- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04468750
Kinesiotaping Effect Glenohumeral Shoulder Subluxation
July 11, 2020 updated by: Ankara Physical Medicine and Rehabilitation Education and Research Hospital
The Effect of Kinesiotaping on Glenohumeral Shoulder Subluxation in Post-stroke Patients
To evaluate the effectiveness of the kinesiotaping on pain, recovery of movement and daily life activities in Turkish hemiplegic patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Not Applicable
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
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- (1) 18 to 90 years of age, (2) stroke onset within one year, (3) shoulder subluxation in the involved upper extremity and (4) being oriented and cooperative.
Exclusion Criteria:
- (1) global aphasia, (2) malignancy, (3) previous shoulder pain or surgery, (4) other neuromuscular disorders and (5) severe cardiopulmonary disease that affects daily life activities.
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Kinesiotape
Kinesiotape (Nasara, Korea) was applied for three times a week (Monday, Wednesday, and Friday) for three weeks.
|
During the rehabilitation program, all patients with GHS had kinesiotaping three times a week.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Subluxation degree by physical examination
Time Frame: 0-3weeks
|
A clinician measured the gap between the acromion and the humeral head with the fingerbreadth at the distal interphalangeal joint of the right index and middle fingers
|
0-3weeks
|
|
Subluxation degree by radiograph
Time Frame: 0-3weeks
|
The anterio-posterior shoulder X-ray was taken in an erect position, and subluxation was evaluated by Van Langenberghe's five point classification.
|
0-3weeks
|
|
physical examination
Time Frame: 0-3weeks
|
Passive range of motion (Flexion and Abduction)
|
0-3weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluation of the pain of the shoulder
Time Frame: 0-3weeks
|
Pain with motion was measured by a verbal descriptive pain scale.
The VDPS was developed by Melzack and Katz and is composed of words such as "mild" (level 1) to "very severe pain" (level 5)
|
0-3weeks
|
|
Evaluation of Daily life activities
Time Frame: 0-3weeks
|
Daily life activities were evaluated using the Katz index of independence in activities of daily living, which evaluates the patients in bathing, dressing, toileting, transferring, continence, and eating.
Activities were scored as zero or one with the total score ranging from zero to six.
Higher scores are related with higher independency.
|
0-3weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Halil Ucan, MD, Ankara Physical Medicine and Rehabilitation Education and Research Hospital
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)
November 13, 2013
Primary Completion (Actual)
July 15, 2015
Study Completion (Actual)
June 6, 2018
Study Registration Dates
First Submitted
July 9, 2020
First Submitted That Met QC Criteria
July 9, 2020
First Posted (Actual)
July 13, 2020
Study Record Updates
Last Update Posted (Actual)
July 14, 2020
Last Update Submitted That Met QC Criteria
July 11, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5416
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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