Range of MotionNCT06510933
Stability Effects After Heel Cups Orthopedics Treatment in Different BMI
A study testing Heel cups in different BMI index and its correlation to physical activity in children in people with Range of Motion, run by Universidad Miguel Hernandez de Elche at 1 site in Spain.
Trial summary
Actual research relates Body mass Index (BMI) with postural changes in children and musculoskeletal disorders during growing period. BMI is widely used by clinicians and researchers due to easily capacity of application and scale classification patients in relation to their weight, the scale presents underweight… Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Range of Motion
- What is being tested?
- Heel cups in different BMI index and its correlation to physical activity in children
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteSpain
- Study dates
- 7 Jan 2024to 30 Jul 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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children 8-12 years old
- Regular sports practice
- Decreased range of flexión
Who cannot join
- Having neurological, vestibular, muscular, psychological or visual visual disease.
- Traumatic pathology 12 months prior to the measurement (sprains, talalgias, etc.).
- Diseases of balance or motor control.
- Surgeries in the last 12 months.
- Taking medications that may affect the neuromuscular system.
- Sports practice in the last 48 hours.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stability Effects After Heel Cups Orthopedics Treatment in Different BMI Index and Its Correlation to Physical Activity in Children. A Longitudinal Intervention Study
Actual research relates Body mass Index (BMI) with postural changes in children and musculoskeletal disorders during growing period. BMI is widely used by clinicians and researchers due to easily capacity of application and scale classification patients in relation to their weight, the scale presents underweight, normal weight, overweight and obesity stages.
In paediatric context, underweight or overweight body mass in children negatively influences their posture, even in his adult life. Children with overweight and obesity shows less stability, and develop worse postural control, one of the demonstrated effects are the column alignment alteration and other bones structures. Elevated BMI are related to high differences in postural control, to elevated risk of pain, hypertension and musculoskeletal disorders. Underweight BMI is associated to less muscular mass and fat body composition, that are necessary to a correct posture, and contributes to increase probability of injuries.
Read more
The maintaining balance engages three systems, i.e., the vestibular system, vision, and proprioception. Some authors consider that postural stability develops between the ages 8 to 9. There are also papers arguing that the locomotor and postural model in 7-year-olds is similar to adults. Nevertheless, with new experiences and skills, it is possible to continue the development of all elements engaged in postural control, and keeping correct posture in children up to the age of 12 A good balance level and postural control is important in sport practice, to get high competition level efficiency in daily activities, and of course, in the clinic practice and rehabilitation.
Because of a stability loss off overweight in children, limited physical activity is established Posterior calf musculature and ankle has been shown to be involved in postural control in different studies. Likewise, the practice of physical activity induces changes in the infantile triceps suralis that generates improvements in postural control.
Currently, there are different paediatric pathologies for which heel cushions are prescribed as a treatment, such as Sever's disease leg, length discrepancy, relaxing and lenghtened calf muscles, but there is no evidence of stability effect of this treatment.
Read the detailed description
A prospective intervention study was conducted in children before and after the application of heel cushions as a treatment for calf muscle retraction in various BMI conditions in children.
The design and progression of participants through the trial was conducted in accordance with the 22 CONSORT criteria.
- Conditions
- Range of Motion
- Being tested
- Heel cups in different BMI index and its correlation to physical activity in children
- Keywords
- BALANCE, HEEL CUPS, RANGE OF MOTION, PHYSICAL ACTIVITY
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heel cups in different BMI index and its correlation to physical activity in childrenDevice
Procedure: Group with muscle retraction will use a 5 millimeter heel cups in 3 and 6 months
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator: Heel Cup in muscle retraction | Experimental | The pattern will be performed 3 times per day (10 repetitions, 30 seconds each repetition). A daily Active Comparator: Heel Cup Group The heel cup will be 5mm high (Eva Shore 65) en 3 month and 6 month. Receives: Device: Heel cups in different BMI index and its correlation to physical activity in children |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stabilometry
The measurements were conducted in the primary school of participating schools at a temperature of 22 ◦C, in the same hour of the day. To assess participants' balance, the anthropometric position of the protocol proposed by the International Society for the Advancement of Cineatropometry (ISAK) was assigned: participants placed their mi Frankfort; the upper limbs remained relaxed throughout the body, with palms facing forward and thumbs separated from the rest of the toes, and were barefoot with feet externally rotated f 30 degrees and with a heel distance of 4cm. The children were wearing sports costumes to contribute their free movement. For stabilometry data collection will use an inertial measurement instrument called Gyko® It is a state-of-the-art device that allows to measure an objective assessment of acceleration, angular velocity and with an acquisition frequency of 100Hz
Measured: pre intervention, 3 months post intervention, 6 months post intervention
heel cups in muscle retraction
Orthopaedic treatment of calf muscle retraction is defined as heel cup. A 5mm heel cup height was applied. Made of ethyl vinyl acetate material with a hard shore A 65º. The main function of a heel pad was to provide a slight change in heel elevation
Measured: Pre intervention, 3 months post intervention, 6 months post intervention.
Secondary outcomes (2)
Lunge test
To determine the dorsal flexion of the ankle, the Lunge Test was used. Through the Leg MOtion® system
Measured: Pre intervention, 3 months post intervention, 6 months post intervention.
Physical Activity Questionnaire for Children (PAQ-C)
The Spanish version of the Physical Activity Questionnaire for Children (PAQ-C) validated by Manchola- will be used to collect data on the type and amount of physical activity performed by the participants
Measured: Pre intervention, 3 months post intervention, 6 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start7 Jan 2024
- Primary completion20 Jul 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Range of MotionStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Longitudinal
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Miguel Hernandez de Elche
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vicenta Martínez Córcoles, Universidad Miguel Hernandez de Elche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06510933
- Sponsor's protocol ID
- UCV/2017-2018/113
- Status last verified
- Sep 2024
- First submitted
- 8 Jul 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
D Hondt E, Deforche B, De Bourdeaudhuij I, Lenoir M. Relationship between motor skill and body mass index in 5- to 10-year-old children. Adapt Phys Activ Q. 2009 Jan;26(1):21-37. doi: 10.1123/apaq.26.1.21.
PubMed 19246771D'Hondt E, Deforche B, De Bourdeaudhuij I, Gentier I, Tanghe A, Shultz S, Lenoir M. Postural balance under normal and altered sensory conditions in normal-weight and overweight children. Clin Biomech (Bristol). 2011 Jan;26(1):84-9. doi: 10.1016/j.clinbiomech.2010.08.007. Epub 2010 Sep 17.
PubMed 20850213Hermassi S, Ketelhut S, Konukman F, Ayari MA, Al-Marri S, Al Rawahi N, Bouhafs EG, Nigg CR, Schwesig R. Differences in Physical Activity, Sedentary Behavior, Health-Related Physical Performance Indices and Academic Achievement: A Comparative Study of Normal-Weight and Obese Children in Qatar. J Clin Med. 2024 Feb 13;13(4):1057. doi: 10.3390/jcm13041057.
PubMed 38398370Hommen JM, Batista JP, Bollheimer LC, Hildebrand F, Laurentius T, Siebers HL. Movement patterns during gait initiation in older adults with various stages of frailty: a biomechanical analysis. Eur Rev Aging Phys Act. 2024 Jan 13;21(1):1. doi: 10.1186/s11556-024-00335-w.
PubMed 38218828Barros WMA, da Silva KG, Silva RKP, Souza APDS, da Silva ABJ, Silva MRM, Fernandes MSS, de Souza SL, Souza VON. Effects of Overweight/Obesity on Motor Performance in Children: A Systematic Review. Front Endocrinol (Lausanne). 2022 Jan 20;12:759165. doi: 10.3389/fendo.2021.759165. eCollection 2021.
PubMed 35126307Pfeiffer M, Kotz R, Ledl T, Hauser G, Sluga M. Prevalence of flat foot in preschool-aged children. Pediatrics. 2006 Aug;118(2):634-9. doi: 10.1542/peds.2005-2126.
PubMed 16882817Nantel J, Mathieu ME, Prince F. Physical activity and obesity: biomechanical and physiological key concepts. J Obes. 2011;2011:650230. doi: 10.1155/2011/650230. Epub 2010 Nov 22.
PubMed 21113311Duncan MJ, Stanley M. Functional movement is negatively associated with weight status and positively associated with physical activity in british primary school children. J Obes. 2012;2012:697563. doi: 10.1155/2012/697563. Epub 2012 Mar 26.
PubMed 22545208Duncan MJ, Nevill A, Woodfield L, Al-Nakeeb Y. The relationship between pedometer-determined physical activity, body mass index and lean body mass index in children. Int J Pediatr Obes. 2010 Oct;5(5):445-50. doi: 10.3109/17477160903568421.
PubMed 20233151Mitchell UH, Johnson AW, Adamson B. Relationship between functional movement screen scores, core strength, posture, and body mass index in school children in Moldova. J Strength Cond Res. 2015 May;29(5):1172-9. doi: 10.1519/JSC.0000000000000722.
PubMed 25719919Martinez-Corcoles V, Nieto-Gil P, Ramos-Petersen L, Ferrer-Torregrosa J. Balance performance analysis after the COVID-19 quarantine in children aged between 8 and 12 years old: Longitudinal study. Gait Posture. 2022 May;94:203-209. doi: 10.1016/j.gaitpost.2022.03.019. Epub 2022 Mar 27.
PubMed 35366430
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stability Effects After Heel Cups Orthopedics Treatment in Different BMI Index and Its Correlation to Physical Activity in Children. A Longitudinal Intervention Study
- ClinicalTrials.gov ID
- NCT06510933
- Acronym / sponsor ID
- UCV/2017-2018/113
- Conditions
- Range of Motion
- Keywords
- BALANCE, HEEL CUPS, RANGE OF MOTION, PHYSICAL ACTIVITY
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Universidad Miguel Hernandez de ElcheUniversity, hospital or other
- Study start
- 7 Jan 2024 (actual)
- Primary completion
- 20 Jul 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 19 Jul 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.
Actual research relates Body mass Index (BMI) with postural changes in children and musculoskeletal disorders during growing period. BMI is widely used by clinicians and researchers due to easily capacity of application and scale classification patients in relation to their weight, the scale presents underweight, normal weight, overweight and obesity stages.
In paediatric context, underweight or overweight body mass in children negatively influences their posture, even in his adult life. Children with overweight and obesity shows less stability, and develop worse postural control, one of the demonstrated effects are the column alignment alteration and other bones structures. Elevated BMI are related to high differences in postural control, to elevated risk of pain, hypertension and musculoskeletal disorders. Underweight BMI is associated to less muscular mass and fat body composition, that are necessary to a correct posture, and contributes to increase probability of injuries.
The maintaining balance engages three systems, i.e., the vestibular system, vision, and proprioception. Some authors consider that postural stability develops between the ages 8 to 9. There are also papers arguing that the locomotor and postural model in 7-year-olds is similar to adults. Nevertheless, with new experiences and skills, it is possible to continue the development of all elements engaged in postural control, and keeping correct posture in children up to the age of 12 A good balance level and postural control is important in sport practice, to get high competition level efficiency in daily activities, and of course, in the clinic practice and rehabilitation.
Because of a stability loss off overweight in children, limited physical activity is established Posterior calf musculature and ankle has been shown to be involved in postural control in different studies. Likewise, the practice of physical activity induces changes in the infantile triceps suralis that generates improvements in postural control.
Currently, there are different paediatric pathologies for which heel cushions are prescribed as a treatment, such as Sever's disease leg, length discrepancy, relaxing and lenghtened calf muscles, but there is no evidence of stability effect of this treatment.
Detailed description
A prospective intervention study was conducted in children before and after the application of heel cushions as a treatment for calf muscle retraction in various BMI conditions in children.
The design and progression of participants through the trial was conducted in accordance with the 22 CONSORT criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Longitudinal
| Arm | Type | Receives |
|---|---|---|
| Active Comparator: Heel Cup in muscle retraction | Experimental | Device: Heel cups in different BMI index and its correlation to physical activity in childrenThe pattern will be performed 3 times per day (10 repetitions, 30 seconds each repetition). A daily Active Comparator: Heel Cup Group The heel cup will be 5mm high (Eva Shore 65) en 3 month and 6 month. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children 8-12 years old
- Regular sports practice
- Decreased range of flexión
Key exclusion criteria (6 listed)
- Having neurological, vestibular, muscular, psychological or visual visual disease.
- Traumatic pathology 12 months prior to the measurement (sprains, talalgias, etc.).
- Diseases of balance or motor control.
- Surgeries in the last 12 months.
- Taking medications that may affect the neuromuscular system.
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 |
|---|---|---|
| Heel cups in different BMI index and its correlation to physical activity in childrenProcedure: Group with muscle retraction will use a 5 millimeter heel cups in 3 and 6 months | Device | Active Comparator: Heel Cup in muscle retraction |
Primary outcome
Stabilometry
Time frame: pre intervention, 3 months post intervention, 6 months post intervention
The measurements were conducted in the primary school of participating schools at a temperature of 22 ◦C, in the same hour of the day. To assess participants' balance, the anthropometric position of the protocol proposed by the International Society for the Advancement of Cineatropometry (ISAK) was assigned: participants placed their mi Frankfort; the upper limbs remained relaxed throughout the body, with palms facing forward and thumbs separated from the rest of the toes, and were barefoot with feet externally rotated f 30 degrees and with a heel distance of 4cm. The children were wearing sports costumes to contribute their free movement. For stabilometry data collection will use an inertial measurement instrument called Gyko® It is a state-of-the-art device that allows to measure an objective assessment of acceleration, angular velocity and with an acquisition frequency of 100Hz
heel cups in muscle retraction
Time frame: Pre intervention, 3 months post intervention, 6 months post intervention.
Orthopaedic treatment of calf muscle retraction is defined as heel cup. A 5mm heel cup height was applied. Made of ethyl vinyl acetate material with a hard shore A 65º. The main function of a heel pad was to provide a slight change in heel elevation
2 secondary outcomes
Lunge test
Time frame: Pre intervention, 3 months post intervention, 6 months post intervention.
Physical Activity Questionnaire for Children (PAQ-C)
Time frame: Pre intervention, 3 months post intervention, 6 months post intervention
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 Sep 2024.
- Results publication: PubMed 19246771D Hondt E, Deforche B, De Bourdeaudhuij I, Lenoir M. Relationship between motor skill and body mass index in 5- to 10-year-old children. Adapt Phys Activ Q. 2009 Jan;26(1):21-37. doi: 10.1123/apaq.26.1.21.
- Results publication: PubMed 20850213D'Hondt E, Deforche B, De Bourdeaudhuij I, Gentier I, Tanghe A, Shultz S, Lenoir M. Postural balance under normal and altered sensory conditions in normal-weight and overweight children. Clin Biomech (Bristol). 2011 Jan;26(1):84-9. doi: 10.1016/j.clinbiomech.2010.08.007. Epub 2010 Sep 17.
- Results publication: PubMed 38398370Hermassi S, Ketelhut S, Konukman F, Ayari MA, Al-Marri S, Al Rawahi N, Bouhafs EG, Nigg CR, Schwesig R. Differences in Physical Activity, Sedentary Behavior, Health-Related Physical Performance Indices and Academic Achievement: A Comparative Study of Normal-Weight and Obese Children in Qatar. J Clin Med. 2024 Feb 13;13(4):1057. doi: 10.3390/jcm13041057.
- Results publication: PubMed 38218828Hommen JM, Batista JP, Bollheimer LC, Hildebrand F, Laurentius T, Siebers HL. Movement patterns during gait initiation in older adults with various stages of frailty: a biomechanical analysis. Eur Rev Aging Phys Act. 2024 Jan 13;21(1):1. doi: 10.1186/s11556-024-00335-w.
- Results publication: PubMed 35126307Barros WMA, da Silva KG, Silva RKP, Souza APDS, da Silva ABJ, Silva MRM, Fernandes MSS, de Souza SL, Souza VON. Effects of Overweight/Obesity on Motor Performance in Children: A Systematic Review. Front Endocrinol (Lausanne). 2022 Jan 20;12:759165. doi: 10.3389/fendo.2021.759165. eCollection 2021.
- Results publication: PubMed 16882817Pfeiffer M, Kotz R, Ledl T, Hauser G, Sluga M. Prevalence of flat foot in preschool-aged children. Pediatrics. 2006 Aug;118(2):634-9. doi: 10.1542/peds.2005-2126.
- Results publication: PubMed 21113311Nantel J, Mathieu ME, Prince F. Physical activity and obesity: biomechanical and physiological key concepts. J Obes. 2011;2011:650230. doi: 10.1155/2011/650230. Epub 2010 Nov 22.
- Results publication: PubMed 22545208Duncan MJ, Stanley M. Functional movement is negatively associated with weight status and positively associated with physical activity in british primary school children. J Obes. 2012;2012:697563. doi: 10.1155/2012/697563. Epub 2012 Mar 26.
- Results publication: PubMed 20233151Duncan MJ, Nevill A, Woodfield L, Al-Nakeeb Y. The relationship between pedometer-determined physical activity, body mass index and lean body mass index in children. Int J Pediatr Obes. 2010 Oct;5(5):445-50. doi: 10.3109/17477160903568421.
- Results publication: PubMed 25719919Mitchell UH, Johnson AW, Adamson B. Relationship between functional movement screen scores, core strength, posture, and body mass index in school children in Moldova. J Strength Cond Res. 2015 May;29(5):1172-9. doi: 10.1519/JSC.0000000000000722.
- Results publication: PubMed 35366430Martinez-Corcoles V, Nieto-Gil P, Ramos-Petersen L, Ferrer-Torregrosa J. Balance performance analysis after the COVID-19 quarantine in children aged between 8 and 12 years old: Longitudinal study. Gait Posture. 2022 May;94:203-209. doi: 10.1016/j.gaitpost.2022.03.019. Epub 2022 Mar 27.
- 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 Heel cups in different BMI index and its correlation to physical activity in children in people with Range of Motion, run by Universidad Miguel Hernandez de Elche 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 3 inclusion and 6 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 Sep 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?
Stabilometry (time frame: pre intervention, 3 months post intervention, 6 months post intervention). 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?
On the ClinicalTrials.gov record for NCT06510933, which also lists 11 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 19 Sep 2024.