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Kinesiotaping Effect Glenohumeral Shoulder Subluxation

Primary Purpose

Stroke, Subluxation, Glenohumeral

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
kinesiotape
Sponsored by
Ankara Physical Medicine and Rehabilitation Education and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Kinesiotape

    Arm Description

    Kinesiotape (Nasara, Korea) was applied for three times a week (Monday, Wednesday, and Friday) for three weeks.

    Outcomes

    Primary Outcome Measures

    Subluxation degree by physical examination
    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
    Subluxation degree by radiograph
    The anterio-posterior shoulder X-ray was taken in an erect position, and subluxation was evaluated by Van Langenberghe's five point classification.
    physical examination
    Passive range of motion (Flexion and Abduction)

    Secondary Outcome Measures

    Evaluation of the pain of the shoulder
    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)
    Evaluation of Daily life activities
    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.

    Full Information

    First Posted
    July 9, 2020
    Last Updated
    July 11, 2020
    Sponsor
    Ankara Physical Medicine and Rehabilitation Education and Research Hospital
    Collaborators
    Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04468750
    Brief Title
    Kinesiotaping Effect Glenohumeral Shoulder Subluxation
    Official Title
    The Effect of Kinesiotaping on Glenohumeral Shoulder Subluxation in Post-stroke Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    November 13, 2013 (Actual)
    Primary Completion Date
    July 15, 2015 (Actual)
    Study Completion Date
    June 6, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Ankara Physical Medicine and Rehabilitation Education and Research Hospital
    Collaborators
    Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    To evaluate the effectiveness of the kinesiotaping on pain, recovery of movement and daily life activities in Turkish hemiplegic patients.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke, Subluxation, Glenohumeral

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    This study is a quasi-experimental, single-subject AB design.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    14 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Kinesiotape
    Arm Type
    Experimental
    Arm Description
    Kinesiotape (Nasara, Korea) was applied for three times a week (Monday, Wednesday, and Friday) for three weeks.
    Intervention Type
    Device
    Intervention Name(s)
    kinesiotape
    Intervention Description
    During the rehabilitation program, all patients with GHS had kinesiotaping three times a week.
    Primary Outcome Measure Information:
    Title
    Subluxation degree by physical examination
    Description
    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
    Time Frame
    0-3weeks
    Title
    Subluxation degree by radiograph
    Description
    The anterio-posterior shoulder X-ray was taken in an erect position, and subluxation was evaluated by Van Langenberghe's five point classification.
    Time Frame
    0-3weeks
    Title
    physical examination
    Description
    Passive range of motion (Flexion and Abduction)
    Time Frame
    0-3weeks
    Secondary Outcome Measure Information:
    Title
    Evaluation of the pain of the shoulder
    Description
    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)
    Time Frame
    0-3weeks
    Title
    Evaluation of Daily life activities
    Description
    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.
    Time Frame
    0-3weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Halil Ucan, MD
    Organizational Affiliation
    Ankara Physical Medicine and Rehabilitation Education and Research Hospital
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Kinesiotaping Effect Glenohumeral Shoulder Subluxation

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