| CTRI Number |
CTRI/2025/09/094378 [Registered on: 08/09/2025] Trial Registered Prospectively |
| Last Modified On: |
04/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effects of pelvic proprioceptive neuromuscular facilitation technique on balance and gait parameters of children with Down syndrome- pre-post interventional study |
|
Scientific Title of Study
|
The effect of pelvic Proprioceptive Neuromuscular Facilitation technique on balance and gait parameters in children with Down Syndrome- a pre-post interventional 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 |
Nikita Yadav |
| Designation |
Postgraduate student |
| Affiliation |
YMT college of physiotherapy |
| Address |
301, 3rd floor, department of Neuro physiotherapy, YMT college of physiotherapy, Kharghar, sector 4, Navi Mumbai
301, 3rd floor, department of Neuro physiotherapy, YMT college of physiotherapy, Kharghar, sector 4, Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9867143891 |
| Fax |
|
| Email |
ynikita126@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sharda Bhalerao |
| Designation |
Thesis guide |
| Affiliation |
YMT college of physiotherapy |
| Address |
301, 3rd floor, department of Neuro physiotherapy, YMT college of physiotherapy, Kharghar, sector 4, Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9850059332 |
| Fax |
|
| Email |
bhaleraosharda90@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sharda Bhalerao |
| Designation |
Thesis guide |
| Affiliation |
YMT college of physiotherapy |
| Address |
301, 3rd floor, department of Neuro physiotherapy, YMT college of physiotherapy, Kharghar, sector 4, Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9850059332 |
| Fax |
|
| Email |
bhaleraosharda90@gmail.com |
|
|
Source of Monetary or Material Support
|
| YMT college of physiotherapy, kharghar, 410210 |
|
|
Primary Sponsor
|
| Name |
YMT college of physiotherapy |
| Address |
sector 4, kharghar, navi mumbai |
| Type of Sponsor |
Private medical college |
|
|
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 Sharda Bhalerao |
YMT college of physiotherapy |
301, 3rd floor, department of Neuro physiotherapy, YMT college of physiotherapy, Kharghar, sector 4, Navi Mumbai
Raigarh
MAHARASHTRA |
9850059332
ynikita126@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, YMTcollege of physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q90||Down syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Proprioceptive Neuromuscular Facilitation technique |
30 mins of pelvic PNF, 5 days a week for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
clincally diagnosed children with Down syndrome between 5-12 years with pre-determind IQ score between 50-69 and are able to walk independently with or without walking aid |
|
| ExclusionCriteria |
| Details |
fractures of lower limb, recurrent dislocations, visual or auditory impairments, cardio-respiratory complications, other neurological conditions |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pediatric Balance Scale
Gait parameters |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="29"
Sample Size from India="29"
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)
|
15/09/2025 |
| 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="1"
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
|
Hypothesis Null Hypothesis-Pelvic Proprioceptive Neuromuscular Facilitation technique will have no significant effect on balance and gait parameters in children with Down syndrome. Alternate Hypothesis-Pelvic Proprioceptive Neuromuscular Facilitation technique will have a significant effect on balance and gait parameters in children with Down syndrome.
Brief summary This pre–post interventional study investigates the effect of pelvic PNF techniques on balance and gait parameters in children with Down syndrome, a genetic disorder often associated with hypotonia, ligament laxity, delayed motor milestones, and poor postural control. These impairments frequently lead to gait abnormalities such as reduced velocity, shorter step/stride length, and increased step width, which negatively impact independence and quality of life. The pelvis is considered a key point of control for gait. Pelvic PNF has been used successfully in populations such as stroke and cerebral palsy to improve pelvic alignment, trunk control, balance, and gait. However, there is limited research on its effectiveness in children with Down syndrome. In this study, 29 children aged 5–12 years with mild intellectual disability (IQ 50–69) and independent walking ability will undergo a 4-week pelvic PNF training protocol (5 sessions/week, 30 minutes each). Balance will be assessed using the Pediatric Balance Scale (PBS), and gait will be evaluated using spatiotemporal parameters (step length, step width, stride length, cadence, gait velocity) measured through ink footprints and timing methods. The data will be analyzed with paired t-test or Wilcoxon signed-rank test depending on normality. The study aims to provide evidence on whether pelvic PNF can significantly improve gait and balance, thereby enhancing mobility, independence, and quality of life in children with Down syndrome |