Hemiplegic Cerebral PalsyNCT05238259
Kinesiotaping Versus Wrist Wheel on Upper Extremity Functions in Children With Hemiparetic Cerebral Palsy
A study testing kinesiotaping and wrist wheel in people with Hemiplegic Cerebral Palsy, run by Cairo University at 1 site in Egypt.
Trial summary
Investigate the effect of wrist wheel exercise on ROM of forearm supination and its reflection on upper extremity functions of children with HCP and Compare between effects of kinesiotaping and wrist wheel on ROM of forearm supination and its reflection on upper extremity functions of children with HCP Read more about this study
- Who is it for?
- Ages 6 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemiplegic Cerebral Palsy
- What is being tested?
- kinesiotaping and wrist wheel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2021to Mar 2022
- 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 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age ranged from six to eight years.
- Diagnosed as HCP.
- Children with mild upper limb spasticity in all upper limb muscles (grades 1 to 1+) according to modified Ashworth scale.
- Children had impaired hand functions level II and III according to Manual Ability Classification System.
- They had the ability to follow simple verbal commands regarding assessment and treatment
Who cannot join
- Sever visual or auditory problems
- Children with severe sensory at the affected upper limb.
- Recent orthopedic surgical interference in the affected upper limb in the last six months before the study (Tenotomy or muscle transfer in the affected upper limb)
- Recent botulinum toxin injection of the affected upper extremity muscles in the last six months before the study.
Trial locations and contacts
1 site in 1 country.
Manal Salah contact
Egypt1 site, 1 recruiting
- Recruiting
Mohamed Abd Elfatah abd El karim Ibrahim
Cairo
manal salah
About this study
Investigate the effect of wrist wheel exercise on ROM of forearm supination and its reflection on upper extremity functions of children with HCP and Compare between effects of kinesiotaping and wrist wheel on ROM of forearm supination and its reflection on upper extremity functions of children with HCP
Read the detailed description
Hemiparetic CP affects one side of the body, typically with marked involvement of the upper extremity, and is associated with reduced selective motor control and limited forearm supination . Hemiparetic child has a significant reduction of the effective use of the arm and hand in ADL (e.g. drinking, eating, accomplishing self-care, combing hair or dressing), and their participation at home, school, and later vocational roles .
Finding a therapeutic modality to improve ROM of forearm supination is an issue of concern in this study as a child uses varying degrees of supination throughout the day to complete simple activities. Some tasks only involve a person to use half of their supination ROM (e.g: clapping hands together) while other activities require a person to supinate through their full ROM (e.g: carrying a lunch tray). Hemiparetic child has limited supination movement, therefore this study will be conducted to investigate and compare between the therapeutic outcomes of kinesiotaping and wrist wheel on ROM of forearm supination which is important for upper extremity functions of the children with HCP.
- Conditions
- Hemiplegic Cerebral Palsy
- Being tested
- kinesiotaping, wrist wheel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
kinesiotapingDevice
Kinesio tape is the name of an adhesive tape created by Kenzo Kase in Japan in 1973. Kinesiotaping is latex-free with 100% cotton fibers that has no pharmaceutical effect, designed to mimic the elasticity properties of the muscle, skin, and fascia. These properties make it resistant and wearable for a long period, in general, 3 to 5 days at a time; it is even water resistant.
wrist wheelDevice
Wrist wheel is a therapy aid that exercises muscles in the wrist, forearm and shoulder. It utilizes exercises known as pronation and supination moving from pronation to supination exercises is made easy because of the wheel. It allows the pateint to easily roll wrist back and forth focusing on the wrist and arm
| Study group | Role | What they receive |
|---|---|---|
| kinesiotaping | Other | Kinesio tape is the name of an adhesive tape created by Kenzo Kase in Japan in 1973. Kinesiotaping is latex-free with 100% cotton fibers that has no pharmaceutical effect, designed to mimic the elasticity properties of the muscle, skin, and fascia. These properties make it resistant and wearable for a long period, in general, 3 to 5 days at a time; it is even water resistant. Receives: Device: kinesiotaping |
| wrist wheel | Other | Wrist wheel is a therapy aid that exercises muscles in the wrist, forearm and shoulder. It utilizes exercises known as pronation and supination moving from pronation to supination exercises is made easy because of the wheel. It allows the patient to easily roll wrist back and forth focusing on the wrist and arm Receives: Device: wrist wheel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Digital Goniometer used to measure range of motion of forearm supination in Children with Hemiparetic Cerebral Palsy.
48 children from both genders participated in this study.They assessed by Digital Goniometer to measure range of motion of forearm supination in Children with Hemiparetic Cerebral Palsy.They selected by Modified Ashworth Scale to rate muscle spasticity that all subjects selected in this study are graded 1 to 1+ for affected upper limb muscles and Manual Ability Classification System that all subjects selected in this study level II and III .
Measured: baseline
Shriners Hospital Upper Extremity Evaluation (SHUEE) used to evaluate the spontaneous use of the involved extremity and evaluate the segmental alignment of the extremity while performing tasks on demand in Children with Hemiparetic Cerebral Palsy.
48 children from both genders participated in this study.They assessed by Shriners Hospital Upper Extremity Evaluation (SHUEE) to evaluate upper extremity functions in Children with Hemiparetic Cerebral Palsy.They selected by Modified Ashworth Scale to rate muscle spasticity that all subjects selected in this study are graded 1 to 1+ for affected upper limb muscles and Manual Ability Classification System that all subjects selected in this study level II and III .
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start1 Dec 2021
- Primary completion28 Feb 2022 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hemiplegic Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health and Population, Egypt
- Responsible party
- Principal investigator, Mohamed Abd Elfatah Abd Elkarim Ibrahim, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05238259
- Sponsor's protocol ID
- KT versus Wrist wheel on Hemi
- Status last verified
- Feb 2022
- First submitted
- 2 Nov 2021
- Last updated
- 14 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Shamsoddini A, Rasti Z, Kalantari M, Hollisaz MT, Sobhani V, Dalvand H, Bakhshandeh-Bali MK. The impact of Kinesio taping technique on children with cerebral palsy. Iran J Neurol. 2016 Oct 7;15(4):219-227.
PubMed 28435631Allah RASTIl Z, Shamsoddini A, Dalvand H, Labaf S. The Effect of Kinesio Taping on Handgrip and Active Range of Motion of Hand in Children with Cerebral Palsy. Iran J Child Neurol. 2017 Fall;11(4):43-51.
PubMed 29201123
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kinesiotaping Versus Wrist Wheel on Upper Extremity Functions in Children With Hemiparetic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05238259
- Acronym / sponsor ID
- KT versus Wrist wheel on Hemi
- Conditions
- Hemiplegic Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Ministry of Health and Population, Egypt
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 28 Feb 2022 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 14 Feb 2022 (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.
Investigate the effect of wrist wheel exercise on ROM of forearm supination and its reflection on upper extremity functions of children with HCP and Compare between effects of kinesiotaping and wrist wheel on ROM of forearm supination and its reflection on upper extremity functions of children with HCP
Detailed description
Hemiparetic CP affects one side of the body, typically with marked involvement of the upper extremity, and is associated with reduced selective motor control and limited forearm supination . Hemiparetic child has a significant reduction of the effective use of the arm and hand in ADL (e.g. drinking, eating, accomplishing self-care, combing hair or dressing), and their participation at home, school, and later vocational roles .
Finding a therapeutic modality to improve ROM of forearm supination is an issue of concern in this study as a child uses varying degrees of supination throughout the day to complete simple activities. Some tasks only involve a person to use half of their supination ROM (e.g: clapping hands together) while other activities require a person to supinate through their full ROM (e.g: carrying a lunch tray). Hemiparetic child has limited supination movement, therefore this study will be conducted to investigate and compare between the therapeutic outcomes of kinesiotaping and wrist wheel on ROM of forearm supination which is important for upper extremity functions of the children with HCP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| kinesiotaping | Other | Device: kinesiotapingKinesio tape is the name of an adhesive tape created by Kenzo Kase in Japan in 1973. Kinesiotaping is latex-free with 100% cotton fibers that has no pharmaceutical effect, designed to mimic the elasticity properties of the muscle, skin, and fascia. These properties make it resistant and wearable for a long period, in general, 3 to 5 days at a time; it is even water resistant. |
| wrist wheel | Other | Device: wrist wheelWrist wheel is a therapy aid that exercises muscles in the wrist, forearm and shoulder. It utilizes exercises known as pronation and supination moving from pronation to supination exercises is made easy because of the wheel. It allows the patient to easily roll wrist back and forth focusing on the wrist and arm |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age ranged from six to eight years.
- Diagnosed as HCP.
- Children with mild upper limb spasticity in all upper limb muscles (grades 1 to 1+) according to modified Ashworth scale.
- Children had impaired hand functions level II and III according to Manual Ability Classification System.
- They had the ability to follow simple verbal commands regarding assessment and treatment
Key exclusion criteria (4 listed)
- Sever visual or auditory problems
- Children with severe sensory at the affected upper limb.
- Recent orthopedic surgical interference in the affected upper limb in the last six months before the study (Tenotomy or muscle transfer in the affected upper limb)
- Recent botulinum toxin injection of the affected upper extremity muscles in the last six months before the study.
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 |
|---|---|---|
| kinesiotapingKinesio tape is the name of an adhesive tape created by Kenzo Kase in Japan in 1973. Kinesiotaping is latex-free with 100% cotton fibers that has no pharmaceutical effect, designed to mimic the elasticity properties of the muscle, skin, and fascia. These properties make it resistant and wearable for a long period, in general, 3 to 5 days at a time; it is even water resistant. | Device | kinesiotaping |
| wrist wheelWrist wheel is a therapy aid that exercises muscles in the wrist, forearm and shoulder. It utilizes exercises known as pronation and supination moving from pronation to supination exercises is made easy because of the wheel. It allows the pateint to easily roll wrist back and forth focusing on the wrist and arm | Device | wrist wheel |
Primary outcome
Digital Goniometer used to measure range of motion of forearm supination in Children with Hemiparetic Cerebral Palsy.
Time frame: baseline
48 children from both genders participated in this study.They assessed by Digital Goniometer to measure range of motion of forearm supination in Children with Hemiparetic Cerebral Palsy.They selected by Modified Ashworth Scale to rate muscle spasticity that all subjects selected in this study are graded 1 to 1+ for affected upper limb muscles and Manual Ability Classification System that all subjects selected in this study level II and III .
Shriners Hospital Upper Extremity Evaluation (SHUEE) used to evaluate the spontaneous use of the involved extremity and evaluate the segmental alignment of the extremity while performing tasks on demand in Children with Hemiparetic Cerebral Palsy.
Time frame: baseline
48 children from both genders participated in this study.They assessed by Shriners Hospital Upper Extremity Evaluation (SHUEE) to evaluate upper extremity functions in Children with Hemiparetic Cerebral Palsy.They selected by Modified Ashworth Scale to rate muscle spasticity that all subjects selected in this study are graded 1 to 1+ for affected upper limb muscles and Manual Ability Classification System that all subjects selected in this study level II and III .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2022.
- Background: PubMed 28435631Shamsoddini A, Rasti Z, Kalantari M, Hollisaz MT, Sobhani V, Dalvand H, Bakhshandeh-Bali MK. The impact of Kinesio taping technique on children with cerebral palsy. Iran J Neurol. 2016 Oct 7;15(4):219-227.
- Background: PubMed 29201123Allah RASTIl Z, Shamsoddini A, Dalvand H, Labaf S. The Effect of Kinesio Taping on Handgrip and Active Range of Motion of Hand in Children with Cerebral Palsy. Iran J Child Neurol. 2017 Fall;11(4):43-51.
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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.
Manal Salah contact
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 and wrist wheel in people with Hemiplegic Cerebral Palsy, run by Cairo University at 1 site in Egypt.
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 5 inclusion and 4 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 14 Feb 2022. 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 Egypt. 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 Mohamed Abd Elfatah (01025140047, mohafh92@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Digital Goniometer used to measure range of motion of forearm supination in Children with Hemiparetic Cerebral Palsy. (time frame: baseline). 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?
On the ClinicalTrials.gov record for NCT05238259, which also lists 2 linked publications.
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 Feb 2022.