| CTRI Number |
CTRI/2024/08/073064 [Registered on: 29/08/2024] Trial Registered Prospectively |
| Last Modified On: |
28/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Matrix rhythm therapy on constipation in children with cerebral palsy |
|
Scientific Title of Study
|
Effect of matrix rhythm therapy (marhythe) on chronic functional constipation in children with cerebral palsy : a randomized controlled trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sakshi Sudin Verenker |
| Designation |
Post Graduate student |
| Affiliation |
KAHER institute of physiotherapy |
| Address |
KAHER institute of physiotherapy
Advanced Physiotherapy center room no 39 sagar floor KLE Dr prabhakar kore Hospital
Belgaum
KARNATAKA
590010
India |
| Phone |
9325260199 |
| Fax |
|
| Email |
sakshisverenker@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepa Metgud |
| Designation |
Head of Department of Paediatric Physiotherapy |
| Affiliation |
KAHER institute of physiotherapy |
| Address |
KAHER institute of physiotherapy
Advanced Physiotherapy center room no 39 sagar floor KLE Dr prabhakar kore Hospital
Belgaum
KARNATAKA
590010
India |
| Phone |
9845861236 |
| Fax |
|
| Email |
deepametgud@klekipt.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Sakshi Sudin Verenker |
| Designation |
post graduate student |
| Affiliation |
KAHER institute of physiotherapy |
| Address |
KAHER institute of physiotherapy
Advanced Physiotherapy center room no 39 sagar floor KLE Dr prabhakar kore Hospital
Belgaum
KARNATAKA
590010
India |
| Phone |
9325260199 |
| Fax |
|
| Email |
sakshssverenker@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE Dr Prabhakar kore hospital and research center Nehru nagar Belagavi Karnataka India 590010 |
|
|
Primary Sponsor
|
| Name |
sakshi sudin verenker |
| Address |
Sagar Floor, Advanced Physiotherapy Centre, Room no 39, KLE Dr.Prabhakar Kore Hospital and MRC, Belagavi,Karnataka, 590010 |
| Type of Sponsor |
Other [self sponsored] |
|
|
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 Sakshi verenker |
KAHER institute of Physiotherapy |
Advanced Physiotherapy center, room no 39, sagar floor, KLE Dr prabhakar kore Hospital Belgaum Karnataka 590010 Belgaum Karnataka 590010 India
Belgaum
KARNATAKA
Belgaum
KARNATAKA |
9325260199
sakshisverenker@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Rsearch and Ethical Comittee KAHER Institute of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K00-K95||Diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
laxatives |
laxatives taken, frequency as prescribed by the paediatrician such as mu-out and enema administered by oral or rectal route |
| Intervention |
matrix rhythm therapy |
Matrix Rhythm Therapy, is given by a therapeutic device that is safe to be administered and non-invasive tool..
Matrix rhythm therapy (MRT) works on improving peripheral blood circulation, muscle tone, balance, gait parameters, and sensory functions in various conditions such as burns, stroke survivors, and chronic low back pain.
in this intervention it will be given twice a week, for 2 weeks. each session will be for 45 mins |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Male and female children having Cerebral palsy aged 2-18 years, diagnosed with chronic functional constipation
Children fulfilling the Rome III criteria of functional constipation.
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
constipation assessment scale
bristol stool scale |
at the end of 1st week, 2nd week and 1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Constipation Severity Instrument
Cerebral Palsy Quality of Life Questionnaire |
at the end of 1st week, 2nd week & 1 month |
|
|
Target Sample Size
|
Total Sample Size="11"
Sample Size from India="11"
Final Enrollment numbers achieved (Total)= "22"
Final Enrollment numbers achieved (India)="22" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/09/2024 |
| Date of Study Completion (India) |
18/03/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
18/04/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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) often leads to constipation due to factors like immobility, medication use, and dietary issues, significantly affecting the quality of life for children and caregivers. This study aims to evaluate the effectiveness of combining Matrix Rhythm Therapy (MRT) with laxatives for managing chronic functional constipation in children with CP, given MRT’s potential benefits in improving physiological functions. |