- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04438343
Impairment-Specific and Augmented Intervention on Turning
June 18, 2021 updated by: Yea-Ru Yang, National Yang Ming University
Effects of Impairment-Specific and Augmented Intervention on Turning Performance in Individuals With Chronic Stroke
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yea-Ru Yang
- Phone Number: +886228267279
- Email: yryang@nycu.edu.tw
Study Locations
-
-
Beitou
-
Taipei, Beitou, Taiwan, 112
- Recruiting
- Yea-Ru Yang
-
Contact:
- Yea-Ru Yang
- Phone Number: +886228267279
- Email: yryang@nycu.edu.tw
-
Principal Investigator:
- Yea-Ru Yang, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: experimental group
|
Balance and lower extremities strength training
|
Active Comparator: control group
|
Trunk and upper extremity training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Turning performance
Time Frame: Change from baseline at 4 week
|
Using a turning characteristic evaluation system to evaluate the swing time, stance time, turning speed, and stride length of the participants during turning
|
Change from baseline at 4 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Balance
Time Frame: Change from baseline at 4 week
|
Berg Balance Scale Limits of stability (LOS) using NeuroCom Smart Balance Master (NeuroCom International, Clackamas, OR)
|
Change from baseline at 4 week
|
Strength
Time Frame: Change from baseline at 4 week
|
Using handheld dynamometer
|
Change from baseline at 4 week
|
Straight walking performance
Time Frame: Change from baseline at 4 week
|
Using GAITRite system (CIR system, Inc, Havertown, PS) calculate walking speed, cadence, swing time, stance time, and step length
|
Change from baseline at 4 week
|
Timed up and go test
Time Frame: Change from baseline at 4 week
|
Change from baseline at 4 week
|
|
Falls Efficacy Scale International (Chinese)
Time Frame: Change from baseline at 4 week
|
Change from baseline at 4 week
|
|
Stroke Impact Scale (SIS) Taiwan version
Time Frame: Change from baseline at 4 week
|
Change from baseline at 4 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 11, 2020
Primary Completion (Anticipated)
December 31, 2021
Study Completion (Anticipated)
December 31, 2021
Study Registration Dates
First Submitted
June 16, 2020
First Submitted That Met QC Criteria
June 16, 2020
First Posted (Actual)
June 18, 2020
Study Record Updates
Last Update Posted (Actual)
June 22, 2021
Last Update Submitted That Met QC Criteria
June 18, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- YM109070F
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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