| CTRI Number |
CTRI/2025/10/096566 [Registered on: 29/10/2025] Trial Registered Prospectively |
| Last Modified On: |
27/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
How doing two activities at the same time can improve hand use, Balance and thinking skills in children with Down syndrome. |
|
Scientific Title of Study
|
The Effect of Dual Task Training on Improving Hand Function, Balance, and Cognitive Flexibility in Children with Down Syndrome. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Durga Chandra |
| Designation |
Post graduate student |
| Affiliation |
Amar Jyoti Institute of physiotherapy Karkardooma,vikas Marg,Delhi 110092 |
| Address |
Amar Jyoti Institute of physiotherapy, Neurology Research Laboratory, Third Floor, Karkardooma, vikas Marg, Delhi 110092
East
DELHI
110092
India |
| Phone |
9340748651 |
| Fax |
|
| Email |
durgachandra208@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Preksha Sharma PT |
| Designation |
Assistant Professor |
| Affiliation |
Amar Jyoti Institute of physiotherapy Karkardooma,vikas Marg,Delhi 110092 |
| Address |
Amar Jyoti Institute of physiotherapy, Neurology Research Laboratory, Third Floor, Karkardooma, vikas Marg, Delhi 110092
East
DELHI
110092
India |
| Phone |
9990640376 |
| Fax |
|
| Email |
prekshas059@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Preksha Sharma PT |
| Designation |
Assistant Professor |
| Affiliation |
Amar Jyoti Institute of physiotherapy Karkardooma,vikas Marg,Delhi 110092 |
| Address |
Amar Jyoti Institute of physiotherapy, Neurology Research Laboratory, Third Floor, Karkardooma, vikas Marg, Delhi 110092
East
DELHI
110092
India |
| Phone |
9990640376 |
| Fax |
|
| Email |
prekshas059@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Durga chandra |
| Address |
Amar Jyoti Institute of physiotherapy Karkardooma,vikas Marg,Delhi 110092 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Durga chandra |
Amar Jyoti Institute of physiotherapy OPD |
Amar Jyoti Institute of physiotherapy
Karkardooma,vikas Marg,Delhi 110092
East
DELHI |
9340748651
durgachandra208@gmail.com |
| Durga chandra |
Parvarish special school |
D-210, Ground Floor, Jhilmil Colony, Behind ESI Hospital, New Delhi-110095
East
DELHI |
9340748651
durgachandra208@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Amar Jyoti Institutional Review Board - Ethical Committee (AJIRB-EC) |
Approved |
| Parvarish Special School |
No Objection Certificate |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q909||Down syndrome, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
A comprehensive dual task training protocol |
1. Standing on a hard surface: The activity involves standing on a hard surface while aiming and throwing a ball
into a basket, and simultaneously saying the names of fruits, colors, vegetables, and animals.
2. Standing on a soft surface: The activity involves standing on a soft surface while aiming and throwing a ball
into a basket, and simultaneously saying the names of fruits, colors, vegetables, and animals.
3. Walking forward, backward and sideways: The activity involves walking forward, backward, and sideways
over a distance of 2 meters while carrying a tray containing cups filled with water and simultaneously saying
the names of fruits, colors, vegetables, and animals.
4. Sit to stand using a stool: The activity involves performing sit-to-stand movements using a stool that allows 90
degrees of hip and knee flexion, with arms crossed over the chest, while simultaneously saying the names of
fruits, colors, vegetables, and animals.
5. Zig-Zag Hopping Task: The activity involves hopping in a zig-zag manner while carrying a ball, focusing on
coordination, balance, and motor control.
6. Ball Dribbling Task: The activity involves dribbling a ball while standing using alternate hands.
7. Fastening Buttons Task: The activity involves fastening buttons of different colors and sizes (small, medium,
and large) while sitting and simultaneously naming the colors of the buttons.
8. Pulling threads from putty: The activity involves pulling and stretching a putty using a sequential pincer grasp.
9. Beading and tying a knot: The activity involves beading and tying a knot after each bead, with a total of five
beads per repetition, while simultaneously naming the colors of the beads.
10. Picking up beads into bottle: The activity involves picking up each bead and placing it into a bottle, while simultaneously naming the colors of the beads.
Intervention (Dual-task training) will be given for 6 weeks, 3 session per week, each session for 45 minutes. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
1. Children diagnosed with Down syndrome.
2. Age between 8 to 16 years, of both genders (male and female).
3. Able to follow simple instructions (e.g., sit-to-stand, pick and throw).
4. Able to ambulate independently for a distance of 10 meters without assistance.
5. Able to verbally name each of the following categories: fruits, vegetables, colors and animals.
6. Intellectual Quotient (IQ) greater than 40
7. Willing to participate in the study with parental consent. |
|
| ExclusionCriteria |
| Details |
1. Having severe comorbidities such as severe cardiovascular disorders (endocardial cushion defects) and musculoskeletal disorders affecting gait.
2. visual or auditory problems.
3. Body mass index (BMI) of greater than or equal to 30 kg/m2. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. NINE HOLE PEG TEST (NHPT)
2. STROOP COLOR AND WORD TEST (SCWT)
3. PAEDIATRIC BALANCE SCALE (PBS) |
2 time points,
At baseline and post intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
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)
|
11/11/2025 |
| 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="0"
Months="6"
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
|
The primary purpose of this study is to evaluate the effect
of dual-task training on improving hand function, balance, and cognitive
flexibility in children with Down syndrome aged 8 to 16 years. Children with
Down syndrome often face challenges in motor skills and cognitive flexibility,
which affect their daily activities, learning, and social participation. Since
motor and cognitive functions are closely interlinked, dual-task training may
help to achieve greater improvements compared to training motor or cognitive
functions alone. By incorporating tasks that simultaneously challenge motor
control and cognitive function (such as naming or categorization), the study
aims to explore whether such an integrated therapeutic approach can promote
functional independence, enhance participation in academic and social
environments, and ultimately improve quality of life in these children. Null Hypothesis - There will be no significant effect of
dual-task training on improving hand function, balance, and cognitive flexibility in children with Down
syndrome aged 8 to 16 years. Alternative Hypothesis - There will be significant
effect of dual-task training on improving hand function, balance, and cognitive flexibility in children with Down
syndrome aged 8 to 16 years.
|