| CTRI Number |
CTRI/2026/02/104764 [Registered on: 25/02/2026] Trial Registered Prospectively |
| Last Modified On: |
19/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of hippotherapy and NDT on gross motor function and balance in spastic CP children |
|
Scientific Title of Study
|
To Compare the Effects of Hippotherapy Stimulation and Neurodevelopmental Therapy on Gross Motor Function and Balance in children with Spastic Cerebral Palsy |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
monika yadav |
| Designation |
MPT student |
| Affiliation |
gurugram university |
| Address |
department of physiotherapy
Sector 87
Kankrola village
Gurugram
department of physiotherapy
Sector 87
Kankrola village
Gurugram
Gurgaon
HARYANA
122505
India |
| Phone |
09518409424 |
| Fax |
|
| Email |
dr.monikayadavphysio@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shefali Walia |
| Designation |
Associate Professor |
| Affiliation |
gurugram university |
| Address |
department of physiotherapy
Gurugram university
Sector 87
Kankrola village
Gurugram
department of physiotherapy
Gurugram university
Sector 87
Kankrola village
Gurugram
Gurgaon
HARYANA
122505
India |
| Phone |
9891770151 |
| Fax |
|
| Email |
shefaliwalia@gurugramuniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shefali Walia |
| Designation |
Associate Professor |
| Affiliation |
gurugram university |
| Address |
department of physiotherapy
Gurugram university
Sector 87
Kankrola village
Gurugram
department of physiotherapy
Gurugram university
Sector 87
Kankrola village
Gurugram
HARYANA
122505
India |
| Phone |
9891770151 |
| Fax |
|
| Email |
shefaliwalia@gurugramuniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| Gurugram University
department of physiotherapy
Sector 87
Kankrola village
Gurugram |
|
|
Primary Sponsor
|
| Name |
Gurugram University |
| Address |
department of physiotherapy
Sector- 87
Kankrola village
pin code 122505
Gurugram |
| Type of Sponsor |
Research institution |
|
|
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 Monika |
Sunshine Speech and Occupational therapy centre |
54 block N
mayfield garden
sector 51
Gurugram
Gurgaon
HARYANA |
09518409424
dr.monikayadavphysio@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F82||Specific developmental disorder ofmotor function, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Hippotherapy Stimulation and conventional therapy |
Initiate the session with a warm up period of 5 minutes with the progression of treatment as follows: -
•Child sitting forward, with a steady, relaxed walk on straight lines program of hippotherapy stimulator at walking speeds of 90-110 steps/min.
• Treatment for next 15-20 min is Progression of Horse Movement programs:
A. Week 1 and 2:- Figures-circles, serpentines
B. Week 3 and 4:- Abrupt stops and starts sitting forward, backward and side sitting. Progress from eyes open to eyes closed.
D. Week 5 and 6:- Acceleration/deceleration of speed, sitting forward progress to backward sitting and to side sitting.
Followed by active exercises for 10-15 minutes that incudes with the following progression of exercises: -
Level 1(week 1 and 2) – Promote postural alignment: Backward sit, side sitting with support (backward sit increases stretch on adductors, provides conflicting visual flow. Side-sitting increases medial-lateral perturbations and provides conflicting visual flow).
Level 2 (week 3 and 4)- Increase challenge to sitting postural control with anticipatory movements. Arm abduction and elevation in forward sitting with progression to same exercises in backward and then side-sitting.
Level 3(week 5 and 6) - Lower extremity strengthening, core strengthening, and motor planning. (Activities C-D only performed with younger and smaller children(5- 10 years). Older children (10- 15 years) performed activities A and B only)
A. Sit-stand-sit
B. Two-point
C. Child in quadruped position, with cervical extension Progression to raising one hand or leg.
D. Tall kneeling
E. Standing on mechanical hippotherapy stimulator
Followed by 15 minutes of conventional therapy.
Followed by a cool down period of 5 minutes
|
| Intervention |
Neurodevelopmental therapy and conventional therapy |
In IG1: - NDT programs were planned specially for each patient according to their needs. Besides the NDT programs generally contain:
Week 1 and 2
• Vestibular and proprioceptive training on balance board.
• Vestibular and proprioceptive training on exercise balls in different sizes.
• Dynamic balance training in sitting, kneeling and standing position (eyes open and closed).
Week 3 and 4
• Balance exercises in front of the mirror.
• Standing on one foot for improving the proprioceptive input (eyes open and closed).
• Balance training on the trampoline.
• Sensory stimulation for foot soles with various materials.
Week 5 and 6
• Weight bearing exercises in sitting, crawling, kneeling and standing position.
• Functional reaching and ball throwing-keeping exercises in various positions.
• multi-task trainings.
• Walking trainings in different types– Climbing up & stepping down the stairs (supported-unsupported, symmetric, reciprocal etc.). |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
type of cerebral palsy is spastic cerebral palsy
severity of cerebral palsy is level 1 to level 3 according to gross motor function classification system
MMC score must be above 25 |
|
| ExclusionCriteria |
| Details |
Chemo denervation therapy within previous 6 months including administration of botulinum toxin A injection
any muscle lengthening surgery in last one year
Uncontrolled seizures from last one year
moderate to severe intellectual disability
uncorrected visual or hearing acuity
presence of other dysfunctions as learning disability or suffering from other diseases or comorbidities |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Gross Motor Function |
Gross Motor Function |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Balance |
|
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
08/03/2026 |
| 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="0"
Months="4"
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
|
Cerebral palsy (CP) is a group of permanent movement and posture development disorders that typically emerges during childhood and impacts muscle control and motor skills. Among the various CP subtypes, spastic CP is the most prevalent, accounting for over 70% of all CP cases, distinguished by muscle stiffness, motor difficulties, and impaired limb coordination. We are conducting this study to compare the effects of hippotherapy stimulation and neuro developmental therapy on gross motor function and balance in spastic cerebral palsy Patients. The study is conducted in clinical setup of sunshine speech and occupational therapy centre. It includes 50 children divided into two groups of children ranging between 5-15years of age. One group will undergo NDT and conventional therapy and other will undergo hippotherapy stimulation with conventional therapy. |