Impairment-Specific and Augmented Intervention on Turning

Sponsor

National Yang Ming University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04438343

Collaborator

(none)

Enrollment

Location

Arms

15.6

Anticipated Duration (Months)

2.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Other: Impairment-specific and augmented intervention Other: Conventional physical therapy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 11, 2020

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Dec 31, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Turning performance [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

Secondary Outcome Measures

Balance [Change from baseline at 4 week]
Berg Balance Scale Limits of stability (LOS) using NeuroCom Smart Balance Master (NeuroCom International, Clackamas, OR)
Strength [Change from baseline at 4 week]
Using handheld dynamometer
Straight walking performance [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
Timed up and go test [Change from baseline at 4 week]
Falls Efficacy Scale International (Chinese) [Change from baseline at 4 week]
Stroke Impact Scale (SIS) Taiwan version [Change from baseline at 4 week]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yea-Ru Yang	Taipei	Beitou	Taiwan	112

Sponsors and Collaborators

National Yang Ming University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yea-Ru Yang, Professor, National Yang Ming University

ClinicalTrials.gov Identifier:

NCT04438343

Other Study ID Numbers:

YM109070F

First Posted:

Jun 18, 2020

Last Update Posted:

Jun 22, 2021

Last Verified:

Jun 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Stroke

Study Results

No Results Posted as of Jun 22, 2021