Back to resultsImpairment-Specific and Augmented Intervention on Turning
Primary Purpose
Stroke
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Impairment-specific and augmented intervention
Conventional physical therapy
Sponsored by
About this trial
This is an interventional treatment trial for Stroke
Eligibility Criteria
Inclusion Criteria:
- ≧ 6 months post first-ever stroke with unilateral motor deficits
- ≧20 years of age
- The ability to walk independently for at least 7 m with or without using walking aids
- Score ≧ 24 of 30 on the Mini-Mental State Examination
Exclusion Criteria:
- Unstable medical conditions (e.g., deep vein thrombosis, aspiration pneumonia, or superimposed sepsis)
- History of other diseases known to interfere with participation in the study (e.g., heart failure, hemineglect, or diabetic neuropathy)
Sites / Locations
- Yea-Ru YangRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
experimental group
control group
Arm Description
Outcomes
Primary Outcome Measures
Turning performance
Using a turning characteristic evaluation system to evaluate the swing time, stance time, turning speed, and stride length of the participants during turning
Secondary Outcome Measures
Balance
Berg Balance Scale Limits of stability (LOS) using NeuroCom Smart Balance Master (NeuroCom International, Clackamas, OR)
Strength
Using handheld dynamometer
Straight walking performance
Using GAITRite system (CIR system, Inc, Havertown, PS) calculate walking speed, cadence, swing time, stance time, and step length
Timed up and go test
Falls Efficacy Scale International (Chinese)
Stroke Impact Scale (SIS) Taiwan version
Full Information
NCT ID
NCT04438343
First Posted
June 16, 2020
Last Updated
June 18, 2021
Sponsor
National Yang Ming University
1. Study Identification
Unique Protocol Identification Number
NCT04438343
Brief Title
Impairment-Specific and Augmented Intervention on Turning
Official Title
Effects of Impairment-Specific and Augmented Intervention on Turning Performance in Individuals With Chronic Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 11, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Yang Ming University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The objective of this study is to investigate the effects of the impairment-specific and augmented intervention based balance and strength training on turning performance in individuals with chronic stroke.
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
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
experimental group
Arm Type
Experimental
Arm Title
control group
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Impairment-specific and augmented intervention
Intervention Description
Balance and lower extremities strength training
Intervention Type
Other
Intervention Name(s)
Conventional physical therapy
Intervention Description
Trunk and upper extremity training
Primary Outcome Measure Information:
Title
Turning performance
Description
Using a turning characteristic evaluation system to evaluate the swing time, stance time, turning speed, and stride length of the participants during turning
Time Frame
Change from baseline at 4 week
Secondary Outcome Measure Information:
Title
Balance
Description
Berg Balance Scale Limits of stability (LOS) using NeuroCom Smart Balance Master (NeuroCom International, Clackamas, OR)
Time Frame
Change from baseline at 4 week
Title
Strength
Description
Using handheld dynamometer
Time Frame
Change from baseline at 4 week
Title
Straight walking performance
Description
Using GAITRite system (CIR system, Inc, Havertown, PS) calculate walking speed, cadence, swing time, stance time, and step length
Time Frame
Change from baseline at 4 week
Title
Timed up and go test
Time Frame
Change from baseline at 4 week
Title
Falls Efficacy Scale International (Chinese)
Time Frame
Change from baseline at 4 week
Title
Stroke Impact Scale (SIS) Taiwan version
Time Frame
Change from baseline at 4 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
≧ 6 months post first-ever stroke with unilateral motor deficits
≧20 years of age
The ability to walk independently for at least 7 m with or without using walking aids
Score ≧ 24 of 30 on the Mini-Mental State Examination
Exclusion Criteria:
Unstable medical conditions (e.g., deep vein thrombosis, aspiration pneumonia, or superimposed sepsis)
History of other diseases known to interfere with participation in the study (e.g., heart failure, hemineglect, or diabetic neuropathy)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yea-Ru Yang
Phone
+886228267279
Email
yryang@nycu.edu.tw
Facility Information:
Facility Name
Yea-Ru Yang
City
Taipei
State/Province
Beitou
ZIP/Postal Code
112
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yea-Ru Yang
Phone
+886228267279
Email
yryang@nycu.edu.tw
First Name & Middle Initial & Last Name & Degree
Yea-Ru Yang, PhD
12. IPD Sharing Statement
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Impairment-Specific and Augmented Intervention on Turning
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