Juvenile Idiopathic ArthritisNCT06356350
Exercise Programs on Gait in Children JIA
A study testing Conventional neuromuscular exercises and Core based exercises in people with Juvenile Idiopathic Arthritis and Gait, Frontal, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Juvenile Idiopathic Arthritis (JIA) is one of the common chronic diseases in childhood. Problems such as weakness or pain may occur in JIA, especially in the joints and the muscles around the trunk. Read more about this study
- Who is it for?
- Ages 8 to 16 years
- Conditions the study is for
- Juvenile Idiopathic Arthritis, Gait, Frontal
- What is being tested?
- Conventional neuromuscular exercises and Core based exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2024to 10 Nov 2024
- 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 8 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Having a diagnosis of oligoarticular JIA
- Being between the age of 8 and 16
- Having included knee joint.
Who cannot join
- Having an additional neurological or orthopedic diagnosis other than JIA Affecting treatment results,
- Having had any surgery on the spine or the extremity joints
- Being at a level that will not understand the questions asked.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Exercise Programs on Gait in Children With Juvenile Idiopathic Arthritis
Juvenile Idiopathic Arthritis (JIA) is one of the common chronic diseases in childhood. Problems such as weakness or pain may occur in JIA, especially in the joints and the muscles around the trunk. These conditions may lead to abnormal displacement of the center of gravity, deterioration of biomechanics, and muscle imbalance in children with JIA. All these situations can lead to postural imbalance and asymmetrical loading pattern, which we often encounter in children with JIA. Current studies describing various exercise methods effective on postural alignment. However, no study was found in the literature that searching the effects of these exercise methods on gait parameters in children JIA.
Read the detailed description
Juvenile Idiopathic Arthritis (JIA) is one of the common chronic diseases in childhood. Problems such as weakness or pain may occur in JIA, especially in the joints and the muscles around the trunk. These conditions may lead to abnormal displacement of the center of gravity, deterioration of biomechanics, and muscle imbalance in children with JIA. These conditions may lead to abnormal displacement of the center of gravity, deterioration of biomechanics, and muscle imbalance in children with JIA. All these situations can lead to postural imbalance and asymmetrical loading pattern, which we often encounter in children with JIA. Current studies describing various exercise methods effective on postural alignment. However, no study was found in the literature that searching the effects of these exercise methods on gait parameters in children JIA. Therefore, this study aimed to investigate the effects of two different exercise programs (core based exercise program against neuromuscular training) on gait parameters in children JIA.
In this study, the participants will be evaluated and then they will be divided into two groups randomly. The first group will be administered as a core based exercise program group and the second one will be undergone as a neuromuscular training group. After the interventions, they will be re-evaluted by the physiotherapist and the outcomes will be recorded.
- Conditions
- Juvenile Idiopathic Arthritis, Gait, Frontal
- Being tested
- Conventional neuromuscular exercises, Core based exercises
- Keywords
- juvenile idiopathic arthritis, gait, exercise, physiotherapy
- Medical subject headings
- Arthritis, Juvenile, Gait Disorders, Neurologic, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional neuromuscular exercisesOther
Conventional neuromuscular exercises represent a contemporary physiotherapeutic approach. These exercises aim to improve neuromuscular control, strength, and endurance in various muscles surrounding the included joint, contributing to the correction and maintenance of proper posture.
Core based exercisesOther
Core based exercises increase overall mobility, relieve pain, improve posture, and support spinal alignment. Especially important for children who are still growing is to slow or stop the progression of deformities because of the asymmetrical loading pattern.
| Study group | Role | What they receive |
|---|---|---|
| Core based exercise group | Active comparator | This group will be undergone core based exercises program Receives: Other: Core based exercises |
| Neuromuscular exercises group | Active comparator | This group will be undergone conventional neuromuscular exercises program Receives: Other: Conventional neuromuscular exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Loading
It will be obtained using the FreeMed baropodometry platform (the FreeStep v. 1.0. 3 88 software, Sensor Medica, Guidonia Montecelio, Roma, Italy). The unit of the outcome is per cent.
Measured: immediately after intervention
Center of mass displacement
It will be obtained using the FreeMed baropodometry platform (the FreeStep v. 1.0. 3 88 software, Sensor Medica, Guidonia Montecelio, Roma, Italy). The unit of the outcome is milimeter.
Measured: immediately after intervention
Walking speed
It will be obtained using the FreeMed baropodometry platform (the FreeStep v. 1.0. 3 88 software, Sensor Medica, Guidonia Montecelio, Roma, Italy). The unit of the outcome ia meter/second.
Measured: immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start1 Apr 2024
- Primary completion1 Nov 2024
- Study completion10 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Juvenile Idiopathic ArthritisStudies 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gokce Leblebici, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06356350
- Sponsor's protocol ID
- IUC_jia_gait
- Status last verified
- Nov 2024
- First submitted
- 4 Apr 2024
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ombrello MJ, Arthur VL, Remmers EF, Hinks A, Tachmazidou I, Grom AA, Foell D, Martini A, Gattorno M, Ozen S, Prahalad S, Zeft AS, Bohnsack JF, Ilowite NT, Mellins ED, Russo R, Len C, Hilario MO, Oliveira S, Yeung RS, Rosenberg AM, Wedderburn LR, Anton J, Haas JP, Rosen-Wolff A, Minden K, Tenbrock K, Demirkaya E, Cobb J, Baskin E, Signa S, Shuldiner E, Duerr RH, Achkar JP, Kamboh MI, Kaufman KM, Kottyan LC, Pinto D, Scherer SW, Alarcon-Riquelme ME, Docampo E, Estivill X, Gul A; British Society of Pediatric and Adolescent Rheumatology (BSPAR) Study Group, Inception Cohort of Newly Diagnosed Patients with Juvenile Idiopathic Arthritis (ICON-JIA) Study Group, Childhood Arthritis Prospective Study (CAPS) Group, Randomized Placebo Phase Study of Rilonacept in sJIA (RAPPORT) Investigators, Sparks-Childhood Arthritis Response to Medication Study (CHARMS) Group, Biologically Based Outcome Predictors in JIA (BBOP) Group; Langefeld CD, Thompson S, Zeggini E, Kastner DL, Woo P, Thomson W. Genetic architecture distinguishes systemic juvenile idiopathic arthritis from other forms of juvenile idiopathic arthritis: clinical and therapeutic implications. Ann Rheum Dis. 2017 May;76(5):906-913. doi: 10.1136/annrheumdis-2016-210324. Epub 2016 Dec 7.
PubMed 27927641Tokuda K, Anan M, Takahashi M, Sawada T, Tanimoto K, Kito N, Shinkoda K. Biomechanical mechanism of lateral trunk lean gait for knee osteoarthritis patients. J Biomech. 2018 Jan 3;66:10-17. doi: 10.1016/j.jbiomech.2017.10.016. Epub 2017 Nov 4.
PubMed 29150344Ringold S, Wallace CA, Rivara FP. Health-related quality of life, physical function, fatigue, and disease activity in children with established polyarticular juvenile idiopathic arthritis. J Rheumatol. 2009 Jun;36(6):1330-6. doi: 10.3899/jrheum.081028. Epub 2009 May 1.
PubMed 19411394KISA, E. P., & OTMAN, A. S. (2020). Skolyoz odaklı egzersizler-yedi büyük okulun kapsamlı incelemesi. Süleyman Demirel Üniversitesi Sağlık Bilimleri Dergisi, 11(2), 255-259.
Horng J, Liu XC, Thometz J, Tassone C, Duey-Holtz A. Evaluation of plantar pressures and center of pressure trajectories in Adolescent Idiopathic Scoliosis. Stud Health Technol Inform. 2021 Jun 28;280:131-135. doi: 10.3233/SHTI210451.
PubMed 34190074Gao CC, Chern JS, Chang CJ, Lai PL, Lung CW. Center of pressure progression patterns during level walking in adolescents with idiopathic scoliosis. PLoS One. 2019 Apr 22;14(4):e0212161. doi: 10.1371/journal.pone.0212161. eCollection 2019.
PubMed 31009471Zhu F, Hong Q, Guo X, Wang D, Chen J, Zhu Q, Zhang C, Chen W, Zhang M. A comparison of foot posture and walking performance in patients with mild, moderate, and severe adolescent idiopathic scoliosis. PLoS One. 2021 May 17;16(5):e0251592. doi: 10.1371/journal.pone.0251592. eCollection 2021.
PubMed 33999943
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exercise Programs on Gait in Children With Juvenile Idiopathic Arthritis
- ClinicalTrials.gov ID
- NCT06356350
- Acronym / sponsor ID
- IUC_jia_gait
- Conditions
- Juvenile Idiopathic Arthritis, Gait, Frontal
- Keywords
- juvenile idiopathic arthritis, gait, exercise, physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 10 Nov 2024 (actual)
- First posted
- 10 Apr 2024 (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.
Juvenile Idiopathic Arthritis (JIA) is one of the common chronic diseases in childhood. Problems such as weakness or pain may occur in JIA, especially in the joints and the muscles around the trunk. These conditions may lead to abnormal displacement of the center of gravity, deterioration of biomechanics, and muscle imbalance in children with JIA. All these situations can lead to postural imbalance and asymmetrical loading pattern, which we often encounter in children with JIA. Current studies describing various exercise methods effective on postural alignment. However, no study was found in the literature that searching the effects of these exercise methods on gait parameters in children JIA.
Detailed description
Juvenile Idiopathic Arthritis (JIA) is one of the common chronic diseases in childhood. Problems such as weakness or pain may occur in JIA, especially in the joints and the muscles around the trunk. These conditions may lead to abnormal displacement of the center of gravity, deterioration of biomechanics, and muscle imbalance in children with JIA. These conditions may lead to abnormal displacement of the center of gravity, deterioration of biomechanics, and muscle imbalance in children with JIA. All these situations can lead to postural imbalance and asymmetrical loading pattern, which we often encounter in children with JIA. Current studies describing various exercise methods effective on postural alignment. However, no study was found in the literature that searching the effects of these exercise methods on gait parameters in children JIA. Therefore, this study aimed to investigate the effects of two different exercise programs (core based exercise program against neuromuscular training) on gait parameters in children JIA.
In this study, the participants will be evaluated and then they will be divided into two groups randomly. The first group will be administered as a core based exercise program group and the second one will be undergone as a neuromuscular training group. After the interventions, they will be re-evaluted by the physiotherapist and the outcomes will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Core based exercise group | Active comparator | Other: Core based exercisesThis group will be undergone core based exercises program |
| Neuromuscular exercises group | Active comparator | Other: Conventional neuromuscular exercisesThis group will be undergone conventional neuromuscular exercises program |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Having a diagnosis of oligoarticular JIA
- Being between the age of 8 and 16
- Having included knee joint.
Key exclusion criteria (3 listed)
- Having an additional neurological or orthopedic diagnosis other than JIA Affecting treatment results,
- Having had any surgery on the spine or the extremity joints
- Being at a level that will not understand the questions asked.
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 |
|---|---|---|
| Conventional neuromuscular exercisesConventional neuromuscular exercises represent a contemporary physiotherapeutic approach. These exercises aim to improve neuromuscular control, strength, and endurance in various muscles surrounding the included joint, contributing to the correction and maintenance of proper posture. | Other | Neuromuscular exercises group |
| Core based exercisesCore based exercises increase overall mobility, relieve pain, improve posture, and support spinal alignment. Especially important for children who are still growing is to slow or stop the progression of deformities because of the asymmetrical loading pattern. | Other | Core based exercise group |
Primary outcome
Maximum Loading
Time frame: immediately after intervention
It will be obtained using the FreeMed baropodometry platform (the FreeStep v. 1.0. 3 88 software, Sensor Medica, Guidonia Montecelio, Roma, Italy). The unit of the outcome is per cent.
Center of mass displacement
Time frame: immediately after intervention
It will be obtained using the FreeMed baropodometry platform (the FreeStep v. 1.0. 3 88 software, Sensor Medica, Guidonia Montecelio, Roma, Italy). The unit of the outcome is milimeter.
Walking speed
Time frame: immediately after intervention
It will be obtained using the FreeMed baropodometry platform (the FreeStep v. 1.0. 3 88 software, Sensor Medica, Guidonia Montecelio, Roma, Italy). The unit of the outcome ia meter/second.
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 Nov 2024.
- Background: PubMed 27927641Ombrello MJ, Arthur VL, Remmers EF, Hinks A, Tachmazidou I, Grom AA, Foell D, Martini A, Gattorno M, Ozen S, Prahalad S, Zeft AS, Bohnsack JF, Ilowite NT, Mellins ED, Russo R, Len C, Hilario MO, Oliveira S, Yeung RS, Rosenberg AM, Wedderburn LR, Anton J, Haas JP, Rosen-Wolff A, Minden K, Tenbrock K, Demirkaya E, Cobb J, Baskin E, Signa S, Shuldiner E, Duerr RH, Achkar JP, Kamboh MI, Kaufman KM, Kottyan LC, Pinto D, Scherer SW, Alarcon-Riquelme ME, Docampo E, Estivill X, Gul A; British Society of Pediatric and Adolescent Rheumatology (BSPAR) Study Group, Inception Cohort of Newly Diagnosed Patients with Juvenile Idiopathic Arthritis (ICON-JIA) Study Group, Childhood Arthritis Prospective Study (CAPS) Group, Randomized Placebo Phase Study of Rilonacept in sJIA (RAPPORT) Investigators, Sparks-Childhood Arthritis Response to Medication Study (CHARMS) Group, Biologically Based Outcome Predictors in JIA (BBOP) Group; Langefeld CD, Thompson S, Zeggini E, Kastner DL, Woo P, Thomson W. Genetic architecture distinguishes systemic juvenile idiopathic arthritis from other forms of juvenile idiopathic arthritis: clinical and therapeutic implications. Ann Rheum Dis. 2017 May;76(5):906-913. doi: 10.1136/annrheumdis-2016-210324. Epub 2016 Dec 7.
- Background: PubMed 29150344Tokuda K, Anan M, Takahashi M, Sawada T, Tanimoto K, Kito N, Shinkoda K. Biomechanical mechanism of lateral trunk lean gait for knee osteoarthritis patients. J Biomech. 2018 Jan 3;66:10-17. doi: 10.1016/j.jbiomech.2017.10.016. Epub 2017 Nov 4.
- Background: PubMed 19411394Ringold S, Wallace CA, Rivara FP. Health-related quality of life, physical function, fatigue, and disease activity in children with established polyarticular juvenile idiopathic arthritis. J Rheumatol. 2009 Jun;36(6):1330-6. doi: 10.3899/jrheum.081028. Epub 2009 May 1.
- BackgroundKISA, E. P., & OTMAN, A. S. (2020). Skolyoz odaklı egzersizler-yedi büyük okulun kapsamlı incelemesi. Süleyman Demirel Üniversitesi Sağlık Bilimleri Dergisi, 11(2), 255-259.
- Background: PubMed 34190074Horng J, Liu XC, Thometz J, Tassone C, Duey-Holtz A. Evaluation of plantar pressures and center of pressure trajectories in Adolescent Idiopathic Scoliosis. Stud Health Technol Inform. 2021 Jun 28;280:131-135. doi: 10.3233/SHTI210451.
- Background: PubMed 31009471Gao CC, Chern JS, Chang CJ, Lai PL, Lung CW. Center of pressure progression patterns during level walking in adolescents with idiopathic scoliosis. PLoS One. 2019 Apr 22;14(4):e0212161. doi: 10.1371/journal.pone.0212161. eCollection 2019.
- Background: PubMed 33999943Zhu F, Hong Q, Guo X, Wang D, Chen J, Zhu Q, Zhang C, Chen W, Zhang M. A comparison of foot posture and walking performance in patients with mild, moderate, and severe adolescent idiopathic scoliosis. PLoS One. 2021 May 17;16(5):e0251592. doi: 10.1371/journal.pone.0251592. eCollection 2021.
- 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 Conventional neuromuscular exercises and Core based exercises in people with Juvenile Idiopathic Arthritis and Gait, Frontal, run by Istanbul University - Cerrahpasa 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 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 15 Nov 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 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?
Maximum Loading (time frame: immediately after intervention). 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?
On the ClinicalTrials.gov record for NCT06356350, which also lists 7 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 15 Nov 2024.