StrokeNCT04425811
The Effect of Kinesiological Taping Applied to the Tibialis Anterior Muscle on Gait Parameter in Stroke Patients
A study testing kinesiological taping in people with Stroke, run by Istanbul Rumeli University at 1 site in Turkey (Türkiye).
Trial summary
The effect of kinesiological taping applied to the tibialis anterior muscle on gait parameter in stroke patients: Sham controlled study Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Stroke
- What is being tested?
- kinesiological taping
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Jun 2018to 5 May 2020
- 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 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 28 stroke individuals (hemiplegic / hemiparetic) who were treated in the Adult
- Neurological Rehabilitation Unit of Pamukkale University Medical Faculty Hospital were included in the study.
- Being between the ages of 25-70
- Volunteers with written consent
- With a 1-year history of stroke
- Who had a stroke for the first time
- Having a lesion in one brain hemisphere
Who cannot join
- Having neurological or orthopedic comorbid disease
- Patients with a gastrocnemius spasticity greater than 2 according to the modified ashworth scale
- Patients with communication problems
- Patients with cognitive functions below 7 points according to the Hodkinson Mental Test
- Patients with ambulation level below 3 according to Functional Ambulation Classification
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Kinesiological Taping Applied to the Tibialis Anterior Muscle on Gait Parameter in Stroke Patients: Sham Controlled Study
The effect of kinesiological taping applied to the tibialis anterior muscle on gait parameter in stroke patients: Sham controlled study
Read the detailed description
Objective: The aim of this study was to compare the immediate effect of kinesiological and / or sham taping to the tibialis anterior muscle on walking parameters in stroke individuals.
Methods: The study included 28 adults stroke patients . The subjects who received scores of 7 or more in the Hodkinson Mental Test and 3 and above in the Functional Ambulation Classification with subjects who gastrocnemius muscle spasticity 2 and below points according to Modified Ashworth Scale were included in the study. The walking parameters of the participants were evaluated with the BTS G-Walk Spatio-Temporal Walking Analysis System. The walking parameters of the participants who were selected by randomization method were evaluated separately by applying kinesiological taping and sham taping or without any taping or interference on a 10 meter track.
- Conditions
- Stroke
- Being tested
- kinesiological taping
- Keywords
- Stroke, Kinesiological Taping, Walking, Tibialis Anterior
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
kinesiological tapingOther
The kinesiological banding applied to the tibialis anterior muscle was applied to improve walking parameters and compared to sham control.
| Study group | Role | What they receive |
|---|---|---|
| No tape applied | No intervention | Walking parameters were evaluated without any intervention. |
| Kinesiological Tape | Experimental | Walking parameters were evaluated after kinesiological taping on the tibialis anterior muscle Receives: Other: kinesiological taping |
| Sham taping | Sham comparator | Walking parameters were evaluated after sham taping on the tibialis anterior muscle Receives: Other: kinesiological taping |
What is being measured
The primary outcome is the main question the study is designed to answer.
non-taping walking parameter measurement
The dominant side lower extremity of the participants was determined as the first preferred lower limb to take steps when walking. Walking parameters of the participants included in the study were evaluated with BTS G-Walk Spatio-Temporal Gait Analysis System. Before the banding applications of the patients, walking parameters were measured by asking them to walk with a shoe that they always use daily with the command "walk normally" on a 10-meter course, and stop with the command "stop" after 10 meters.
Measured: 2 hours
Secondary outcomes (2)
With kinesiological taping walking parameter measurement
Kinesiological taping or sham taping was performed by a certified physiotherapist 2 hours after the measurement of walking parameters without any intervention. Kinesiological banding for the tibialis anterior muscle was performed using muscle technique (stimulation). The taping was performed with the patients lying on a stretcher in the supine position. The kinesiological band was cut in the shape of I considering the participant's muscle length, the edges were ovalized, and the skin was purified from moisture, hair and oil. While applying the muscle technique (stimulation), the tibialis anterior muscle was stretched in the plantar flexion and eversion position. It was then activated by applying heat along the band. After the band was activated, the walking parameters of the participant were measured again with the BTS G-Walk device.
Measured: 2 hours
With sham taping walking parameter measurement
The sham taping was applied to the participants a week or a week before the application of the kinesiological tape. Sham taping application was applied to the same area as kinesiological taping application, but no technique was used. After the Sahm taping application, the walking parameters of the participants were measured again with the BTS G-Wlak device.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start14 Jun 2018
- Primary completion22 Jul 2019
- Study completion5 May 2020
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Sham Controlled Study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Rumeli University
- Sponsor type
- University, hospital or other
- Collaborators
- Pamukkale University
- Responsible party
- Principal investigator, Muammer Çorum, Istanbul Rumeli University
- Investigators
- Emre Baskan, Phd, Study director, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04425811
- Sponsor's protocol ID
- pamukkaleU
- Status last verified
- Jun 2020
- First submitted
- 4 Jun 2020
- Last updated
- 11 Jun 2020
- Results posted
- 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 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Kinesiological Taping Applied to the Tibialis Anterior Muscle on Gait Parameter in Stroke Patients: Sham Controlled Study
- ClinicalTrials.gov ID
- NCT04425811
- Acronym / sponsor ID
- pamukkaleU
- Conditions
- Stroke
- Keywords
- Stroke, Kinesiological Taping, Walking, Tibialis Anterior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Istanbul Rumeli UniversityUniversity, hospital or other
- Collaborators
- Pamukkale University
- Study start
- 14 Jun 2018 (actual)
- Primary completion
- 22 Jul 2019 (actual)
- Study completion
- 5 May 2020 (actual)
- First posted
- 11 Jun 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.
The effect of kinesiological taping applied to the tibialis anterior muscle on gait parameter in stroke patients: Sham controlled study
Detailed description
Objective: The aim of this study was to compare the immediate effect of kinesiological and / or sham taping to the tibialis anterior muscle on walking parameters in stroke individuals.
Methods: The study included 28 adults stroke patients . The subjects who received scores of 7 or more in the Hodkinson Mental Test and 3 and above in the Functional Ambulation Classification with subjects who gastrocnemius muscle spasticity 2 and below points according to Modified Ashworth Scale were included in the study. The walking parameters of the participants were evaluated with the BTS G-Walk Spatio-Temporal Walking Analysis System. The walking parameters of the participants who were selected by randomization method were evaluated separately by applying kinesiological taping and sham taping or without any taping or interference on a 10 meter track.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Sham Controlled Study
| Arm | Type | Receives |
|---|---|---|
| No tape applied | No intervention | –Walking parameters were evaluated without any intervention. |
| Kinesiological Tape | Experimental | Other: kinesiological tapingWalking parameters were evaluated after kinesiological taping on the tibialis anterior muscle |
| Sham taping | Sham comparator | Other: kinesiological tapingWalking parameters were evaluated after sham taping on the tibialis anterior muscle |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 28 stroke individuals (hemiplegic / hemiparetic) who were treated in the Adult
- Neurological Rehabilitation Unit of Pamukkale University Medical Faculty Hospital were included in the study.
- Being between the ages of 25-70
- Volunteers with written consent
- With a 1-year history of stroke
Key exclusion criteria (5 listed)
- Having neurological or orthopedic comorbid disease
- Patients with a gastrocnemius spasticity greater than 2 according to the modified ashworth scale
- Patients with communication problems
- Patients with cognitive functions below 7 points according to the Hodkinson Mental Test
- Patients with ambulation level below 3 according to Functional Ambulation Classification
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 |
|---|---|---|
| kinesiological tapingThe kinesiological banding applied to the tibialis anterior muscle was applied to improve walking parameters and compared to sham control. | Other | Kinesiological Tape, Sham taping |
Primary outcome
non-taping walking parameter measurement
Time frame: 2 hours
The dominant side lower extremity of the participants was determined as the first preferred lower limb to take steps when walking. Walking parameters of the participants included in the study were evaluated with BTS G-Walk Spatio-Temporal Gait Analysis System. Before the banding applications of the patients, walking parameters were measured by asking them to walk with a shoe that they always use daily with the command "walk normally" on a 10-meter course, and stop with the command "stop" after 10 meters.
2 secondary outcomes
With kinesiological taping walking parameter measurement
Time frame: 2 hours
With sham taping walking parameter measurement
Time frame: 2 hours
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 11 Jun 2020.
- Individual participant dataSharing planned: No
Related trials for Stroke
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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.
Emre Baskan, Phd study director
Pamukkale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing kinesiological taping in people with Stroke, run by Istanbul Rumeli University at 1 site in Turkey (Türkiye).
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 7 inclusion and 5 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 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
non-taping walking parameter measurement (time frame: 2 hours). 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 11 Jun 2020.