Impairment-Specific and Augmented Intervention on Turning

Stroke Clinical Trial

Official title:

Effects of Impairment-Specific and Augmented Intervention on Turning Performance in Individuals With Chronic Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04438343
• Other study ID #: YM109070F
• Status: Recruiting
• Phase: N/A
• Start date: September 11, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: June 2021
• Source: National Yang Ming University
• Contact: Yea-Ru Yang
• Phone: +886228267279
• Email: yryang[@]nycu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Impairment-specific and augmented intervention
Balance and lower extremities strength training
• Conventional physical therapy
Trunk and upper extremity training

Locations

Country	Name	City	State
Taiwan	Yea-Ru Yang	Taipei	Beitou

Sponsors (1)

Lead Sponsor	Collaborator
National Yang Ming University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from baseline at 4 week
Secondary	Balance	Berg Balance Scale Limits of stability (LOS) using NeuroCom Smart Balance Master (NeuroCom International, Clackamas, OR)	Change from baseline at 4 week
Secondary	Strength	Using handheld dynamometer	Change from baseline at 4 week
Secondary	Straight walking performance	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
Secondary	Timed up and go test		Change from baseline at 4 week
Secondary	Falls Efficacy Scale International (Chinese)		Change from baseline at 4 week
Secondary	Stroke Impact Scale (SIS) Taiwan version		Change from baseline at 4 week