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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02029664
Other study ID # NRC-2013-04-037
Secondary ID
Status Recruiting
Phase N/A
First received December 28, 2013
Last updated October 23, 2016
Start date January 2014

Study information

Verified date October 2016
Source National Rehabilitation Center, Seoul, Korea
Contact Joon-Ho Shin, MS
Phone 82-10-3168-7043
Email asfreelyas@gmail.com
Is FDA regulated No
Health authority Korea: Ministry of Food and Drug SafetyKorea: Ministry for Health and WelfareUnited States: Federal Government
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine the possibility of gait pattern change via visual feedback among patients with stroke. Also, the optimal visual feedback would be chosen from this study.


Recruitment information / eligibility

Status Recruiting
Enrollment 64
Est. completion date
Est. primary completion date December 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Hemiplegic stroke patients >= 18 years old

- Functional Ambulation Category >=3

- Cognitively intact enough to follow the study protocol

- Adults without any gait problem

Exclusion Criteria:

- Quadriplegic stroke patients

- Orthopedic problems to affect gait

- Underlying other neurological or psychological disorders

- Spasticity or contracture which impede the gait.

- Uncontrolled medical problems

- Pregnant.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Device:
Visual distortion increment based on the gait pattern


Locations

Country Name City State
Korea, Republic of National Rehabilitation Center Seoul

Sponsors (1)

Lead Sponsor Collaborator
National Rehabilitation Center, Seoul, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Step length symmetry Step length symmetry during treadmill gait. When the participants walk on the treadmill, the walk symmetry was calculated from the sensor attached to them.
During the whole period of treadmill gait, step length asymmetry will be recorded.
Participants will be followed for the duration of treadmill gait, an expected average of 15 minutes No
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