| CTRI Number |
CTRI/2025/08/092445 [Registered on: 05/08/2025] Trial Registered Prospectively |
| Last Modified On: |
01/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effect of Sensorimotor Exercises on Executive Function of Children with ADHD |
|
Scientific Title of Study
|
Effect of Upper and Lower Limb-Specific Sensorimotor Exercises on Executive Function of Children with ADHD: A four-arm Randomized Controlled Trial (SEADHD Trial) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kazi Md Azman Hossain |
| Designation |
Intern Physiotherapist |
| Affiliation |
Jashore University of Science and Technology (JUST), Jashore |
| Address |
Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology (JUST), Jashore-7408, Bangladesh
Jashore-7408, Bangladesh
7408
Other |
| Phone |
01660140833 |
| Fax |
|
| Email |
azmanhossain51@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kazi Md Azman Hossain |
| Designation |
Intern Physiotherapist |
| Affiliation |
Jashore University of Science and Technology (JUST), Jashore |
| Address |
Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology (JUST), Jashore-7408, Bangladesh
Jashore-7408, Bangladesh
7408
Other |
| Phone |
01660140833 |
| Fax |
|
| Email |
azmanhossain51@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kazi Md Azman Hossain |
| Designation |
Intern Physiotherapist |
| Affiliation |
Jashore University of Science and Technology (JUST), Jashore |
| Address |
Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology (JUST), Jashore-7408, Bangladesh
Jashore-7408, Bangladesh
7408
Other |
| Phone |
01660140833 |
| Fax |
|
| Email |
azmanhossain51@gmail.com |
|
|
Source of Monetary or Material Support
|
| Physiotherapy and Rehabilitation Department, Jashore University of
Science and Technology (JUST), Jashore-7408, Bangladesh |
|
|
Primary Sponsor
|
| Name |
Kazi Md Azman Hossain |
| Address |
Jashore-7408, Bangladesh |
| Type of Sponsor |
Other [self-funded] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Jashore University of Science and Technology JUST |
Jashore-7408, Bangladesh |
|
|
Countries of Recruitment
|
Bangladesh |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Suraiya Yesmin Sharna |
Dr. M R Khan Medical Centre |
Room No: 304; Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology (JUST), Jashore-7408, Bangladesh
|
01786395080
sharnajust1019@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board (IRB) of the Department of Physiotherapy and Rehabilitation at Jashore University of Science and Technology |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F902||Attention-deficit hyperactivity disorder, combined type, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group: Usual care (UC) |
The control group will receive usual care, including standard clinical management such as behavioral counselling, parental guidance, and educational support as provided by their regular healthcare professionals for this study timeline. No structured sensorimotor exercise will be delivered by the study team. Participants may continue existing treatments, including prescribed medications, as per their physician’s advice. Any changes in medical or behavioral care during the study will be documented. This approach reflects routine care practices and serves as an appropriate comparison to evaluate the effects of the sensorimotor interventions. |
| Intervention |
Experimental Group A: Upper Limb Sensorimotor Exercise (ULSE) |
Participants in Group A will engage in a structured Upper Limb Sensorimotor Exercise (ULSE) program tailored to enhance fine motor skills, coordination, and upper extremity control. The intervention follows a three-phase progression across 24 sessions over eight weeks (three sessions/week). Each session comprises a 5–7-minute warm-up, 25-30 minutes of targeted sensorimotor tasks, and a 5–7-minute cool-down. Phase 1 (Sessions 1–8) introduces foundational upper limb movements through activities such as checkerboard hand tapping, bean bag toss, clothespin transfers, squeeze ball exercises, pegboard placement, and straw threading combined with basic warm-up and cool-down stretches. Phase 2 (Sessions 9–18) advances to more complex tasks involving visual cues and balance components (e.g., cup stack race, resistance band pulls, balloon volleyball, and targeted sponge squeeze relay). Phase 3 (Sessions 19–24) incorporates cognitive demands like timed recall and rhythmic tapping using tools such as wall ball bounce, pencil maze navigation, elastic band finger drills, coin flipping challenge, and domino pattern recreation. Each activity will be performed for 3 sets of 15 repetitions, tailored to the child’s ability level and progression. The ULSE intervention aims to improve sensorimotor integration, attention, and executive function in children with ADHD. |
| Intervention |
Experimental Group B: Lower Limb Sensorimotor Exercise (LLSE) |
Group B participants will receive Lower Limb Sensorimotor Exercise (LLSE) interventions designed to develop balance, gross motor coordination, and proprioceptive awareness. Spanning the same duration and frequency as other groups, each session includes dynamic warm-ups (e.g., heel-toe walks, leg swings), progressive sensorimotor tasks, and specific lower limb stretches. In Phase 1 (Sessions 1–8), children perform foundational lower-body activities such as checkerboard foot stepping, cone zig-zag walks, balloon tapping, mini-squats guided by visual cues, step-over rope ladder, and toe-target tapping. Phase 2 (Sessions 9–18) escalates task complexity with pattern-based skipping, ball control, obstacle navigation, tug-of-war band walks, and hurdle hop sequences. By Phase 3 (Sessions 19–24), participants engage in advanced drills like multi-step checkerboard footwork, jump-freeze sequences, stability-focused balance disc games, clock-hop coordination, and bean bag foot scoop and toss. Each activity will be performed for 3 sets of 15 repetitions, tailored to the child’s ability level and progression. This lower limb–centered program targets improvements in postural stability, cognitive-motor dual-tasking, and self-regulation capacities critical to managing ADHD symptoms. |
| Intervention |
Experimental Group C: Upper and Lower Limb Sensorimotor Exercise (ULLSE) |
Group C will participate in a combined Upper and Lower Limb Sensorimotor Exercise (ULLSE) program, integrating full-body coordination and bilateral limb control. The sessions follow the same structure and schedule, emphasizing global motor planning, rhythm, and cross-limb integration. Phase 1 (Sessions 1–8) introduces whole-body movements, including checkerboard full-body taps, animal walks, marching with clapping, squat-to-shoulder taps, and bean bag pass while balancing. Phase 2 (Sessions 9–18) introduces cross-limb coordination with obstacle-based crawling, hand-foot rhythmic movements, interactive ball drills, balance-step punches, and partner mirror movements. Phase 3 (Sessions 19–24) focuses on executive function and dual-task performance through timed checkerboard patterns, coordination circuits (hop/twist/throw), motor-cognitive relays like jump-throw-catch, memory-pattern obstacle chase, and relay tag with motor task. Each activity will be performed for 3 sets of 15 repetitions, tailored to the child’s ability level and progression. The comprehensive nature of the ULLSE program leverages motor-cognitive function, which is supported by emerging evidence for improving attention, working memory, and behavioral regulation in children with ADHD. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
13.00 Year(s) |
| Gender |
Both |
| Details |
Participants will be included if: (1) children aged between 6 and 13 years; (2) have a clinical diagnosis of Attention Deficit Hyperactivity Disorder (ADHD) confirmed by a qualified developmental pediatrician, clinical psychologist, or psychiatrist; (3) possess an intelligence quotient (IQ) score above 80, as measured by the Wechsler Intelligence Scale for Children (WISC); and (4) have a formal recommendation for participation from a licensed physician or psychologist. |
|
| ExclusionCriteria |
| Details |
Participants will be excluded if: (1) diagnosis of any major neurodevelopmental or psychiatric disorder, such as autism spectrum disorder, intellectual disability, or cerebral palsy; (2) presence of acute or chronic medical conditions that may limit or prevent participation in physical activity; (3) a history or tendency of experiencing seizures or convulsions; (4) documented drug dependence prior to the intervention; or (5) inability to perform the physical activities involved in the intervention or difficulty in following instructions. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Executive Function
Inhibitory Control (IC) - Arrow Flanker Task
Working Memory (WM) - Tower of London
Cognitive Flexibility (CF) - Trail Making Test
Overall: Behavior Rating Inventory of Executive Function (BRIEF) |
At baseline, week-4, week-8 and week-20 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Social behavior and overall ADHD symptoms
Social behavior - Conners’ Teacher Rating Scale 15-Item (CTRS-15)
Overall ADHD symptoms - Strengths and Weaknesses of ADHD Symptoms and Normal Behavior (SWAN) scale
Physical activity
Physical Activity Questionnaire for Children (PAQ-C)
Affective state
Feeling State: One-Item Feeling State Questionnaire (11-point version)
Enjoyment: Physical Activity Enjoyment Scale (PACES)
Program Adherence
Attendance frequency and dropout rate |
At baseline, week-4, week-8 and week-20 |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="0"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
18/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
18/08/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This four-arm randomized
controlled trial, titled the SEADHD Trial, aims to evaluate the effects of
upper limb, lower limb, and combined sensorimotor exercises on executive
function in children aged 6–13 years with ADHD. Participants are randomly
assigned to one of three intervention groups—Upper Limb Sensorimotor Exercise
(ULSE), Lower Limb Sensorimotor Exercise (LLSE), or Upper and Lower Limb
Sensorimotor Exercise (ULLSE)—each delivered over 24 structured sessions across
8 weeks, or to a control group receiving usual care. Each exercise program
progressively enhances motor skills, coordination, and cognitive engagement
through tailored, phase-wise activities. The primary outcomes include measures
of executive function (inhibitory control, working memory, cognitive
flexibility, and behavioral regulation), while secondary outcomes assess social
behavior, ADHD symptoms, physical activity, affective state, and program
adherence. This study seeks to provide evidence on the efficacy of sensorimotor
interventions in improving executive functioning and behavior in children with
ADHD. |