Chiropractic Care on Behavior, Neurological Function and Quality of Life in ADHD Children - A Pilot Study

NCT03849807 | Completed DMC

• 1 other identifier: RiphahIU Imran khan Niazi2
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

To date the effects of chiropractic care on behavior and neurological function in children diagnosed with ADHD has not been investigated thoroughly and is limited mostly to case studies and retrospective case reviews. Our research group recently completed a pilot study that investigated the effects of a single session of chiropractic care on oculomotor function and reading ability in children with ADHD. The findings of this study suggested that chiropractic care may have a role in improving oculomotor control and reading ability in this population group. This proposed study is the next step in this program of research and is a pilot clinical trial that will investigate whether 4 weeks of chiropractic care influences behavior, neurological function, or quality of life in children with ADHD.

Conditions

Attention Deficit Disorder With Hyperactivity

Keywords

Attention Deficit Disorder with Hyperactivity; Children; Chiropractic; Neurological function; Quality of life

Outcome Measures

Primary Outcomes (3)

• Vanderbilt Attention Deficit Hyperactivity Disorder (ADHD) Diagnostic Rating Scale

  Changes From Baseline, The Vanderbilt ADHD Diagnostic Rating Scale (VADRS) is a psychological assessment tool for Attention Deficit Hyperactivity Disorder (ADHD) symptoms and their effects on behavior and academic performance in children. It have two components: symptom assessment and impairment in performance. To meet criteria for ADHD diagnoses, one must have 6 positive responses to either the core 9 inattentive symptoms or core 9 hyperactive symptoms, or both. the respondent to rate the frequency of a child's behaviors on a 0-3 scale as follows: 0: "never"; 1: "occasionally"; 2: "often"; 3: "very often". to rate the child's performance in school and his or her interactions with others on a 1-5 scale, with 1-2 meaning "above average", 3 meaning "average", and 4-5 meaning "problematic". To meet criteria for ADHD, there must be at least one score for the performance set that is either a 4 or 5, as these scores indicate impairment in performance.

  baseline,4th week, 8th week

• Swanson, Nolan and Pelham (SNAP) Questionnaire

  Changes from the Baseline The SNAP-IV is based on a 0 to 3 rating scale: Not at All = 0, Just A Little = 1, Quite A Bit = 2, and Very Much = 3. Subscale scores on the SNAP-IV are calculated by summing the scores on the items in the subset and dividing by the number of items in the subset.

  baseline,4th week, 8th week

• ADHA Attention Deficit Hyperactivity Disorder Rating Scale IV (Home version)

  Changes from the Baseline, The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). For inattention (IA) subscale raw score: Add the odd-numbered items For hyperactivity-impulsivity (HI) subscale raw score: Add the even-numbered items. To obtain the total raw score: Add the IA and Hi subscale raw scores

  baseline,4th week, 8th week

Study Arms (2)

Experimental group

EXPERIMENTAL

Chiropractic care

Other: Experimental group

Control group

ACTIVE COMPARATOR

Usual health care

Other: Control group

Interventions

Experimental group OTHER

the intervention group will receive 4 weeks of chiropractic care along with usual care(Cognitive-Behavioral, psychosocial Therapy).

Experimental group

Control group OTHER

Participants in the group will receive usual health (Cognitive-Behavioral, psychosocial Therapy) care or wish to engage in during the course of the study as well as receiving a passive movement control intervention delivered by a chiropractor 3 times per week in the same hospital setting as the group receiving chiropractic care.

Control group

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• have been previously diagnosed with Attention Deficit Hypersensitivity Disorder based on the criteria outlined in the DSM-V.

You may not qualify if:

• have absolute contraindications to chiropractic adjustments
• have experienced previous significant adverse reactions to chiropractic care or manual therapies.
• investigators are unable to get consent from parents and caregivers of participating children in the trial

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Riphah International University

Islamabad, Federal, 44000, Pakistan

Location

Related Publications (14)

• Harpin VA. The effect of ADHD on the life of an individual, their family, and community from preschool to adult life. Arch Dis Child. 2005 Feb;90 Suppl 1(Suppl 1):i2-7. doi: 10.1136/adc.2004.059006.

  PMID: 15665153 BACKGROUND

• Munoz DP, Armstrong IT, Hampton KA, Moore KD. Altered control of visual fixation and saccadic eye movements in attention-deficit hyperactivity disorder. J Neurophysiol. 2003 Jul;90(1):503-14. doi: 10.1152/jn.00192.2003. Epub 2003 Apr 2.

  PMID: 12672781 BACKGROUND

• Sable JJ, Kyle MR, Knopf KL, Schully LT, Brooks MM, Parry KH, Diamond RE, Flink LA, Stowe R, Suna E, Thompson IA. The Sensory Gating Inventory as a potential diagnostic tool for attention-deficit hyperactivity disorder. Atten Defic Hyperact Disord. 2012 Sep;4(3):141-4. doi: 10.1007/s12402-012-0079-1. Epub 2012 May 27.

  PMID: 22644992 BACKGROUND

• Haavik H, Murphy B. The role of spinal manipulation in addressing disordered sensorimotor integration and altered motor control. J Electromyogr Kinesiol. 2012 Oct;22(5):768-76. doi: 10.1016/j.jelekin.2012.02.012. Epub 2012 Apr 6.

  PMID: 22483612 BACKGROUND

• Henderson CN. The basis for spinal manipulation: chiropractic perspective of indications and theory. J Electromyogr Kinesiol. 2012 Oct;22(5):632-42. doi: 10.1016/j.jelekin.2012.03.008. Epub 2012 Apr 17.

  PMID: 22513367 BACKGROUND

• Daligadu J, Haavik H, Yielder PC, Baarbe J, Murphy B. Alterations in cortical and cerebellar motor processing in subclinical neck pain patients following spinal manipulation. J Manipulative Physiol Ther. 2013 Oct;36(8):527-37. doi: 10.1016/j.jmpt.2013.08.003. Epub 2013 Sep 12.

  PMID: 24035521 BACKGROUND

• Holt KR, Haavik H, Lee AC, Murphy B, Elley CR. Effectiveness of Chiropractic Care to Improve Sensorimotor Function Associated With Falls Risk in Older People: A Randomized Controlled Trial. J Manipulative Physiol Ther. 2016 May;39(4):267-78. doi: 10.1016/j.jmpt.2016.02.003. Epub 2016 Apr 2.

  PMID: 27050038 BACKGROUND

• Karpouzis F, Bonello R, Pollard H. Chiropractic care for paediatric and adolescent Attention-Deficit/Hyperactivity Disorder: A systematic review. Chiropr Osteopat. 2010 Jun 2;18:13. doi: 10.1186/1746-1340-18-13.

  PMID: 20525195 BACKGROUND

• Rabe-Jablonska J. [Affective disorders in the fourth edition of the classification of mental disorders prepared by the American Psychiatric Association -- diagnostic and statistical manual of mental disorders]. Psychiatr Pol. 1993 May-Jun;27(3):269-79. No abstract available. Polish.

  PMID: 8356173 BACKGROUND

• McGough JJ, Loo SK, Sturm A, Cowen J, Leuchter AF, Cook IA. An eight-week, open-trial, pilot feasibility study of trigeminal nerve stimulation in youth with attention-deficit/hyperactivity disorder. Brain Stimul. 2015 Mar-Apr;8(2):299-304. doi: 10.1016/j.brs.2014.11.013. Epub 2014 Nov 28.

  PMID: 25533244 BACKGROUND

• Conners CK. Rating scales in attention-deficit/hyperactivity disorder: use in assessment and treatment monitoring. J Clin Psychiatry. 1998;59 Suppl 7:24-30.

  PMID: 9680050 BACKGROUND

• Childress AC, Cutler AJ, Saylor K, Gasior M, Hamdani M, Ferreira-Cornwell MC, Findling RL. Participant-perceived quality of life in a long-term, open-label trial of lisdexamfetamine dimesylate in adolescents with attention-deficit/hyperactivity disorder. J Child Adolesc Psychopharmacol. 2014 May;24(4):210-7. doi: 10.1089/cap.2013.0077. Epub 2014 May 9.

  PMID: 24815910 BACKGROUND

• Rosner AL. Evidence-based medicine: revisiting the pyramid of priorities. J Bodyw Mov Ther. 2012 Jan;16(1):42-9. doi: 10.1016/j.jbmt.2011.05.003. Epub 2011 Jun 24.

  PMID: 22196426 BACKGROUND

• Hancock MJ, Maher CG, Latimer J, McAuley JH. Selecting an appropriate placebo for a trial of spinal manipulative therapy. Aust J Physiother. 2006;52(2):135-8. doi: 10.1016/s0004-9514(06)70049-6.

  PMID: 16764551 BACKGROUND

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Imran Amjad, PhD

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Successful blinding of patients or practitioners in a trial involving a physical intervention such as chiropractic care is virtually impossible.18 This is due to the manual nature of the interventions and the challenges associated with providing appropriate sham procedures.18, 19 However, participants in this trial are highly likely to be naïve to chiropractic care so it is possible they will remain unaware of whether they are in the chiropractic or control group. Some study personnel will be aware of the allocated arm as they will be responsible for logistical aspects of the trial. However, the research specialist collecting and analyzing data during the trial will be blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2019
• First Posted: February 21, 2019
• Study Start: February 2, 2019
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: August 1, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)