| CTRI Number |
CTRI/2024/04/066417 [Registered on: 26/04/2024] Trial Registered Prospectively |
| Last Modified On: |
26/04/2024 |
| 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
|
Effectivenesss of backward treadmill walking on dynamic balance and gait in children with spastic cerebral palsy |
|
Scientific Title of Study
|
Effect of Backward Treadmill Walking with Different Grades of Inclination on Dynamic Balance and Gait in Children with Spastic Cerebral Palsy : An Experimental 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 |
Mukta Rakhe |
| Designation |
PG student |
| Affiliation |
MAEERs College of physiotherapy Talegaon dabhade. |
| Address |
MAEERS college of physiotherapy neurophysiotherapy department OPD NO A 230
Pune
MAHARASHTRA
410507
India |
| Phone |
9518992001 |
| Fax |
|
| Email |
rakhemukta111@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sayli Paldhikar |
| Designation |
Professor |
| Affiliation |
MAEERS College of Physiotherapy Talegaon Dabhade |
| Address |
MAEERS college of physiotherapy OPD Building 2 floor cabin no 218 near Talegaon railway station Talegaon Dabhade Pune
Pune
MAHARASHTRA
410507
India |
| Phone |
8805174616 |
| Fax |
|
| Email |
saylithuse@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sayli Paldhikar |
| Designation |
Professor |
| Affiliation |
MAEERS College of Physiotherapy Talegaon Dabhade |
| Address |
MAEERS college of physiotherapy OPD Building 2 floor cabin no 218 near Talegaon railway station . Talegaon Dabhade Pune
Pune
MAHARASHTRA
410507
India |
| Phone |
8805174616 |
| Fax |
|
| Email |
saylithuse@gmail.com |
|
|
Source of Monetary or Material Support
|
| MAEERS COLLEGE OF PHYSIOTHERAPY TALEGAON DABHADE PUNE 410507 |
|
|
Primary Sponsor
|
| Name |
MAEERS College of Physiotherapy Talegaon Dabhade |
| Address |
Maeers college of physiotherapy OPD. Building 2 nd floor near talegaon railway station Talegaon Dabhade Pune |
| 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 Sayli Paldhikar |
MAEERs College of Physiotherapy Talegaon Dabhade Pune |
MAEERS college of physiotherapy OPD Building 2nd floor Neurodepartment A230 room no Talegaon Dabhade Pune
Pune
MAHARASHTRA |
8805174616
saylithuse@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAEERS College of Physiotherapy Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Childrens with Spastic Cerebral Palsy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Backward Treadmill Walking |
Backward Treadmills Walking with 5 degree inclination on gait and dynamic balance
protocol will be given 2 times a week for 4 weeks |
| Comparator Agent |
Backward Treadmill Walking |
Backward Treadmill Walking with 10 degree inclination on gait and dynamic balance.protocol will be given 2 times a week for 4 weeks
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1) Spastic cerebral palsy children in the age group 6 to 18
2)classified at 1 or 2 level for gross mototr fuction classification systems
3)Spastic cerebral palsy children who are able to follow verbal command |
|
| ExclusionCriteria |
| Details |
1)childrens with epileptic seizures in last 6 months
2)Fixed deformities in their lower extrimities |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Peadiatric Balance Scale for dynamic balance |
0 week and 6 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 10 meter walk test for speed |
0 week and 6 week |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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 1 |
|
Date of First Enrollment (India)
|
25/05/2024 |
| 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)
|
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
|
focus on improving physical capabilities, independence in daily activities, and overall quality of life for individuals with CP. Physical therapy, occupational therapy, and assistive devices are commonly utilized in the rehabilitation process to help individuals with CP gain strength, improve mobility, and develop skills needed for independent living. Additionally, addressing psychosocial needs and providing support services can help individuals with CP cope with the challenges they face and enhance their overall well-being. Through a multidisciplinary approach, individuals with CP can achieve greater functionality and improved quality of life. |