CTRI Number |
CTRI/2023/03/050826 [Registered on: 20/03/2023] Trial Registered Prospectively |
Last Modified On: |
18/03/2023 |
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 between motor dual task training and cognitive dual task training on balance in children with cerebral palsy |
Scientific Title of Study
|
Comparative effectiveness of motor dual task training and cognitive dual task training on balance in children with cerebral palsy |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
devan |
Designation |
physiotherapy |
Affiliation |
indian spinal injury centre |
Address |
indian spinal injury centre vasant kunj delhi
New Delhi DELHI 110070 India |
Phone |
8383936478 |
Fax |
|
Email |
devankashyap98@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
garima wadhwa |
Designation |
physiotherapy |
Affiliation |
Indian spinal injury center |
Address |
physiotherapy department , 2nd floor physiotherapy department , 2nd floor New Delhi DELHI 110070 India |
Phone |
9650086472 |
Fax |
|
Email |
garimawdhw@gmail.com |
|
Details of Contact Person Public Query
|
Name |
garima wadhwa |
Designation |
physiotherapy |
Affiliation |
Indian spinal injury center |
Address |
physiotherapy department , 2nd floor physiotherapy department 2nd floor New Delhi DELHI 110070 India |
Phone |
9650086472 |
Fax |
|
Email |
garimawdhw@gmail.com |
|
Source of Monetary or Material Support
|
INDIAN SPINAL INJURY CENTRE, Sector C , vasant kunj , new delhi |
|
Primary Sponsor
|
Name |
NA |
Address |
NA |
Type of Sponsor |
Other [no sponsors] |
|
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 |
devan |
Indian Spinal Injury Center |
Rehabilitation Departement Sector C , vasant kunj second floor, admin office, room no. 1
New Delhi
DELHI New Delhi DELHI |
8383936478
devankashyap98@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
devan kashyap |
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 |
cognitive task training |
4 weeks |
Intervention |
dual motor task training |
4 weeks |
|
Inclusion Criteria
|
Age From |
6.00 Year(s) |
Age To |
12.00 Year(s) |
Gender |
Both |
Details |
1.Stand independently for at least 30 seconds.
2.Walk independently with or without an assistive device
3.Understand protocol and parents give informed consent.
4.Gross motor functional measure I and II. |
|
ExclusionCriteria |
Details |
1.Children, who are uncooperative
2.Have history of epilepsy
3.With hearing, visual and speech deficit
4.Any cardiac anomalies affecting exercise tolerance. |
|
Method of Generating Random Sequence
|
Stratified randomization |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
gross motor function measure |
4 weeks |
|
Secondary Outcome
|
Outcome |
TimePoints |
functional reach test |
4 weeks |
peadiatric balance scale |
4 weeks |
|
Target Sample Size
|
Total Sample Size="20" Sample Size from India="20"
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)
|
20/03/2023 |
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="2" Days="0" |
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
none yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
The aim of this research is to find the effectiveness
of motor dual task training and cognitive dual task training in children with
cerebral palsy to improve balance in children and reduce their incidence of
fall.
Cerebral palsy (CP) is a group of
disorders that affect a person’s ability to move and maintain balance and
posture. CP is the most common motor disability in childhood. CP is caused by
abnormal brain development or damage to the developing brain that affects a
person’s ability to control his or her muscles.
The prevalence of CP has risen to
well above 2.0 per 1000 live births. In this time span the proportion of
low-birthweight infants rose, the proportion of diplegia decreased, while the
proportion of hemiplegia increased. CP is more prevalent in more deprived
socio-economic populations. The majority of people with CP have the spastic
syndrome of which the diplegic group is the smallest. Dependent on the subgroup
of CP, 25 – 80% have additional impairments.
According to Karolina et al (2020)
patient receiving dual task training have improved balance and functional
mobility children with spastic diplegic cerebral palsy have improved
significantly in the course of 3 weeks.
Inclusion criteria include
Standing independently for at least 30 seconds.
Walking independently with or without an assistive device Understand
protocol and parents give informed consent. Gross motor functional measure I
and II.
Exclusion
criteria includeChildren, who are uncooperativeHave history of epilepsy with
hearing, visual and speech deficit Any cardiac anomalies affecting exercise
tolerance. |