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  • Status : Approved
    • First Submitted Date : 2020/07/27
    • Registered Date : 2020/07/30
    • Last Updated Date : 2020/07/27
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1. Background

Background Information
CRIS
Registration Number
KCT0005272 
Unique Protocol ID 2019-021-HR 
Public/Brief Title Effects of partial weight support ground walking gait training on stroke patients 
Scientific Title The effects of dual weight-assisted partial weight gait training on balance and gait speed in chronic stroke patients  
Acronym  
MFDS Regulated Study No
IND/IDE Protocol No
Registered
at Other Registry
No
Healthcare Benefit
Approval Status
Not applicable

2. Institutional Review Board/Ethics Committee

Institutional Review Board Information
Board Approval Status Submitted approval 
Board Approval Number 1040460-A-2019-037 
Approval Date 2019-06-03 
Institutional Review Board  
Name Kyungnam University Research Ethics Center 
Address 7, Gyeongnamdaehak-ro, Masanhappo-gu, Changwon-si, Gyeongsangnam-do 
Telephone 055-249-2290 
Data Monitoring Committee No  

3. Contact Details

Contact Details Information
Contact Person for Principal Investigator / Scientific Queries  
Name Park Dong Chun 
Title Physical therapist 
Telephone +82-55-580-5800 
Affiliation Kyungnam University 
Address 7, Gyeongnam Daehak-ro, Masanhappo-gu, Changwon-si, Gyeongsangnam-do 
Contact Person for Public Queries
Name Park Dong Chun 
Title Physical therapist 
Telephone +82-55-580-5800 
Affiliation Kyungnam University 
Address 7, Gyeongnam Daehak-ro, Masanhappo-gu, Changwon-si, Gyeongsangnam-do 
Contact Person for Updating Information
Name Park Dong Chun 
Title Physical therapist 
Telephone +82-55-580-5800 
Affiliation Kyungnam University 
Address 7, Gyeongnam Daehak-ro, Masanhappo-gu, Changwon-si, Gyeongsangnam-do 

4. Status

Status Information
Study Site Single
Overall Recruitment Status Completed  
Date of First Enrollment 2019-07-01 , Actual
Target Number of Participant 30
Primary Completion Date 2019-08-19 , Actual
Study Completion Date 2019-08-19 , Actual
Recruitment Status by Participating Study Site 1
Name of Study Site Saerom Rehabilitation Hospital 
Recruitment Status Completed  
Date of First Enrollment 2019-07-01 , Actual

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information
Source of Monetary/Material Support 1   
Organization Name Kyungnam University 
Organization Type University  
Project ID  

6. Sponsor Organization

Sponsor Organization Information
Sponsor Organization 1   
Organization Name Kyungnam University 
Organization Type University  

7. Study Summary

Study Summary Information
Lay Summary The purpose of this study is to investigate the effects of dual weight-assisted partial weight gait training on the balance and gait speed of chronic stroke patients.
Stroke patients have difficulty walking independently due to sensory damage and poor balance.
Through this study, we would like to provide basic data on the potential for clinical intervention in patients with chronic stroke.  

8. Study Design

Study Design Information
Study Type Interventional Study 
Study Purpose Treatment    
Phase Not applicable 
Intervention Model Parallel  
Blinding/Masking Double 
Blinded Subject Subject, Investigator 
Allocation RCT 
Intervention Type Others (Rehabilitation)
Intervention Description Experimental group: Partial weight support ground walking training combined with dual tasks was conducted 3 times a week for 6 weeks
Control group: General gait training combined with double tasks was conducted 3 times a week for 6 weeks  
Number of Arms
Arm 1 Arm Label Partial weight support ground walking group that combines dual tasks 
Target Number of Participant 15 
Arm Type Experimental 
Arm Description Partial weight support ground walking training combined with dual tasks was conducted 3 times a week for 6 weeks 
Arm 2 Arm Label General ground walker combined double task 
Target Number of Participant 15 
Arm Type Active comparator 
Arm Description General ground walking training combined with dual tasks is conducted 3 times a week for 6 weeks 

9. Subject Eligibility

Subject Eligibility Information
Condition(s) / Problem(s) * Diseases of the nervous system
 stroke
Rare Disease No
Inclusion
Criteria
Gender Both 
Age 60 Year ~ 65 Year
Description Those who have passed the diagnosis for more than 6 months <br />Those who do not have cerebellar disease.  
Exclusion Criteria People who have a disease that can affect walking. <br />The Mini-mental State Examination score is 21 or less.  
Healthy Volunteers No

10. Outcome Measure(s)

Outcome Measure(s) Information
Type of Primary Outcome Efficacy 
Primary Outcome(s) 1 
Outcome The walking speed in the group increased from 41.41.cm/s before the experiment to 18.98cm/s after the experiment and 60.39cm/s after the experiment, and showed a statistically significant difference (p<.05). The control group showed an increase of 1.97 cm/s after the experiment from 55.80 cm/s before the experiment to 57.77 cm/s, and there was no statistically significant difference (p>.05). As a result of comparison between groups, there was a statistically significant difference (p<.05). 
Timepoint September 1, 2019 
Secondary Outcome(s) 1 
Outcome Partial weight support training improves weight transfer ability, reduces the fear of falls to patients, and increases the gait speed by requiring therapist to gradually increase exercise control 
Timepoint September 1, 2019 

11. Study Results and Publication

Study Results and Publication Information
Result Registered No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information
Sharing Statement No 
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