Effect of Anterioposterior Weight Shifting Training With... | NCT02207933

Studies
Effect of Anterioposterior Weight Shifting Training With Visual Biofeedback in Patients With Step Length Asymmetry After Stroke

NCT02207933

Sponsor

Yonsei University

Status

Completed

Last Update Posted

Mar 27, 2019Actual

Enrollment

34Actual

Phase

Not Applicable

Conditions

Stroke
Hemiplegic Gait

Interventions

AP shifting training
Gait training

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2013

Primary Completion Date

Jul 2014Actual

Completion Date

Jul 2014Actual

First Submitted Date

Jul 31, 2014

First Submission Date that Met QC Criteria

Aug 1, 2014

First Posted Date

Aug 4, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 26, 2019

Last Update Posted Date

Mar 27, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To investigate the effect of anteroposterior weight shifting training with visual biofeedback on step length asymmetry. Reduced speed and asymmetry of stepping is a specific characteristic of hemiplegic gait. Asymmetry of stepping is characterized by shorter step length of the unaffected limb compared to the affected limb. Causes of this phenomenon are difficulty in weight bearing at the affected limb, weak propulsive force of the affected limb, and decreased strength of hip extensors. To correct these factors. we have developed an anteroposterior weight shifting training system with visual feedback and studied its effects.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

34Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AP shifting group	Experimental		Procedure: AP shifting training
gait training group	Active Comparator		Procedure: Gait training

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AP shifting training	Procedure	AP shifting training in addition to gait training 3 times a week for 6 weeks	AP shifting group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
change of step Length Asymmetric Ratio	paretic step length/non paretic step length	baseline, 3 weeks, 6 weeks, 12 weeks

Secondary Outcomes

Measure	Description	Time Frame
change of Step Length Asymmetric Index	paretic step length-non paretic step length/0.5[paretic step length +non paretic step length](streamdown:incomplete-link)	baseline, 3 weeks, 6 weeks, 12 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Independent standing
Ability to walk 10m without manual assistance
Asymmetric ratio of step length > 1.1
No severe perceptual, cognitive or cardiovascular impairments that could affect walking

Exclusion Criteria:

Quadriplegia or double hemiplegia
Orthopedic or neurologic conditions in addition to the stroke
Had more than 1 cerebrovascular accident

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Deog Young Kim, MD, PhD	Severance Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Severance hospital		Seoul		120-752	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D020521	Stroke
D020233	Gait Disorders, Neurologic
D001835	Body Weight

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided