StrokeNCT04468750
Kinesiotaping Effect Glenohumeral Shoulder Subluxation
A study testing kinesiotape in people with Stroke and Subluxation, Glenohumeral, run by Ankara Physical Medicine and Rehabilitation Education and Research Hospital.
Trial summary
To evaluate the effectiveness of the kinesiotaping on pain, recovery of movement and daily life activities in Turkish hemiplegic patients. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Stroke, Subluxation, Glenohumeral
- What is being tested?
- kinesiotape
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- 13 Nov 2013to 6 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (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.
Who cannot join
- (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.
About this study
Official title: 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.
- Conditions
- Stroke, Subluxation, Glenohumeral
- Being tested
- kinesiotape
- Medical subject headings
- Stroke, Shoulder Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
kinesiotapeDevice
During the rehabilitation program, all patients with GHS had kinesiotaping three times a week.
| Study group | Role | What they receive |
|---|---|---|
| Kinesiotape | Experimental | Kinesiotape (Nasara, Korea) was applied for three times a week (Monday, Wednesday, and Friday) for three weeks. Receives: Device: kinesiotape |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 0-3weeks
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.
Measured: 0-3weeks
physical examination
Passive range of motion (Flexion and Abduction)
Measured: 0-3weeks
Secondary outcomes (2)
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)
Measured: 0-3weeks
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.
Measured: 0-3weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study start13 Nov 2013
- Primary completion15 Jul 2015
- Study completion6 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study is a quasi-experimental, single-subject AB design.
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Physical Medicine and Rehabilitation Education and Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Responsible party
- Sponsor
- Investigators
- Halil Ucan, MD, Study director, Ankara Physical Medicine and Rehabilitation Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04468750
- Sponsor's protocol ID
- 5416
- Status last verified
- Jul 2020
- First submitted
- 9 Jul 2020
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Kinesiotaping on Glenohumeral Shoulder Subluxation in Post-stroke Patients
- ClinicalTrials.gov ID
- NCT04468750
- Acronym / sponsor ID
- 5416
- Conditions
- Stroke, Subluxation, Glenohumeral
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Ankara Physical Medicine and Rehabilitation Education and Research HospitalUniversity, hospital or other
- Collaborators
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Study start
- 13 Nov 2013 (actual)
- Primary completion
- 15 Jul 2015 (actual)
- Study completion
- 6 Jun 2018 (actual)
- First posted
- 13 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the effectiveness of the kinesiotaping on pain, recovery of movement and daily life activities in Turkish hemiplegic patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study is a quasi-experimental, single-subject AB design.
| Arm | Type | Receives |
|---|---|---|
| Kinesiotape | Experimental | Device: kinesiotapeKinesiotape (Nasara, Korea) was applied for three times a week (Monday, Wednesday, and Friday) for three weeks. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- (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.
Key exclusion criteria (1 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| kinesiotapeDuring the rehabilitation program, all patients with GHS had kinesiotaping three times a week. | Device | Kinesiotape |
Primary outcome
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
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.
physical examination
Time frame: 0-3weeks
Passive range of motion (Flexion and Abduction)
2 secondary outcomes
Evaluation of the pain of the shoulder
Time frame: 0-3weeks
Evaluation of Daily life activities
Time frame: 0-3weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Halil Ucan, MD study director
Ankara Physical Medicine and Rehabilitation Education and Research Hospital
Questions about this trial
What is this clinical trial studying?
A study testing kinesiotape in people with Stroke and Subluxation, Glenohumeral, run by Ankara Physical Medicine and Rehabilitation Education and Research Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subluxation degree by physical examination (time frame: 0-3weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2020.