NCT02207933

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Jun 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 31, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 4, 2014

Completed
Last Updated

March 27, 2019

Status Verified

December 1, 2014

Enrollment Period

1.1 years

First QC Date

July 31, 2014

Last Update Submit

March 26, 2019

Conditions

Keywords

anterioposteriorweightshiftingtrainingpatient

Outcome Measures

Primary Outcomes (1)

  • change of step Length Asymmetric Ratio

    paretic step length/non paretic step length

    baseline, 3 weeks, 6 weeks, 12 weeks

Secondary Outcomes (1)

  • change of Step Length Asymmetric Index

    baseline, 3 weeks, 6 weeks, 12 weeks

Study Arms (2)

AP shifting group

EXPERIMENTAL
Procedure: AP shifting training

gait training group

ACTIVE COMPARATOR
Procedure: Gait training

Interventions

AP shifting training in addition to gait training 3 times a week for 6 weeks

AP shifting group
Gait trainingPROCEDURE

Gait training only for 3 times a week for 6 weeks.

gait training group

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance hospital

Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

StrokeGait Disorders, NeurologicBody Weight

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Deog Young Kim, MD, PhD

    Severance Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2014

First Posted

August 4, 2014

Study Start

June 1, 2013

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

March 27, 2019

Record last verified: 2014-12

Locations