Cerebral PalsyNCT05818839
Biomechanical Properties and Their Association With Balance and Functional Mobility in Children With Cerebral Palsy
An observational study of Cerebral Palsy, run by Ilke KARA at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to investigate the differences in the biomechanical properties of the dorsal trunk and lower extremity muscles of children with unilateral spastic cerebral palsy compared with their typically developing peers, and the effect of these biomechanical properties on balance and functional mobility… Read more about this study
- Who is it for?
- Ages 4 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2022to 20 Feb 2023
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children diagnosed with unilateral spastic cerebral palsy (GMFCS level I-II, spasticity level MAS ≤ 2) and their age-matched typically developing peers.
Who may be able to join
- aged between 4 and 12 years,
- no neurological or orthopaedic diagnosis,
- no known systemic problems,
- normal vision and hearing,
- and a mental level sufficient to understand the commands given.
Who cannot join
- a history of spinal surgery or spinal orthosis use,
- uncorrected vision or hearing problems,
- severe epileptic seizures,
- lower extremity contractures,
- botulinum toxin A injection in the previous six months,
- lower extremity surgery in less than one year,
- use of pharmacological agents that affect muscle tone,
- and poor cooperation.
Trial locations and contacts
1 site in 1 country.
About this study
This study aimed to investigate the differences in the biomechanical properties of the dorsal trunk and lower extremity muscles of children with unilateral spastic cerebral palsy compared with their typically developing peers, and the effect of these biomechanical properties on balance and functional mobility performance.
- Conditions
- Cerebral Palsy
- Keywords
- postural balance, muscle properties, mobility, paralysis, children
- Medical subject headings
- Cerebral Palsy, Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| UCP | Children diagnosed with unilateral spastic cerebral palsy | |
| TyD | Typically developing children |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Pediatric Balance Scale
The Pediatric Balance Scale assesses functional balance in three categories: self-care, mobility and social function, using 14 items. Each item is scored from 0 (indicating low function) to 4 (indicating highest function), with a maximum score of 56 points. A higher score indicates better balance.
Measured: Baseline
Trunk Control Measurement Scale
The TCSM was used to assess seated trunk balance and consisted of 15 items. Each item was scored from 0 to 3, with 0 indicating inability to perform the task and 3 indicating the full performance of the item. A high score indicated good trunk control
Measured: Baseline
2-Minute Walk Test
The children were asked to walk at a normal pace, without running, and the distance they walked for 2 minutes was recorded.
Measured: Baseline
Timed Up and Go Test
The children were seated with their feet in full contact with the floor, in a chair with back support only, and with their hip and knee joints at 90 degrees. On the start command, they were asked to walk 3 metres to the wall at a pace they felt comfortable with and then sit back down in the chair.
Measured: Baseline
Muscle tone (Hz)
The muscle tone which is a biomechanical property of the muscles evaluated with a portable hand-held myotonometer. This myotonometer (MyotonPRO - Tallinn, Estonia) is non-invasive and provides a quantitative assessment of a muscle's biomechanical properties. The MyotonPRO applies a short-intensity mechanical impulse on the skin overlying the muscle or facia. The tissue's response then generates a signal that is recorded, and an internal software program produces an acceleration graph.
Measured: Baseline
Stiffness (N/m)
The stiffness which is a biomechanical property of muscles will be evaluated with a portable hand-held myotonometer. This myotonometer (MyotonPRO - Tallinn, Estonia) is non-invasive and provides a quantitative assessment of a muscle's biomechanical properties. The MyotonPRO applies a short-intensity mechanical impulse on the skin overlying the muscle or facia. The tissue's response then generates a signal that is recorded, and an internal software program produces an acceleration graph.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start1 Jul 2022
- Primary completion20 Nov 2022
- Study completion20 Feb 2023
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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Ilke KARA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ilke KARA, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05818839
- Sponsor's protocol ID
- BEU-CP-01
- Status last verified
- Apr 2023
- First submitted
- 6 Apr 2023
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomechanical Properties and Their Association With Balance and Functional Mobility in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05818839
- Acronym / sponsor ID
- BEU-CP-01
- Conditions
- Cerebral Palsy
- Keywords
- postural balance, muscle properties, mobility, paralysis, children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ilke KARAUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 20 Nov 2022 (actual)
- Study completion
- 20 Feb 2023 (actual)
- First posted
- 19 Apr 2023 (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.
This study aimed to investigate the differences in the biomechanical properties of the dorsal trunk and lower extremity muscles of children with unilateral spastic cerebral palsy compared with their typically developing peers, and the effect of these biomechanical properties on balance and functional mobility performance.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UCP | – | –Children diagnosed with unilateral spastic cerebral palsy |
| TyD | – | –Typically developing children |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children diagnosed with unilateral spastic cerebral palsy (GMFCS level I-II, spasticity level MAS ≤ 2) and their age-matched typically developing peers.
Key inclusion criteria (5 listed)
- aged between 4 and 12 years,
- no neurological or orthopaedic diagnosis,
- no known systemic problems,
- normal vision and hearing,
- and a mental level sufficient to understand the commands given.
Key exclusion criteria (8 listed)
- a history of spinal surgery or spinal orthosis use,
- uncorrected vision or hearing problems,
- severe epileptic seizures,
- lower extremity contractures,
- botulinum toxin A injection in the previous six months,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The Pediatric Balance Scale
Time frame: Baseline
The Pediatric Balance Scale assesses functional balance in three categories: self-care, mobility and social function, using 14 items. Each item is scored from 0 (indicating low function) to 4 (indicating highest function), with a maximum score of 56 points. A higher score indicates better balance.
Trunk Control Measurement Scale
Time frame: Baseline
The TCSM was used to assess seated trunk balance and consisted of 15 items. Each item was scored from 0 to 3, with 0 indicating inability to perform the task and 3 indicating the full performance of the item. A high score indicated good trunk control
2-Minute Walk Test
Time frame: Baseline
The children were asked to walk at a normal pace, without running, and the distance they walked for 2 minutes was recorded.
Timed Up and Go Test
Time frame: Baseline
The children were seated with their feet in full contact with the floor, in a chair with back support only, and with their hip and knee joints at 90 degrees. On the start command, they were asked to walk 3 metres to the wall at a pace they felt comfortable with and then sit back down in the chair.
Muscle tone (Hz)
Time frame: Baseline
The muscle tone which is a biomechanical property of the muscles evaluated with a portable hand-held myotonometer. This myotonometer (MyotonPRO - Tallinn, Estonia) is non-invasive and provides a quantitative assessment of a muscle's biomechanical properties. The MyotonPRO applies a short-intensity mechanical impulse on the skin overlying the muscle or facia. The tissue's response then generates a signal that is recorded, and an internal software program produces an acceleration graph.
Stiffness (N/m)
Time frame: Baseline
The stiffness which is a biomechanical property of muscles will be evaluated with a portable hand-held myotonometer. This myotonometer (MyotonPRO - Tallinn, Estonia) is non-invasive and provides a quantitative assessment of a muscle's biomechanical properties. The MyotonPRO applies a short-intensity mechanical impulse on the skin overlying the muscle or facia. The tissue's response then generates a signal that is recorded, and an internal software program produces an acceleration graph.
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 19 Apr 2023.
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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?
An observational study of Cerebral Palsy, run by Ilke KARA 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 5 inclusion and 8 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 19 Apr 2023. 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?
The Pediatric Balance Scale (time frame: Baseline). The study lists 6 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 19 Apr 2023.