Spina BifidaNCT07125807
Plyometric vs Resistance Training for Trunk Balance in Children With Spina Bifida
A study testing upper extremity plyometric exercises and upper extremity resistance exercises in people with Spina Bifida and Balance Changes, run by Okan University at 1 site in Turkey (Türkiye).
Trial summary
Objective: To compare the efficacy of upper extremity plyometric and resistance exercises in improving trunk balance in children with Spina Bifida (SB). Methods: This randomized controlled trial (RCT) enrolled 28 children (aged 6-12 years) with lumbar-level SB, randomized to plyometric (n=14) or resistance (n=14)… Read more about this study
- Who is it for?
- Ages 6 to 15 years
- Conditions the study is for
- Spina Bifida, Balance Changes
- What is being tested?
- upper extremity plyometric exercises and upper extremity resistance exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2025to 30 Jul 2025
- 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 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The study included children diagnosed with lumbar-level Spina Bifida,
- Aged 6 to 15 years,
- IQ of 50 or higher based on the SPARCLE cognitive assessment
Who cannot join
- History of shunt infection or revision,
- Tethered cord syndrome or syringomyelia,
- Insufficient sitting balance,
- Upper extremity spasticity or contractures,
- Severe visual or hearing impairments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Upper Extremity Plyometric Versus Resistance Exercises to Enhance Trunk Balance in Children With Spina Bifida: A Randomized Controlled Trial
Objective: To compare the efficacy of upper extremity plyometric and resistance exercises in improving trunk balance in children with Spina Bifida (SB).
Methods: This randomized controlled trial (RCT) enrolled 28 children (aged 6-12 years) with lumbar-level SB, randomized to plyometric (n=14) or resistance (n=14) exercise groups for an 8-week intervention (3 days/week) alongside standard rehabilitation. Primary outcomes included Trunk Control Measurement Scale (TCMS) for static/dynamic sitting and reaching, and Pediatric Balance Scale (PBS) for overall balance. Secondary outcomes included ambulation levels via Hoffer classification.
Read the detailed description
Objective:
To compare the effectiveness of upper extremity plyometric versus resistance exercises in enhancing trunk balance among children with lumbar-level Spina Bifida (SB).
Methods:
This randomized controlled trial included 28 children (aged 6-12 years) diagnosed with lumbar-level SB. Participants were randomly assigned to either a plyometric exercise group (n = 14) or a resistance exercise group (n = 14). Both groups received an 8-week intervention (three sessions per week) in addition to their standard rehabilitation programs.
Primary outcomes were assessed using the Trunk Control Measurement Scale (TCMS)-evaluating static sitting, dynamic sitting, and reaching control-and the Pediatric Balance Scale (PBS) to assess overall balance capabilities. Secondary outcomes included ambulation status, measured using the Hoffer classification.
- Conditions
- Spina Bifida, Balance Changes
- Being tested
- upper extremity plyometric exercises, upper extremity resistance exercises
- Keywords
- Spina Bifida, Plyometric exercises, Sitting Balance, Pediatric Rehabilitation
- Medical subject headings
- Spinal Dysraphism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
upper extremity plyometric exercisesOther
upper extremity plyometric exercises in neuro rehabilitation
upper extremity resistance exercisesOther
upper extremity resistance exercises in neuro rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Plyometric | Experimental | plyometric exercises for trunk and sitting balance Receives: Other: upper extremity plyometric exercises |
| Resistance | Active comparator | resistance exercises for trunk and sitting balance Receives: Other: upper extremity resistance exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trunk Control Measurement Scale (TCMS)
It measures both static and dynamic trunk control, including selective motor control and dynamic reaching abilities. The total TCMS score ranges from 0 to 58 points. Higher scores on the TCMS indicate better trunk control and function.
Measured: Day 1, right before starting treatment and right after finishing the treatment (4 weeks). using questionary scores
Pediatric Balance Scale (PBS)
It is a reliable and valid clinical tool designed to assess functional balance in children aged 5 to 15 years with mild to moderate balance impairments. It is a modified version of the Berg Balance Scale tailored specifically for pediatric use, focusing on balance performance during daily functional tasks. The PBS consists of 14 items, each scored on a 5-point scale from 0 to 4: The total PBS score ranges from 0 to 56 points (14 items x 4 points each). Higher scores indicate better functional balance and motor performance.
Measured: Day 1, right before starting treatment and right after finishing the treatment (4 weeks). using questionarry scores
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start1 Mar 2025
- Primary completion20 Jul 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spina BifidaStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Okan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozgur Surenkok, Okan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07125807
- Sponsor's protocol ID
- 61351342/020-512
- Status last verified
- Aug 2025
- First submitted
- 17 Jun 2025
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- 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 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Upper Extremity Plyometric Versus Resistance Exercises to Enhance Trunk Balance in Children With Spina Bifida: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07125807
- Acronym / sponsor ID
- 61351342/020-512
- Conditions
- Spina Bifida, Balance Changes
- Keywords
- Spina Bifida, Plyometric exercises, Sitting Balance, Pediatric Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Okan UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 20 Jul 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 15 Aug 2025 (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.
Objective: To compare the efficacy of upper extremity plyometric and resistance exercises in improving trunk balance in children with Spina Bifida (SB).
Methods: This randomized controlled trial (RCT) enrolled 28 children (aged 6-12 years) with lumbar-level SB, randomized to plyometric (n=14) or resistance (n=14) exercise groups for an 8-week intervention (3 days/week) alongside standard rehabilitation. Primary outcomes included Trunk Control Measurement Scale (TCMS) for static/dynamic sitting and reaching, and Pediatric Balance Scale (PBS) for overall balance. Secondary outcomes included ambulation levels via Hoffer classification.
Detailed description
Objective:
To compare the effectiveness of upper extremity plyometric versus resistance exercises in enhancing trunk balance among children with lumbar-level Spina Bifida (SB).
Methods:
This randomized controlled trial included 28 children (aged 6-12 years) diagnosed with lumbar-level SB. Participants were randomly assigned to either a plyometric exercise group (n = 14) or a resistance exercise group (n = 14). Both groups received an 8-week intervention (three sessions per week) in addition to their standard rehabilitation programs.
Primary outcomes were assessed using the Trunk Control Measurement Scale (TCMS)-evaluating static sitting, dynamic sitting, and reaching control-and the Pediatric Balance Scale (PBS) to assess overall balance capabilities. Secondary outcomes included ambulation status, measured using the Hoffer classification.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plyometric | Experimental | Other: upper extremity plyometric exercisesplyometric exercises for trunk and sitting balance |
| Resistance | Active comparator | Other: upper extremity resistance exercisesresistance exercises for trunk and sitting balance |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- The study included children diagnosed with lumbar-level Spina Bifida,
- Aged 6 to 15 years,
- IQ of 50 or higher based on the SPARCLE cognitive assessment
Key exclusion criteria (5 listed)
- History of shunt infection or revision,
- Tethered cord syndrome or syringomyelia,
- Insufficient sitting balance,
- Upper extremity spasticity or contractures,
- Severe visual or hearing impairments
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 |
|---|---|---|
| upper extremity plyometric exercisesupper extremity plyometric exercises in neuro rehabilitation | Other | Plyometric |
| upper extremity resistance exercisesupper extremity resistance exercises in neuro rehabilitation | Other | Resistance |
Primary outcome
Trunk Control Measurement Scale (TCMS)
Time frame: Day 1, right before starting treatment and right after finishing the treatment (4 weeks). using questionary scores
It measures both static and dynamic trunk control, including selective motor control and dynamic reaching abilities. The total TCMS score ranges from 0 to 58 points. Higher scores on the TCMS indicate better trunk control and function.
Pediatric Balance Scale (PBS)
Time frame: Day 1, right before starting treatment and right after finishing the treatment (4 weeks). using questionarry scores
It is a reliable and valid clinical tool designed to assess functional balance in children aged 5 to 15 years with mild to moderate balance impairments. It is a modified version of the Berg Balance Scale tailored specifically for pediatric use, focusing on balance performance during daily functional tasks. The PBS consists of 14 items, each scored on a 5-point scale from 0 to 4: The total PBS score ranges from 0 to 56 points (14 items x 4 points each). Higher scores indicate better functional balance and motor performance.
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 15 Aug 2025.
- 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.
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 upper extremity plyometric exercises and upper extremity resistance exercises in people with Spina Bifida and Balance Changes, run by Okan 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 3 inclusion and 5 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 15 Aug 2025. 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?
Trunk Control Measurement Scale (TCMS) (time frame: Day 1, right before starting treatment and right after finishing the treatment (4 weeks). using questionary scores). 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 15 Aug 2025.