Effectiveness of Manual Therapy in the Treatment of Attention Deficit Hyperactivity Disorder
NCT ID: NCT07029425
Last Updated: 2025-06-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
60 participants
INTERVENTIONAL
2025-10-01
2026-06-30
Brief Summary
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Detailed Description
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Materials and Methods: A randomized clinical trial will be conducted. The minimum sample size required for statistical significance is 60 subjects, divided into two groups with 30 participants each. The primary variable will be hyperactivity and attention deficit, assessed using the Conners Parent Rating Scale and the Conners Teacher Rating Scale. The secondary variable will be mood, measured using a facial expression scale.
Objetives To determine whether the addition of manual therapy to conventional treatment is more effective in improving ADHD symptoms than conventional treatment alone.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Experimental: craniosacral therapy techniques.
Experimental:
Participants in the experimental group will receive Manual Therapy (MT) designed for this study, which will include craniosacral therapy techniques. The sessions will last 40 minutes and will be conducted twice a week for the first 4 weeks, followed by once a week for the final 4 weeks.
Procedure: craniosacral therapy techniques.
Participants in the experimental group will receive Manual Therapy (MT) designed for this study, which will include craniosacral therapy techniques. The sessions will last 40 minutes and will be conducted twice a week for the first 4 weeks, followed by once a week for the final 4 weeks.
Control: placebo comparator.
Sham Comparator:
The placebo group will receive a dummy treatment with a duration of 40min, twice a week for the firt 4 week, follwed by once a week for the final 4 week.
Placebo Group
The placebo group will receive a dummy treatment with a duration of 40min, twice a week for the firt 4 week, follwed by once a week for the final 4 week.
Interventions
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Procedure: craniosacral therapy techniques.
Participants in the experimental group will receive Manual Therapy (MT) designed for this study, which will include craniosacral therapy techniques. The sessions will last 40 minutes and will be conducted twice a week for the first 4 weeks, followed by once a week for the final 4 weeks.
Placebo Group
The placebo group will receive a dummy treatment with a duration of 40min, twice a week for the firt 4 week, follwed by once a week for the final 4 week.
Eligibility Criteria
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Inclusion Criteria
* Children and adolescents aged 6 to 12 years.
* Availability to attend all Manual Therapy (MT) sessions.
* Informed consent signed by legal guardians.
Exclusion Criteria
* Medical conditions that contraindicate MT (e.g., fractures, severe scoliosis, connective tissue diseases).
* Recent use of or changes in ADHD medication within the past 4 weeks.
* Simultaneous participation in other interventional studies.
6 Years
12 Years
ALL
No
Sponsors
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JJ JIMENEZ-REJANO
OTHER
Responsible Party
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JJ JIMENEZ-REJANO
Director
Locations
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Grupo de Investigación Área de Fisioterapia CTS 305 - Universidad de Sevilla, Sevilla, Spain 41009
Alcalá de Henares, Madrid, Spain
Countries
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Central Contacts
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Facility Contacts
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References
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Chan SKC, Zhang D, Bogels SM, Chan CS, Lai KYC, Lo HHM, Yip BHK, Lau ENS, Gao TT, Wong SYS. Effects of a mindfulness-based intervention (MYmind) for children with ADHD and their parents: protocol for a randomised controlled trial. BMJ Open. 2018 Nov 12;8(11):e022514. doi: 10.1136/bmjopen-2018-022514.
Accorsi A, Lucci C, Di Mattia L, Granchelli C, Barlafante G, Fini F, Pizzolorusso G, Cerritelli F, Pincherle M. Effect of osteopathic manipulative therapy in the attentive performance of children with attention-deficit/hyperactivity disorder. J Am Osteopath Assoc. 2014 May;114(5):374-81. doi: 10.7556/jaoa.2014.074.
Danckaerts M, Sonuga-Barke EJ, Banaschewski T, Buitelaar J, Dopfner M, Hollis C, Santosh P, Rothenberger A, Sergeant J, Steinhausen HC, Taylor E, Zuddas A, Coghill D. The quality of life of children with attention deficit/hyperactivity disorder: a systematic review. Eur Child Adolesc Psychiatry. 2010 Feb;19(2):83-105. doi: 10.1007/s00787-009-0046-3. Epub 2009 Jul 26.
Crouzet L, Gramond A, Suehs C, Fabbro-Peray P, Abbar M, Lopez-Castroman J. Third-generation cognitive behavioral therapy versus treatment-as-usual for attention deficit and hyperactivity disorder: a multicenter randomized controlled trial. Trials. 2022 Jan 28;23(1):83. doi: 10.1186/s13063-021-05983-2.
Bellato A, Arora I, Hollis C, Groom MJ. Is autonomic nervous system function atypical in attention deficit hyperactivity disorder (ADHD)? A systematic review of the evidence. Neurosci Biobehav Rev. 2020 Jan;108:182-206. doi: 10.1016/j.neubiorev.2019.11.001. Epub 2019 Nov 10.
Polanczyk G, de Lima MS, Horta BL, Biederman J, Rohde LA. The worldwide prevalence of ADHD: a systematic review and metaregression analysis. Am J Psychiatry. 2007 Jun;164(6):942-8. doi: 10.1176/ajp.2007.164.6.942.
Robertz AC, Tornhage CJ, Nilsson S, Nyman V, Kantzer AK. Positive effects of tactile massage for adolescents with Attention Deficit/Hyperactivity Disorder (ADHD) - A small scale study. Complement Ther Clin Pract. 2024 Nov;57:101909. doi: 10.1016/j.ctcp.2024.101909. Epub 2024 Sep 25.
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Steinau S. Diagnostic Criteria in Attention Deficit Hyperactivity Disorder - Changes in DSM 5. Front Psychiatry. 2013 May 30;4:49. doi: 10.3389/fpsyt.2013.00049. eCollection 2013. No abstract available.
Pumprla J, Howorka K, Groves D, Chester M, Nolan J. Functional assessment of heart rate variability: physiological basis and practical applications. Int J Cardiol. 2002 Jul;84(1):1-14. doi: 10.1016/s0167-5273(02)00057-8.
Rechberger V, Biberschick M, Porthun J. Effectiveness of an osteopathic treatment on the autonomic nervous system: a systematic review of the literature. Eur J Med Res. 2019 Oct 25;24(1):36. doi: 10.1186/s40001-019-0394-5.
Mizuno Y, Cai W, Supekar K, Makita K, Takiguchi S, Tomoda A, Menon V. Methylphenidate remediates aberrant brain network dynamics in children with attention-deficit/hyperactivity disorder: A randomized controlled trial. Neuroimage. 2022 Aug 15;257:119332. doi: 10.1016/j.neuroimage.2022.119332. Epub 2022 May 28.
Haugan AJ, Sund AM, Young S, Thomsen PH, Lydersen S, Novik TS. Cognitive behavioural group therapy as addition to psychoeducation and pharmacological treatment for adolescents with ADHD symptoms and related impairments: a randomised controlled trial. BMC Psychiatry. 2022 Jun 2;22(1):375. doi: 10.1186/s12888-022-04019-6.
Cai W, Mizuno Y, Tomoda A, Menon V. Bayesian dynamical system analysis of the effects of methylphenidate in children with attention-deficit/hyperactivity disorder: a randomized trial. Neuropsychopharmacology. 2023 Oct;48(11):1690-1698. doi: 10.1038/s41386-023-01668-3. Epub 2023 Jul 25.
Cade A, Jones K, Holt K, Penkar AM, Haavik H. The Effects of Spinal Manipulation on Oculomotor Control in Children with Attention Deficit Hyperactivity Disorder: A Pilot and Feasibility Study. Brain Sci. 2021 Aug 6;11(8):1047. doi: 10.3390/brainsci11081047.
Bayo-Tallon V, Esquirol-Caussa J, Pamias-Massana M, Planells-Keller K, Palao-Vidal DJ. Effects of manual cranial therapy on heart rate variability in children without associated disorders: Translation to clinical practice. Complement Ther Clin Pract. 2019 Aug;36:125-141. doi: 10.1016/j.ctcp.2019.06.008. Epub 2019 Jul 2.
LeBaron S, Zeltzer L. Assessment of acute pain and anxiety in children and adolescents by self-reports, observer reports, and a behavior checklist. J Consult Clin Psychol. 1984 Oct;52(5):729-38. doi: 10.1037//0022-006x.52.5.729. No abstract available.
Pan MR, Dong M, Zhang SY, Liu L, Li HM, Wang YF, Qian QJ. One-year follow-up of the effectiveness and mediators of cognitive behavioural therapy among adults with attention-deficit/hyperactivity disorder: secondary outcomes of a randomised controlled trial. BMC Psychiatry. 2024 Mar 16;24(1):207. doi: 10.1186/s12888-024-05673-8.
Zhu C. Effects of Musicotherapy Combined with Cognitive Behavioral Intervention on the Cognitive Ability of Children with Attention Deficit Hyperactivity Disorder. Psychiatr Danub. 2022 Summer;34(2):288-295. doi: 10.24869/psyd.2022.288.
Other Identifiers
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USeville-PFB
Identifier Type: -
Identifier Source: org_study_id
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