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

Study Locations

  • Taiwan
    • Beitou
      • Taipei, Beitou, Taiwan, 112
        • Recruiting
        • Yea-Ru Yang
        • Contact:
        • 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
Other: Impairment-specific and augmented intervention
Balance and lower extremities strength training
Active Comparator: control group
Other: Conventional physical therapy
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

National Yang Ming University

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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