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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03849807
Recruitment Status : Completed
First Posted : February 21, 2019
Last Update Posted : July 1, 2019
Sponsor:
Information provided by (Responsible Party):
Imran Amjad, Riphah International University

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.

Condition or disease Intervention/treatment Phase
Attention Deficit Disorder With Hyperactivity Other: Experimental group Other: Control group Not Applicable

Detailed Description:

ADHD is a disorder that may affect an individual's academic performance, social interactions, and interpersonal relationships amongst others. It is characterized by impulsiveness, hyperactivity, and inattention. It was previously thought that children overcome ADHD as they grow up, however, recent studies suggest that 30-60% of affected individuals continue to show significant symptoms of the disorder as adults and have associated difficulties such as lower educational and employment achievement. Conventional therapeutic approaches that are used with individuals with ADHD generally involve pharmaceutical interventions and behavioral therapies such as counseling and behavioral modification. However, little is known about the long term effectiveness of these treatment approaches which are also known to involve significant risks and complications.

ADHD is a neurodevelopmental disorder that is associated with significant alterations in brain development and function. These include changes in fronto-striatal pathways that can lead to difficulties with "top-down" control. It is also likely that connections in the parietal lobe and cerebellum are involved. These neurological changes are associated with a number of alterations to sensory filtering, sensorimotor gating, and sensorimotor control. This lends itself to a potential role for chiropractors in caring for children with ADHD because chiropractic care has been shown to alter a number of aspects of sensorimotor function.

Chiropractic is based on the theory that spinal adjustments applied to areas of spinal dysfunction, known as vertebral subluxations, can improve the function of the nervous system. Our research group has been testing this theory for the last 15 years. We have hypothesized that the articular dysfunction component of the vertebral subluxation results in altered afferent input to the central nervous system (CNS) that modifies the way in which the CNS processes and integrates all subsequent sensory input. This processing (i.e. sensorimotor integration), is a CNS function that appears most vulnerable to altered inputs. Recent studies have shown that chiropractic care alters sensorimotor filtering, cortical and cerebellar motor processing, and multisensory processing, all of which may be important in the neurodevelopment of ADHD. Given the nature of the neurological changes associated with ADHD and the growing body of evidence that suggests that chiropractic care may influence neurological function, it is possible that chiropractors may play a role in enhancing the neurological function of individuals with ADHD.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: The Effects of Chiropractic Care on Behavior, Neurological Function and Quality of Life in Children With Attention Deficit Hyperactivity Disorder: A Randomized Controlled Pilot Study
Actual Study Start Date : February 2, 2019
Actual Primary Completion Date : June 1, 2019
Actual Study Completion Date : June 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental group
Chiropractic care
Other: Experimental group
the intervention group will receive 4 weeks of chiropractic care along with usual care(Cognitive-Behavioral, psychosocial Therapy).

Active Comparator: Control group
Usual health care
Other: Control group
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.




Primary Outcome Measures :
  1. Vanderbilt Attention Deficit Hyperactivity Disorder (ADHD) Diagnostic Rating Scale [ Time Frame: baseline,4th week, 8th week ]

    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.


  2. Swanson, Nolan and Pelham (SNAP) Questionnaire [ Time Frame: baseline,4th week, 8th week ]
    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.

  3. ADHA Attention Deficit Hyperactivity Disorder Rating Scale IV (Home version) [ Time Frame: baseline,4th week, 8th week ]

    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




Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03849807


Locations
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Pakistan
Riphah International University
Islamabad, Federal, Pakistan, 44000
Sponsors and Collaborators
Riphah International University
Investigators
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Principal Investigator: Imran Amjad, PhD Riphah International University
Publications:

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Responsible Party: Imran Amjad, Associate Professor, Riphah International University
ClinicalTrials.gov Identifier: NCT03849807    
Other Study ID Numbers: RiphahIU Imran khan Niazi2
First Posted: February 21, 2019    Key Record Dates
Last Update Posted: July 1, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Imran Amjad, Riphah International University:
Attention Deficit Disorder with Hyperactivity
Children
Chiropractic
Neurological function
Quality of life
Additional relevant MeSH terms:
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Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases