Chiropractic Care on Behavior, Neurological Function and Quality of Life in ADHD Children - A Pilot Study
Primary Purpose
Attention Deficit Disorder With Hyperactivity
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Experimental group
Control group
Sponsored by
About this trial
This is an interventional treatment trial for Attention Deficit Disorder With Hyperactivity focused on measuring Attention Deficit Disorder with Hyperactivity, Children, Chiropractic, Neurological function, Quality of life
Eligibility 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
Sites / Locations
- Riphah International University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental group
Control group
Arm Description
Chiropractic care
Usual health care
Outcomes
Primary Outcome Measures
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.
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.
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
Secondary Outcome Measures
Full Information
NCT ID
NCT03849807
First Posted
February 20, 2019
Last Updated
July 27, 2022
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT03849807
Brief Title
Chiropractic Care on Behavior, Neurological Function and Quality of Life in ADHD Children - A Pilot Study
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
February 2, 2019 (Actual)
Primary Completion Date
June 1, 2019 (Actual)
Study Completion Date
June 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Disorder With Hyperactivity
Keywords
Attention Deficit Disorder with Hyperactivity, Children, Chiropractic, Neurological function, Quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes 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.
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Chiropractic care
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Usual health care
Intervention Type
Other
Intervention Name(s)
Experimental group
Intervention Description
the intervention group will receive 4 weeks of chiropractic care along with usual care(Cognitive-Behavioral, psychosocial Therapy).
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
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 Measure Information:
Title
Vanderbilt Attention Deficit Hyperactivity Disorder (ADHD) Diagnostic Rating Scale
Description
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.
Time Frame
baseline,4th week, 8th week
Title
Swanson, Nolan and Pelham (SNAP) Questionnaire
Description
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.
Time Frame
baseline,4th week, 8th week
Title
ADHA Attention Deficit Hyperactivity Disorder Rating Scale IV (Home version)
Description
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
Time Frame
baseline,4th week, 8th week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Imran Amjad, PhD
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riphah International University
City
Islamabad
State/Province
Federal
ZIP/Postal Code
44000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
15665153
Citation
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Chiropractic Care on Behavior, Neurological Function and Quality of Life in ADHD Children - A Pilot Study
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