| CTRI Number |
CTRI/2024/12/078074 [Registered on: 13/12/2024] Trial Registered Prospectively |
| Last Modified On: |
12/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of PNF on gait parameters and balance in down syndrome children. |
|
Scientific Title of Study
|
Effect of rhythmic stabilization on gait parameters and Dynamic balance 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 |
NUSRAT JAHAN |
| Designation |
PhD SCHOLAR |
| Affiliation |
MANAV RACHNA INTERNATIONAL INSTITUTE OF RESEARCH AND STUDIES |
| Address |
Manav Rachna International Institute of research Science,
Department of allied health science (physiotherapy)
first floor
room no 1
Dr Nitesh Malhotra
Physiotherapy department
room no 2
MRIIRS
FARIDABAD HARYANA
Faridabad
HARYANA
121004
India |
| Phone |
8826381195 |
| Fax |
|
| Email |
nusratjahanphysio@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nitesh Malhotra |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
MANAV RACHNA INTERNATIONAL INSTITUTE OF RESEARCH AND STUDIES |
| Address |
Manav Rachna International Institute of research Science,
Department of allied health science (physiotherapy)
first floor
Physiotherapy department
room no 1
MRIIRS
FARIDABAD HARYANA
Faridabad
HARYANA
121004
India |
| Phone |
7503229661 |
| Fax |
|
| Email |
nitesh.sahs@mriu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
NUSRAT JAHAN |
| Designation |
PhD SCHOLAR |
| Affiliation |
MANAV RACHNA INTERNATIONAL INSTITUTE OF RESEARCH AND STUDIES |
| Address |
Manav Rachna International Institute of Research Science, Department of allied health science (Physiotherapy deptt).
Room no 1
First floor (Dr Nitesh Malhotra)
Faridabad
HARYANA
121004
India |
| Phone |
8826381195 |
| Fax |
|
| Email |
nusratjahanphysio@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
MRIIRS |
| Address |
Manav Rachna International Institute of Research Science, Department of allied health science (Physiotherapy)
HARYANA, FARIDABAD,
INDIA
121004 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| nil |
NA |
| NIL |
NIL |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sanjeeda Noor |
ALIGARH MUSLIM UNIVERSITY |
DEIC COE Room no 4 - physiotherapy
Jawaharlal nehru medical college and hospital (JNMCH AMU)
Aligarh
UTTAR PRADESH |
08826381195
nusratjahanphysio@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RESEARCH ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q900||Trisomy 21, nonmosaicism (meioticnondisjunction), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
home based conventional physiotherapy |
weight cuff exercises to leg and pelvis given 3 days in a week for 40 minutes session. The session will consist of 10 repetitions for each exercise, with 6 seconds of contraction hold; between the exercises, 10 seconds of relaxation will be given. 30 seconds of relaxation will be given between the pelvis and lower limb exercise. |
| Intervention |
Rhythmic stabilization, A type PNF proprioceptive neuromuscular facilitations technique applied on Down syndrome children on trunk pelvis and lower limb. |
"40 minutes per session (3 sessions per week for 8 weeks, a total of 24 sessions)" |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects i.e. children with diagnosed cases of Down syndrome, both male and female will be taken.
2. Children between 4-10 years of age,
3. Ability to walk 10 meters with or without an assistive device and/or ankle foot orthosis (AFO),
4. Consent from parents for the study and video recording,
5. Ability to follow the researchers’ and guardians’ instructions.
|
|
| ExclusionCriteria |
| Details |
1. Severe and profound Intellectual disability in Down syndrome children i.e. IQ less than 36. (Right of the Person with Disability act.,
2. Severe and profound Vision or hearing impairment,
3. A major history of disease or surgery or Recent history of any trauma which can hinder mobility and walking,
4. Any musculoskeletal condition hinders mobility and walking (eg: fracture, soft tissue injury),
5. Significant medical or surgical co-morbidities which hinder walking,
6. Uncontrolled seizures disorder and Uncooperative patients
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Cadence,
2. Velocity,
3. Stride length,
4. Step length,
5. Step width
Kinematic parameters: Joint angles in the sagittal plane in degree
1. Hip flexion and extension angles
2. Knee flexion and extension angles
3. Ankle dorsiflexion and planterflexion angles
Balance –
1. Time up and go test
2. Time up and down stairs test
3. Pediatric balance scale
|
baseline and
after 8 week (post intervention)
|
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
23/12/2024 |
| 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)
|
Open to Recruitment |
| 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 study aims to find out the effect of rhythmic stabilization on gait parameters and dynamic balance in children with Down syndrome.
Children with Down syndrome have altered gait patterns and balance control after even achieving it at a later age due to motor delay. This could be because of poor tone and ligament laxity resulting in delayed milestones. Possibly children can have better dynamic balance control and improved gait pattern after the intervention with rhythmic stabilization (proprioceptive neuromuscular function). It is assumed for improving the spatiotemporal and kinematic gait parameters with an increase in stride length, step length, velocity, and cadence and a decrease in step width. Also, the dynamic balance may improve with an increase in balance scores after intervention.
|