Cerebral PalsyNCT03819205
Is Kinesio Taping Treatment Effective in Children With Cerebral Palsy?
A study testing kinesiotaping in people with Cerebral Palsy, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
Cerebral palsy (CP) is defined as a non-progressive lesion of the immature brain. Children with CP may present with a variety of motor impairments. The impaired upper limb function of children with cerebral palsy (CP) limits and restricts participation in activities of daily living. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- kinesiotaping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2018to 10 Mar 2019
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age between 6-18
- Following up with diagnose of hemiplegic/diplegic/tetraplegic CP patients with current imaginig findings
- Patient with stable clinical status
- Stage ≤2 patients depended on the modified ascwort scale
- Patients who are eligible to participate the study tests with suitable cognitive state
- Patients who agreed to participate the study.
Who cannot join
- Stage >2 patients depended on the modified ascwort scale
- Botilinum toxin intervention to the upper extremity in the last 6 months.
- Patients who undergo upper extremity surgery.
- Patients who have contraindication for kinesiotaping (Wide and severe skin injury, open wounds at risk of infection , allergic reactions)
- Patients with intense sensory and motor loss in the banding area
- Patients classified in stage IIB and above according to Zancolli stage
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Dokuz Eylul University
Izmir, İ̇zmi̇r, 35340
Zeynep Tokel, MD
About this study
Official title: Investıgatıng the Effect of Kinesiotaping on Hand Functions in Children With Cerebral Palsy
Cerebral palsy (CP) is defined as a non-progressive lesion of the immature brain. Children with CP may present with a variety of motor impairments.
The impaired upper limb function of children with cerebral palsy (CP) limits and restricts participation in activities of daily living.
Kinesio Taping (KT) is commonly used in sport injuries, in neurology and oncology patients following the surgical protocols, and for pediatric rehabilitation to reduce pain, facilitate or inhibit muscle activity, prevent injuries, reposition joints, aid the lymphatic system, support postural alignment, and improve proprioception. Kinesiotaping is a treatment that has not been studied much and can be applied in cerebral palsy. The tapes were grouped as elastic and rigid. In fact, there has been a few studies that investigates the effect of upper extremity elastic kinesiotaping. High methodological studies about its efficacy in this population are rare.
Read the detailed description
34 Children with cerebral palsy aged between 6-18 applied to Dokuz Eylül Üniversity Medical School Hospital Physical Medicine ve Rehabilitation Department will be included the study. Patients have diagnosed as CP with the subgroup of diplegic, hemiplegic, tetraplegic and mixt. The upper extremity side will be chosen as the affected side for the hemiplegic CP's and for diplegic, tetraplegic CP's the side of upper extremity which children have been used to but have obstacles in daily life. The chosen upper extremity side will be taped with the functional correction technique on the dorsum of the hand and forearm by clinician. Patients will be taped at least 2-3 hours a day every day and they will be also recomended dealing with the grasping and releasing activities in daily living at about 2-3 hours a day. In a way that every patient has to be the control of themselves, 1 week before kinesiotaping, immediately after kinesiotaping and 1 week after the period of kinesiotaping patients will be evaluated with box and block test, nine hole peg test, modified house clasification score and the active/passive wrist dorsiflexion range of motion. The investigator will also note the gross motor function clasification system level, dominant hand side and affected side, for chosen upper extremity side's zancolli clasification, modified aschwort scale of wrist and hand fingers, manual ability clasification system level for every patient.
- Conditions
- Cerebral Palsy
- Being tested
- kinesiotaping
- Keywords
- cerebral palsy, upper extremity kinesiotaping, modified house
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
kinesiotapingOther
The participants will receive kinesiotaping treatment on the affected side for the hemiplegic CP's and for diplegic, tetraplegic CP's the side of upper extremity which children have been used to but have obstacles in daily life for 1 week at least 2-3 hours a day, renewing if it's necessary. The participants will be also recomended dealing with the grasping and releasing activities in daily living at about 2-3 hours a day. In a way that every patient has to be the control of themselves, 1 week before kinesiotaping, immediately after kinesiotaping and 1 week after the period of kinesiotaping, patients will be evaluated with box and block test, nine hole peg test, modified house clasification and the active/passive wrist dorsiflexion range of motion
| Study group | Role | What they receive |
|---|---|---|
| kinesiotaping group(before/after) | Experimental | * Hemiplegic CP:Kinesiotaping on the affected side
* Diplegic, tetraplegic CP: side of upper extremity which children have been used to but have obstacles in daily life
* intervention Duration: For 1 week at least 2-3 hours a day, renewing if it's necessary.
* Note:Patients will be also recomended dealing with the grasping and releasing activities in daily living at about 2-3 hours a day.
* Evaluation: In a way that every patient has to be the control of themselves, 1 week before kinesiotaping, immediately after kinesiotaping and 1 week after the period of kinesiotaping, patients will be evaluated with box and block test, nine hole peg test, modified house clasification and the active/passive wrist dorsiflexion range of motion Receives: Other: kinesiotaping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Box and block test
With the stopwatch, it is recorded how many small cubes are transferred to the other side of the box within 60 seconds.
Measured: 1 week before kinesiotaping and 1 week after the period of kinesiotaping (change form baseline will be evaluated)
Nine hole peg test
A wooden box with nine holes is placed in front of the patient and held in seconds with the stopwatch. Insersion and extraction time of pegs in second are noted.
Measured: 1 week before kinesiotaping and 1 week after the period of kinesiotaping (change form baseline will be evaluated)
Secondary outcomes (2)
Modified house clasification score
The score obtained from the Modified House Classification is calculated by recording the patient's capabilities among the listed 32 activities
Measured: 1 week before kinesiotaping and 1 week after the period of kinesiotaping (change form baseline will be evaluated)
Active/passive wrist dorsiflexion range of motion
With goniometer active/passive wrist dorsiflexion range of motion will be measured.
Measured: 1 week before kinesiotaping and 1 week after the period of kinesiotaping (change form baseline will be evaluated)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start15 Apr 2018
- Primary completion10 Mar 2019 (estimated)
- Study completion10 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies 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
- self-controlled study
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ZEYNEP TOKEL, Dokuz Eylul University
- Investigators
- Zeynep Tokel, MD, Principal investigator, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03819205
- Sponsor's protocol ID
- DorkuzEUZTOKEL
- Status last verified
- Jan 2019
- First submitted
- 23 Jan 2019
- Last updated
- 29 Jan 2019
- 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 29 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investıgatıng the Effect of Kinesiotaping on Hand Functions in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT03819205
- Acronym / sponsor ID
- DorkuzEUZTOKEL
- Conditions
- Cerebral Palsy
- Keywords
- cerebral palsy, upper extremity kinesiotaping, modified house
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 15 Apr 2018 (actual)
- Primary completion
- 10 Mar 2019 (estimated)
- Study completion
- 10 Mar 2019 (estimated)
- First posted
- 28 Jan 2019 (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.
Cerebral palsy (CP) is defined as a non-progressive lesion of the immature brain. Children with CP may present with a variety of motor impairments.
The impaired upper limb function of children with cerebral palsy (CP) limits and restricts participation in activities of daily living.
Kinesio Taping (KT) is commonly used in sport injuries, in neurology and oncology patients following the surgical protocols, and for pediatric rehabilitation to reduce pain, facilitate or inhibit muscle activity, prevent injuries, reposition joints, aid the lymphatic system, support postural alignment, and improve proprioception. Kinesiotaping is a treatment that has not been studied much and can be applied in cerebral palsy. The tapes were grouped as elastic and rigid. In fact, there has been a few studies that investigates the effect of upper extremity elastic kinesiotaping. High methodological studies about its efficacy in this population are rare.
Detailed description
34 Children with cerebral palsy aged between 6-18 applied to Dokuz Eylül Üniversity Medical School Hospital Physical Medicine ve Rehabilitation Department will be included the study. Patients have diagnosed as CP with the subgroup of diplegic, hemiplegic, tetraplegic and mixt. The upper extremity side will be chosen as the affected side for the hemiplegic CP's and for diplegic, tetraplegic CP's the side of upper extremity which children have been used to but have obstacles in daily life. The chosen upper extremity side will be taped with the functional correction technique on the dorsum of the hand and forearm by clinician. Patients will be taped at least 2-3 hours a day every day and they will be also recomended dealing with the grasping and releasing activities in daily living at about 2-3 hours a day. In a way that every patient has to be the control of themselves, 1 week before kinesiotaping, immediately after kinesiotaping and 1 week after the period of kinesiotaping patients will be evaluated with box and block test, nine hole peg test, modified house clasification score and the active/passive wrist dorsiflexion range of motion. The investigator will also note the gross motor function clasification system level, dominant hand side and affected side, for chosen upper extremity side's zancolli clasification, modified aschwort scale of wrist and hand fingers, manual ability clasification system level for every patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- self-controlled study
| Arm | Type | Receives |
|---|---|---|
| kinesiotaping group(before/after) | Experimental | Other: kinesiotaping* Hemiplegic CP:Kinesiotaping on the affected side * Diplegic, tetraplegic CP: side of upper extremity which children have been used to but have obstacles in daily life * intervention Duration: For 1 week at least 2-3 hours a day, renewing if it's necessary. * Note:Patients will be also recomended dealing with the grasping and releasing activities in daily living at about 2-3 hours a day. * Evaluation: In a way that every patient has to be the control of themselves, 1 week before kinesiotaping, immediately after kinesiotaping and 1 week after the period of kinesiotaping, patients will be evaluated with box and block test, nine hole peg test, modified house clasification and the active/passive wrist dorsiflexion range of motion |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Age between 6-18
- Following up with diagnose of hemiplegic/diplegic/tetraplegic CP patients with current imaginig findings
- Patient with stable clinical status
- Stage ≤2 patients depended on the modified ascwort scale
- Patients who are eligible to participate the study tests with suitable cognitive state
Key exclusion criteria (6 listed)
- Stage >2 patients depended on the modified ascwort scale
- Botilinum toxin intervention to the upper extremity in the last 6 months.
- Patients who undergo upper extremity surgery.
- Patients who have contraindication for kinesiotaping (Wide and severe skin injury, open wounds at risk of infection , allergic reactions)
- Patients with intense sensory and motor loss in the banding area
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 |
|---|---|---|
| kinesiotapingThe participants will receive kinesiotaping treatment on the affected side for the hemiplegic CP's and for diplegic, tetraplegic CP's the side of upper extremity which children have been used to but have obstacles in daily life for 1 week at least 2-3 hours a day, renewing if it's necessary. The participants will be also recomended dealing with the grasping and releasing activities in daily living at about 2-3 hours a day. In a way that every patient has to be the control of themselves, 1 week before kinesiotaping, immediately after kinesiotaping and 1 week after the period of kinesiotaping, patients will be evaluated with box and block test, nine hole peg test, modified house clasification and the active/passive wrist dorsiflexion range of motion | Other | kinesiotaping group(before/after) |
Primary outcome
Box and block test
Time frame: 1 week before kinesiotaping and 1 week after the period of kinesiotaping (change form baseline will be evaluated)
With the stopwatch, it is recorded how many small cubes are transferred to the other side of the box within 60 seconds.
Nine hole peg test
Time frame: 1 week before kinesiotaping and 1 week after the period of kinesiotaping (change form baseline will be evaluated)
A wooden box with nine holes is placed in front of the patient and held in seconds with the stopwatch. Insersion and extraction time of pegs in second are noted.
2 secondary outcomes
Modified house clasification score
Time frame: 1 week before kinesiotaping and 1 week after the period of kinesiotaping (change form baseline will be evaluated)
Active/passive wrist dorsiflexion range of motion
Time frame: 1 week before kinesiotaping and 1 week after the period of kinesiotaping (change form baseline will be evaluated)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2019.
- Individual participant dataSharing planned: No
Related trials for Cerebral Palsy
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Recruiting
Additional Effects on tDCS With AOT on Lower Limb Functions on Children With Diplegic CP
Diplegic Cerebral Palsy
Recruiting
Sensory Integration Therapy vs Conventional Physical Therapy in Children With Mixed Cerebral Palsy
Cerebral Palsy
Active, not recruiting
Functional Outcomes and Control Using Synchron BCI - Australia
Neurologic Disorder, Neurologic Diseases
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
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.
Zeynep Tokel, MD principal investigator
Dokuz Eylul 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 kinesiotaping in people with Cerebral Palsy, run by Dokuz Eylul 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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 29 Jan 2019. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zeynep Tokel (+905068535386, zeyneptkl343@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Box and block test (time frame: 1 week before kinesiotaping and 1 week after the period of kinesiotaping (change form baseline will be evaluated)). The study lists 2 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 29 Jan 2019.