| CTRI Number |
CTRI/2025/12/098465 [Registered on: 04/12/2025] Trial Registered Prospectively |
| Last Modified On: |
03/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
ow Exercise and cognitive Training Help Teens with Diabetes: A 12-Month Study |
|
Scientific Title of Study
|
Long-Term Effect of Motor-Cognitive Intervention on Functioning based on ICF Framework in Adolescents with Juvenile Diabetes: A 12-Month Experimental Follow-up Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chayarani Bora |
| Designation |
Assistant Professor, PhD Scholar |
| Affiliation |
Assistant Professor, Department of Neurophysiotherapy,MGM School of Physiothreapy, Chh. Sambhajinagar,a Constituent Unit of MGM Institute of Health Sciences, Navi Mumbai |
| Address |
Department of Neurophysiotherapy, MGM School of Physiotherapy, C-Building, Gate No-3, MGM Medical College and Hospital, N-5, Cidco, chh. Sambhajinagar
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
09577009060 |
| Fax |
|
| Email |
chayaranibora9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Chayarani Bora |
| Designation |
Assistant Professor |
| Affiliation |
Assistant Professor, Department of Neurophysiotherapy, MGM School of Physiotherapy, Chh. Sambhajinagar- A Constituent Unit of MGM Institute of Health Sciences, Navi Mumbai |
| Address |
Department of Neurophysiotherapy,Gate No-3, C-Building, MGM Medical College and Hospital, Cidco, N-6, Chh. Sambhajinagar
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
09577009060 |
| Fax |
|
| Email |
chayaranibora9@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Triveni Shetty |
| Designation |
Associate Professor |
| Affiliation |
Associate Professor, Department of Neurophysiotherapy, MGM School of Physiotherapy, Sector -1, Kamothe, Navi Mumbai, Constituent Unit of MGM Institute of Health Sciences, Navi Mumbai |
| Address |
Department of Neurophysiotherapy, MGM School of Physiotherapy
Sector -1,Kamothe,Navi Mumbai-410209
Maharashtra, India
Mumbai
MAHARASHTRA
410209
India |
| Phone |
9920633288 |
| Fax |
|
| Email |
tshetty@mgmsopnm.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Chayarani Bora |
| Address |
Assistant Professor, PhD Scholar, Department of Neurophysiotherapy, MGM School of Physiotherapy, Gate No-3, C-Building, MGM Medical College and Hospital, N-5, Cidco-431003, Sambhajinagar- A Constituent Unit of MGM Institute of Health Sciences, Navi Mumbai
|
| Type of Sponsor |
Other [Self Sponsored ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Chayarani Bora PT |
Department of Physiotherapy, MGM Medical College & Hospital, Chh. Sambhajinagar |
Department of Neurophysiotherapy, MGM School of Physiotherapy,Gate No-3, C-Building, MGM Medical College and Hospital, N-6, Cidco-431003, Chh. Sambhajinagar- A Constituent Unit of MGM Institute of Health Sciences, Navi Mumbai
Aurangabad
MAHARASHTRA |
09577009060
chayaranibora9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Comittee for Research on Human Subject,MGM Institute of Health Sciences, Navi Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E109||Type 1 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Intervention |
ConventionalIntervention
Intervention Period 12 weeks
Frequency 3 to 5 days per week according to the type of the exercise
Type of Exercises
Exercises Types Aerobic Exercises
Muscle strengthening Exercises
Daily Activities specific to Aerobic activities Muscle-strengthening activities Bonestrengthening activities
Intensity Moderate- to vigorous to intensity aerobic activity daily
Time 60 minutes per session |
| Intervention |
Experimental Intervention
Motor Cognitive Intervention |
Intervention Period 12 weeks
Level I 1 to3 weeks
Level II 4to 6 weeks
Level III 7 to 9 weeks
Level IV 10 to 12 weeks
Type of Exercises
Targeting Motor Performance Flexibility Exercise, Strengthening Exercise Endurance exercise
Targeting Cognitive Performance Memory Cognition Attention Reasoning
Group Activities Play Craft activities
Intensity Starting with low intensity to moderate intensity exercises
Frequency 3 to 5 days per week according to the type of the exercise
Time 60 minutes with warm up and cool down Period
A follow- up with the children and their parent after completing one level |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Adolescents aged 12–18 years diagnosed with Type1 diabetes mellitus for at least 6 months, Primary Care givers of these adolescents, Willingness to participate and provide informed consent/assent |
|
| ExclusionCriteria |
| Details |
Adolescents or caregivers with diagnosed significant cognitive impairments, Non- consenting adolescents or caregivers |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Physical Function:
•Flexibility: Sit and Reach Test
•
Strength: Hand Grip Strength
•
Endurance: Shuttle Run Test
Cognitive Function:
•Wechsler Intelligence Scale for Children (WISC-V)
Fine Motor Skills:
•
Bruininks-Oseretsky Test of Motor Proficiency (BOT-2)
Balance:
•Pediatric Berg Balance Scale
Social and Physical Participation:
•Pediatirc Quality of Life Inventory (PedsQL)
•Children’s Assessment of Participation and Enjoyment (CAPE)
|
Baseline, 3 months, 6 months,12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Personal Factors
•Glycemic Level
•Weight
•Height
•BMI
•Adolescent Sleep Hygiene Scale (ASHS)
Environmental Factors
Environmental Factors Checklist (ICF-based) |
Baseline, 3 months, 6 months, 9 months and 12 months |
|
|
Target Sample Size
|
Total Sample Size="116"
Sample Size from India="116"
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)
|
11/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Study setting is 1. MGM School of Physiotherapy, Chh Sambhajinagar. 2. Udaan Empowering Children with Type 1 Diabetes, NGO, Chh Sambhajinagar |