporal variables	Measured while subjects are walking at a comfortable speed	Baseline, immediately after and six weeks after training cessation.	Yes
Other	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.	Yes
Other	articular and segment angles	Measured while subjects are walking at a comfortable speed	Baseline, immediately after and six weeks after training cessation.	Yes
Primary	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.	Yes
Secondary	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.	Yes
Secondary	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.	Yes
Secondary	Lower limb recovery	Measured by a clinical scale (Fulgy Meyer).	Baseline, immediately after and six weeks after training cessation.	Yes
Secondary	Endurance	Measured by the 6 minutes walking test	Baseline, immediately after and six weeks after training cessation.	Yes