Cerebral PalsyKT-SIT_CPNCT04991623
Short-term Effects Kinesiology Tape on Sitting Postural Control in Moderate and Severe Cerebral Palsy
A study testing Kinesiology taping and Conventional physiotherapy in people with Cerebral Palsy and Kinesiology Taping, run by University of Castilla-La Mancha at 1 site in Spain.
Trial summary
To analyze the short-term effect of kinesiology taping on sitting postural control in moderate and severe cerebral palsy Read more about this study
- Who is it for?
- Ages 4 to 14 years
- Conditions the study is for
- Cerebral Palsy, Kinesiology Taping, Postural Control
- What is being tested?
- Kinesiology taping and Conventional physiotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSpain
- Study dates
- 15 Mar 2020to 30 Jul 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 4 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- age between 4 and 14 years
- diagnosis of motor and cognitive disability
- have prescribed physiotherapy treatment at school
- acquisition of autonomous sitting
- sign the consent informed
Who cannot join
- presentation of an allergic reaction to tape
- presentation of wounds in the area of application of the tape
- having received botulinum toxin treatment in the last 6 months
Trial locations and contacts
1 site in 1 country.
About this study
To analyze the short-term effect of kinesiology taping on sitting postural control in moderate and severe cerebral palsy
- Conditions
- Cerebral Palsy, Kinesiology Taping, Postural Control
- Being tested
- Kinesiology taping, Conventional physiotherapy
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesiology tapingDevice
We used kinesiology taping in abdominal muscles
Conventional physiotherapyOther
We used conventional physiotherapy to comparate
| Study group | Role | What they receive |
|---|---|---|
| Kinesiology taping | Experimental | Apply a kinesiology taping on the abdominal muscles plus conventional physiotherapy Receives: Device: Kinesiology taping |
| Physiotherapy Group | Active comparator | Apply a conventional physiotherapy Receives: Other: Conventional physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Posture and Postural Ability Scale - T0
Posture and Postural Ability Scale pre-intervention (PPAS pre). Score from 0 to 7, and the higher the score, the better posture
Measured: pre-intervention
Posture and Postural Ability Scale - T1
Posture and Postural Ability Scale post-intervention (PPAS post). Score from 0 to 7, and the higher the score, the better posture
Measured: at 10 days
Segmental Assessment of Trunk Control - T0
Segmental Assessment of Trunk Control pre-intervention (SATco pre). Score from 1 to 7, and the lower the score, the better balance
Measured: pre-intervention
Segmental Assessment of Trunk Control - T1
Segmental Assessment of Trunk Control post-intervention (SATco post).Score from 1 to 7, and the lower the score, the better balance
Measured: at 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start15 Mar 2020
- Primary completion15 Jul 2020
- Study completion30 Jul 2020
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Castilla-La Mancha
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Javier Merino Andrés, MSc, Principal investigator, Researcher
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04991623
- Sponsor's protocol ID
- jma003
- Acronym
- KT-SIT_CP
- Status last verified
- May 2024
- First submitted
- 21 Jul 2021
- Last updated
- 3 Jun 2024
- 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 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Effects Kinesiology Tape on Sitting Postural Control in Moderate and Severe Cerebral Palsy
- ClinicalTrials.gov ID
- NCT04991623
- Acronym / sponsor ID
- KT-SIT_CP / jma003
- Conditions
- Cerebral Palsy, Kinesiology Taping, Postural Control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of Castilla-La ManchaUniversity, hospital or other
- Study start
- 15 Mar 2020 (actual)
- Primary completion
- 15 Jul 2020 (actual)
- Study completion
- 30 Jul 2020 (actual)
- First posted
- 5 Aug 2021 (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 analyze the short-term effect of kinesiology taping on sitting postural control in moderate and severe cerebral palsy
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kinesiology taping | Experimental | Device: Kinesiology tapingApply a kinesiology taping on the abdominal muscles plus conventional physiotherapy |
| Physiotherapy Group | Active comparator | Other: Conventional physiotherapyApply a conventional physiotherapy |
Who may qualify
- Ages
- 4 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- age between 4 and 14 years
- diagnosis of motor and cognitive disability
- have prescribed physiotherapy treatment at school
- acquisition of autonomous sitting
- sign the consent informed
Key exclusion criteria (3 listed)
- presentation of an allergic reaction to tape
- presentation of wounds in the area of application of the tape
- having received botulinum toxin treatment in the last 6 months
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 |
|---|---|---|
| Kinesiology tapingWe used kinesiology taping in abdominal muscles | Device | Kinesiology taping |
| Conventional physiotherapyWe used conventional physiotherapy to comparate | Other | Physiotherapy Group |
Primary outcome
Posture and Postural Ability Scale - T0
Time frame: pre-intervention
Posture and Postural Ability Scale pre-intervention (PPAS pre). Score from 0 to 7, and the higher the score, the better posture
Posture and Postural Ability Scale - T1
Time frame: at 10 days
Posture and Postural Ability Scale post-intervention (PPAS post). Score from 0 to 7, and the higher the score, the better posture
Segmental Assessment of Trunk Control - T0
Time frame: pre-intervention
Segmental Assessment of Trunk Control pre-intervention (SATco pre). Score from 1 to 7, and the lower the score, the better balance
Segmental Assessment of Trunk Control - T1
Time frame: at 10 days
Segmental Assessment of Trunk Control post-intervention (SATco post).Score from 1 to 7, and the lower the score, the better balance
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 3 Jun 2024.
- 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.
Javier Merino Andrés, MSc principal investigator
Researcher
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesiology taping and Conventional physiotherapy in people with Cerebral Palsy and Kinesiology Taping, run by University of Castilla-La Mancha at 1 site in Spain.
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 3 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 3 Jun 2024. 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 Spain. 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?
Posture and Postural Ability Scale - T0 (time frame: pre-intervention). The study lists 4 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 3 Jun 2024.