Fidget Ball for ADHD
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of California, Davis
Must be taking: Stimulants
Must not be taking: Psychoactive medications
Disqualifiers: Depression, Psychotic disorders, Autism, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This project will study how fidgeting relates to cognitive and emotional functioning in adults with attention-deficit/hyperactivity disorder (ADHD). It will determine, in a laboratory setting, whether movement and access to a "fidget device" providing sensory and motor stimulation can improve cognitive and emotional regulation (including on physiological measures) in adult ADHD. The investigators will also acquire pilot data for machine learning analyses to be used in future, large scale studies to identify gestures and touch characteristics associated with improved cognitive and emotional regulation to see if the data can predict and subsequently develop recommendations to improve performance and emotional control in natural settings (e.g., home, office, college classroom) for adult ADHD.
Will I have to stop taking my current medications?
The trial requires that you stop taking any psychoactive medications, except for stimulant medications for ADHD or medications that can affect heart rate.
What data supports the effectiveness of the treatment Fidget Ball for ADHD?
Research on similar fidget toys, like fidget spinners, shows mixed results. One study found that fidget spinners helped some students with ADHD stay on task in class, while another study found they could actually worsen attention in young children with ADHD.
12345Is the fidget ball safe for use in humans?
There have been reports of fidget spinners, a similar type of fidget toy, being ingested by children, which sometimes required medical intervention. This suggests a potential safety risk if not used properly, especially with young children.
12456How does the Fidget Ball treatment for ADHD differ from other treatments?
The Fidget Ball treatment for ADHD is unique because it involves using a physical object to help improve focus and attention, similar to fidget spinners, which have been shown to increase on-task behavior in children with ADHD. Unlike traditional medications, this treatment provides a non-drug alternative that engages motor skills and activates brain areas associated with planning and reward.
12578Eligibility Criteria
This trial is for adults with ADHD who often fidget. Participants should not have severe depression, psychotic disorders, autism, significant visual or hearing impairments, an IQ below 85, or be on psychoactive meds (except for ADHD stimulants).Inclusion Criteria
You have been diagnosed with ADHD (Attention-Deficit/Hyperactivity Disorder).
You have a history of being unable to sit still or constantly moving around.
Exclusion Criteria
I am on medication for mental health, but not for ADHD or anything that affects heart rate.
I do not have any mental health issues or sensory impairments that would affect my participation.
Your IQ (intelligence quotient) score is lower than 85.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Treatment
Participants are assessed for cognitive and emotional regulation with and without a fidget device in a laboratory setting
1 day
1 visit (in-person)
Follow-up
Participants are monitored for any changes in cognitive and emotional regulation post-assessment
2 weeks
Participant Groups
The study examines if a 'fidget ball' can help adults with ADHD better manage their attention and emotions. It will collect data in a lab setting to see if this device improves cognitive and emotional control.
2Treatment groups
Experimental Treatment
Active Control
Group I: With fidgetExperimental Treatment1 Intervention
The participant is given a specially designed fidget ball
Group II: No fidgetActive Control1 Intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
UC Davis MIND InstituteSacramento, CA
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Who Is Running the Clinical Trial?
University of California, DavisLead Sponsor
References
Using Fidget Spinners to Improve On-Task Classroom Behavior for Students With ADHD. [2022]Using fidget toys is one way to allow students with attention-deficit/hyperactivity disorder (ADHD) to move while completing academic assignments in the classroom. This study investigated the effect of fidget spinners on the on-task behavior of three second-grade students with ADHD. Before beginning treatment, the rules of use were briefly explained and demonstrated to students by the researchers; students were then provided with fidget spinners during treatment sessions in language arts class. A multiple-baseline design across students was used to determine whether each student had higher levels of on-task behavior when using the fidget spinner. Momentary time sampling was used to record on-task behavior; visual analysis of time-series graphs showed large immediate and sustained increases in on-task behavior during fidget spinner use. Implications for implementing a fidget spinner intervention and suggestions for future research are discussed.
Fidget spinners: Purported benefits, adverse effects and accepted alternatives. [2018]In the span of a few months, fidget spinners have caught the eyes of millions of children, parents, educators and paediatricians. Fidget spinners, hand-held toys designed to spin freely in your grasp, have become a source of entertainment for consumers of all ages. Despite a lack of scientific evidence, toy marketers have advertised the benefits of fidget spinners for children with attention-deficit/hyperactivity disorder and other disorders (e.g. autism, anxiety, sensory issues). Parents are incentivized by these purported benefits to purchase fidget spinners to improve their child's concentration and decrease stress.
Classroom seating for children with attention deficit hyperactivity disorder: therapy balls versus chairs. [2019]The purpose of this study was to investigate the effects of therapy balls as seating on in-seat behavior and legible word productivity of students with attention deficit hyperactivity disorder (ADHD). Additionally, social validity was assessed to evaluate teacher and student opinions regarding the intervention.
To Fidget or Not to Fidget, That Is the Question: A Systematic Classroom Evaluation of Fidget Spinners Among Young Children With ADHD. [2022]Objective: To examine how fidget spinners affect children with ADHD's gross motor activity and attentional functioning in class, both during the initial and final phase of an intensive evidence-based behavioral treatment. Method: Using an A-B-A-B design, 60 children (Mage = 4.86 years, 83% Hispanic) diagnosed with ADHD participated in the study. Following a baseline period, four random children from each classroom were given fidget spinners across three separate days (n = 48). Children wore accelerometers and were videotaped for 5-min during class in which attentional data were coded. Results: During the initial phase of treatment (but not during the final phase), the use of fidget spinners was associated with a decrease in activity levels. Children's use of fidget spinners was associated with poorer attention across both phases of treatment. Conclusion: Fidget spinners negatively influence young children with ADHD's attentional functioning, even in the context of an evidence-based classroom intervention.
Radiographic appearance and clinical significance of fidget spinner ingestions. [2019]According to anecdotal press reports, there have been medically significant ingestions of fidget spinner toys, including ingestions that required endoscopic intervention. Fidget spinners have been marketed to improve attention and have been suggested as a therapeutic alternative to medications in children with attention deficit hyperactivity disorder (ADHD).
The occurrence of adverse drug reactions reported for attention deficit hyperactivity disorder (ADHD) medications in the pediatric population: a qualitative review of empirical studies. [2021]To review empirical studies of adverse drug reactions (ADRs) reported to be associated with the use of medications generally licensed for treatment of attention deficit hyperactivity disorder (ADHD) symptoms in the pediatric population.
Cortico-striatal activity associated with fidget spinner use: an fMRI study. [2023]Fidget spinners are said to be a very successful toy, and it's said that it has a good impact on attention for children with ADHD and hand motor control. However, there is limited scientific evidence to support these claims, and there is a lack of data on neurobiological responses to rotating fidget spinners. To better understand the mechanism whereby fidget spinners affect motor behavior, we tried to identify the neural correlates of rotating fidget spinners using functional magnetic resonance imaging and non-magnetic fidget spinners with five types of ease of rotation. As a result, we confirmed that the pre/postcentral gyrus, middle temporal gyrus, supplementary motor area (SMA), cerebellum, and striatum are activated when rotating spinners. Furthermore, the SMA was activated more with easier-to-rotate spinners. Additionally, a psychophysiological interaction analysis revealed increased functional connectivity between the SMA and the caudate while rotating fidget spinners compared to just holding them. These results suggest that the fine motor control associate with spinning a fidget spinner is supported by the cortico-striatal circuits involved in planning and reward.
Play preference of children with ADHD and typically developing children in Brazil: a pilot study. [2015]Children with attention deficit hyperactivity disorder (ADHD) have been reported to have play deficits, which can cause problems in occupational development. The aim of this paper was to report research findings on children with ADHD and typically developing children in relation to preference of play partners, play places, toys and type of play.