Effect of Anterioposterior Weight Shifting Training With Visual Biofeedback in Subacute Stroke
Primary Purpose
Stroke
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
anterioposterior Weight Shifting Training with Visual Biofeedback
Conventional therapy
Sponsored by

About this trial
This is an interventional treatment trial for Stroke
Eligibility Criteria
Inclusion Criteria:
- less than 6 months after onset of the stroke
- can stand and walk independently 10m
- K-MMSE score of at least 15
- have asymmetrical gait pattern with Step length asymmetric ratio greater than 1.1
- over 20 years of age.
Exclusion Criteria:
- quadriplegia
- past history of stroke
- past history of Musculoskeletal disease or history of Neurological diseases
Sites / Locations
- Department and Research Institute of Rehabilitation Medicine, Yonsei University College of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Training group
Control group
Arm Description
Outcomes
Primary Outcome Measures
Step Length Asymmetric Ratio
Step Length Asymmetric Ratio = paretic step length/non paretic step length
Step Length Asymmetric Ratio
Step Length Asymmetric Ratio = paretic step length/non paretic step length
Step Length Asymmetric Ratio
Step Length Asymmetric Ratio = paretic step length/non paretic step length
Step Length Asymmetric Ratio
Step Length Asymmetric Ratio = paretic step length/non paretic step length
Step Length Asymmetric Index
Step Length Asymmetric Index = paretic step length-non paretic step length/0.5[paretic step length +non paretic step length]
Step Length Asymmetric Index
Step Length Asymmetric Index = paretic step length-non paretic step length/0.5[paretic step length +non paretic step length]
Step Length Asymmetric Index
Step Length Asymmetric Index = paretic step length-non paretic step length/0.5[paretic step length +non paretic step length]
Step Length Asymmetric Index
Step Length Asymmetric Index = paretic step length-non paretic step length/0.5[paretic step length +non paretic step length]
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04637737
Brief Title
Effect of Anterioposterior Weight Shifting Training With Visual Biofeedback in Subacute Stroke
Official Title
Effect of Anterioposterior Weight Shifting Training With Visual Biofeedback in Subacute Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2014 (undefined)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
June 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Asymmetric gait patterns of stroke is one of the most important functional activities to enable community participation, it is major goal for stroke patients. Reported that the stroke patients had asymmetry at stance time, single stance, double support time, and swing time compared to normal people, and claimed that the most important factor was step length. According to Albert et al., patients with an asymmetric gait pattern have a long double support phase and a healthy side single support phase, and less weight shift to the affected side. Recent studies have shown that visual feedback for weight shift may be helpful to obtain a symmetrical posture after stroke. However, no study has been conducted on the therapeutic effect on gait asymmetry and patterns. We aimed to investigate the effect of Anterioposterior Weight Shifting Training with Visual Biofeedback in subacute post-stroke patients on gait asymmetry and pattern.
40 subacute post-stroke patients with Step Length Asymmetry were enrolled in this study. The subjects were randomly assigned into two groups. The training group received an additional anterioposterior weight shifting training with visual Biofeedback 5 times per week for 4weeks. The control group received the usual gait training. The spatiotemporal and kinematic data were obtained during walking through 3D motion analysis. Functional Ambulation Category, Self-selected walking speed, Maximum safe walking speed, Berg balance Test (BBT), Fugl-Meyer Assessment (FMA), Medical Research Council Score (MRC), Functional Independent Measure-mobility, Timed Up and Go test (TUG) were assessed at pre, during, post- training, and 4week follow-up. Those were compared between two groups by repeated measures ANOVA.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Training group
Arm Type
Experimental
Arm Title
Control group
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
anterioposterior Weight Shifting Training with Visual Biofeedback
Intervention Description
The training group received an additional anterioposterior weight shifting training with visual Biofeedback 5 times per week for 4weeks. AP training is made to instantly know your training status during training by measuring and processing the foot pressure in real time using the F-Scan (Tekscan) hardware system and Software Development Kit (SDK).
Before training, all patients are instructed to place both feet at shoulder width, place the inverted foot approximately 30 cm in front of the unaffected side foot, move the body forward with the chest straight in an upright position, and be instructed to put the weight on the affected side.
On the screen shown, measure the maximum weight distribution during the first 10 times and set the value added by 5% as the target value.
It is designed to induce the maximum weight shift through the archery game.
Intervention Type
Behavioral
Intervention Name(s)
Conventional therapy
Intervention Description
The control group received the usual gait training.
Primary Outcome Measure Information:
Title
Step Length Asymmetric Ratio
Description
Step Length Asymmetric Ratio = paretic step length/non paretic step length
Time Frame
before training(0week)
Title
Step Length Asymmetric Ratio
Description
Step Length Asymmetric Ratio = paretic step length/non paretic step length
Time Frame
during training(2week)
Title
Step Length Asymmetric Ratio
Description
Step Length Asymmetric Ratio = paretic step length/non paretic step length
Time Frame
after training(4week)
Title
Step Length Asymmetric Ratio
Description
Step Length Asymmetric Ratio = paretic step length/non paretic step length
Time Frame
Follow up(8week)
Title
Step Length Asymmetric Index
Description
Step Length Asymmetric Index = paretic step length-non paretic step length/0.5[paretic step length +non paretic step length]
Time Frame
before training(0week)
Title
Step Length Asymmetric Index
Description
Step Length Asymmetric Index = paretic step length-non paretic step length/0.5[paretic step length +non paretic step length]
Time Frame
during training(2week)
Title
Step Length Asymmetric Index
Description
Step Length Asymmetric Index = paretic step length-non paretic step length/0.5[paretic step length +non paretic step length]
Time Frame
after training(4week)
Title
Step Length Asymmetric Index
Description
Step Length Asymmetric Index = paretic step length-non paretic step length/0.5[paretic step length +non paretic step length]
Time Frame
Follow up(8week)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
less than 6 months after onset of the stroke
can stand and walk independently 10m
K-MMSE score of at least 15
have asymmetrical gait pattern with Step length asymmetric ratio greater than 1.1
over 20 years of age.
Exclusion Criteria:
quadriplegia
past history of stroke
past history of Musculoskeletal disease or history of Neurological diseases
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Deog Young Kim
Phone
+82-2-2228-3714
Email
KIMDY@yuhs.ac
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deog Young Kim
Organizational Affiliation
Severance Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department and Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deog Young Kim
Phone
+82-2-2228-3714
Email
KIMDY@yuhs.ac
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Anterioposterior Weight Shifting Training With Visual Biofeedback in Subacute Stroke
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