Cerebral PalsyNCT04351464
Is Reflexology Applied to Children With Cerebral Palsy an Effective Method?
A study testing physical therapy and reflexology in people with Cerebral Palsy and Reflexology, run by Kırıkkale University at 1 site in Turkey (Türkiye).
Trial summary
Objectives: This study was planned to investigate the influence of reflexology applied to children with cerebral palsy together with physical therapy program involving neurodevelopmental approaches. Methods: The study involved 40 children aged,16 girls and 24 boys between 3 and 15 years and divided into two groups. Read more about this study
- Who is it for?
- Ages 3 to 15 years
- Conditions the study is for
- Cerebral Palsy, Reflexology
- What is being tested?
- physical therapy and reflexology
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2014to 1 Jan 2015
- 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 3 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children at levels 3/4/5 of the GMFCS who did not have any open wounds on the foot, where the application was to be performed, and whose parents consented to the child's participation were accepted in the study.
Who cannot join
- who were treated with botulinum toxin in the last six months, underwent surgery, were treated with reflexology or any other alternative medicine method and who had refractory epilepsy.
Trial locations and contacts
1 site in 1 country.
About this study
Objectives: This study was planned to investigate the influence of reflexology applied to children with cerebral palsy together with physical therapy program involving neurodevelopmental approaches.
Methods: The study involved 40 children aged,16 girls and 24 boys between 3 and 15 years and divided into two groups. While the children in Group 1 were given twice a week for eight weeks neurodevelopmental treatment, reflexology was applied to those in Group 2 together with neurodevelopmental treatment. Drooling Severity and Frequency Scale, Pediatric Sleep Questionnaire and the Children's Health Questionnaire was used to assess the drooling, status of sleep and quality of life in children.
Read the detailed description
The study involved a total of 40 children aged between three and 15 diagnosed with CP by a pediatric neurologist. Children at levels 3/4/5 of the GMFCS who did not have any open wounds on the foot, where the application was to be performed, and whose parents consented to the child's participation were accepted in the study. However, those children were excluded who were treated with botulinum toxin in the last six months, underwent surgery, were treated with reflexology or any other alternative medicine method and who had refractory epilepsy.
- Conditions
- Cerebral Palsy, Reflexology
- Being tested
- physical therapy and reflexology
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical therapy and reflexologyOther
| Study group | Role | What they receive |
|---|---|---|
| Physical therapy and Reflexology group | Active comparator | Received reflexology implementation for 20-30 minutes on the sole along with the physical treatment involving NDT approaches. Within the scope of the implementation, all the reflex points on the sole were stimulated. The pituitary gland, which is related to sleep and control of salivation, oromotor area and areas of muscular and skeletal system were stimulated with further repetitions. Receives: Other: physical therapy and reflexology |
| Just Physical therapy group | Experimental | The group received a 45-minute physical therapy program involving NDT approaches as the control group. Within the scope of this program, the children were treated with intramuscular stretching and soft tissue mobilization, exercises that improved balance and that supported the development of postural control, position shifts, and stretching and reinforcement exercises in the necessary muscle groups. Receives: Other: physical therapy and reflexology |
What is being measured
The primary outcome is the main question the study is designed to answer.
physiological parameter
Drooling frequency and severity of drooling
Measured: 8 weeks
Questionnaire about Sleep status
Assess the problems related to sleep
Measured: 8 weeks
Questionnaire about Quality of life of children
general health, physical condition, global behavior, mental health, self-esteem and the effect of time on parents
Measured: 8 weeks
Secondary outcomes (1)
Physical parameter
weight and height will be combined to report BMI in kg/m^2
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2020
- Study start1 Jan 2014
- Primary completion1 Jan 2015
- Study completion1 Jan 2015
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
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kırıkkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sabiha BEZGİN, Kırıkkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04351464
- Sponsor's protocol ID
- SBEZGIN
- Status last verified
- Apr 2020
- First submitted
- 10 Apr 2020
- Last updated
- 17 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Reflexology Applied to Children With Cerebral Palsy an Effective Method?
- ClinicalTrials.gov ID
- NCT04351464
- Acronym / sponsor ID
- SBEZGIN
- Conditions
- Cerebral Palsy, Reflexology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Kırıkkale UniversityUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 1 Jan 2015 (actual)
- Study completion
- 1 Jan 2015 (actual)
- First posted
- 17 Apr 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.
Objectives: This study was planned to investigate the influence of reflexology applied to children with cerebral palsy together with physical therapy program involving neurodevelopmental approaches.
Methods: The study involved 40 children aged,16 girls and 24 boys between 3 and 15 years and divided into two groups. While the children in Group 1 were given twice a week for eight weeks neurodevelopmental treatment, reflexology was applied to those in Group 2 together with neurodevelopmental treatment. Drooling Severity and Frequency Scale, Pediatric Sleep Questionnaire and the Children's Health Questionnaire was used to assess the drooling, status of sleep and quality of life in children.
Detailed description
The study involved a total of 40 children aged between three and 15 diagnosed with CP by a pediatric neurologist. Children at levels 3/4/5 of the GMFCS who did not have any open wounds on the foot, where the application was to be performed, and whose parents consented to the child's participation were accepted in the study. However, those children were excluded who were treated with botulinum toxin in the last six months, underwent surgery, were treated with reflexology or any other alternative medicine method and who had refractory epilepsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical therapy and Reflexology group | Active comparator | Other: physical therapy and reflexologyReceived reflexology implementation for 20-30 minutes on the sole along with the physical treatment involving NDT approaches. Within the scope of the implementation, all the reflex points on the sole were stimulated. The pituitary gland, which is related to sleep and control of salivation, oromotor area and areas of muscular and skeletal system were stimulated with further repetitions. |
| Just Physical therapy group | Experimental | Other: physical therapy and reflexologyThe group received a 45-minute physical therapy program involving NDT approaches as the control group. Within the scope of this program, the children were treated with intramuscular stretching and soft tissue mobilization, exercises that improved balance and that supported the development of postural control, position shifts, and stretching and reinforcement exercises in the necessary muscle groups. |
Who may qualify
- Ages
- 3 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children at levels 3/4/5 of the GMFCS who did not have any open wounds on the foot, where the application was to be performed, and whose parents consented to the child's participation were accepted in the study.
Key exclusion criteria (1 listed)
- who were treated with botulinum toxin in the last six months, underwent surgery, were treated with reflexology or any other alternative medicine method and who had refractory epilepsy.
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 |
|---|---|---|
| physical therapy and reflexology | Other | Just Physical therapy group, Physical therapy and Reflexology group |
Primary outcome
physiological parameter
Time frame: 8 weeks
Drooling frequency and severity of drooling
Questionnaire about Sleep status
Time frame: 8 weeks
Assess the problems related to sleep
Questionnaire about Quality of life of children
Time frame: 8 weeks
general health, physical condition, global behavior, mental health, self-esteem and the effect of time on parents
1 secondary outcome
Physical parameter
Time frame: 8 weeks
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 17 Apr 2020.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physical therapy and reflexology in people with Cerebral Palsy and Reflexology, run by Kırıkkale 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 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 17 Apr 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. 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?
physiological parameter (time frame: 8 weeks). 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 17 Apr 2020.