| CTRI Number |
CTRI/2024/09/073809 [Registered on: 12/09/2024] Trial Registered Prospectively |
| Last Modified On: |
11/09/2024 |
| 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
|
Pelvic Floor Muscle Biofeedback Device |
|
Scientific Title of Study
|
Design, Development and Testing of Home-Based Non-Invasive Pelvic Floor Muscle Rehabilitation Device:
A Multiphasic Exploratory 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 |
Ruchi Sanjaykumar Bhuva |
| Designation |
Post Graduate Student |
| Affiliation |
School of Physiotherapy, RK University |
| Address |
Research Department, Room no. 207, School of Physiotherapy, RK
University kasturbadham Rajkot-Bhavnagar Highway, Rajkot,
Gujarat, India.
Rajkot
GUJARAT
360020
India |
| Phone |
7490815411 |
| Fax |
|
| Email |
rbhuva664@rku.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Krupa Harikrishna Tank MPT PhD Scholar |
| Designation |
Assistant Professor, School of Physiotherapy, RK University |
| Affiliation |
School of Physiotherapy, RK University |
| Address |
Research Department, Room no. 207, School of Physiotherapy, RK
University kasturbadham Rajkot-Bhavnagar Highway, Rajkot,
Gujarat, India.
Rajkot
GUJARAT
360020
India |
| Phone |
9998810063 |
| Fax |
|
| Email |
krupa.tank@rku.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Ruchi Sanjaykumar Bhuva |
| Designation |
Post Graduate Student |
| Affiliation |
School of Physiotherapy, RK University |
| Address |
Research Department, Room no. 207, School of Physiotherapy, RK
University kasturbadham Rajkot-Bhavnagar Highway, Rajkot,
Gujarat, India.
Rajkot
GUJARAT
360020
India |
| Phone |
7490815411 |
| Fax |
|
| Email |
rbhuva664@rku.ac.in |
|
|
Source of Monetary or Material Support
|
| Ruchi Sanjaykumar Bhuva, School of Physiotherapy, RK University, Kasturbadham, Rajkot-Bhavnagar Highway, Rajkot, Gujara |
|
|
Primary Sponsor
|
| Name |
Ruchi Sanjaykumar Bhuva |
| Address |
School of Physiotherapy , RK University, Kasturbadham ,
Rajkot-Bhavnagar Highway, Rajkot-360020, Gujarat, India |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Ruchi Sanjaykumar Bhuva |
RK Physiotherapy Rehabilitation and Research Center |
Physiotherapy Department, Room no. 1, Opp. Meghani Rang Bhavan, Bhaktinagar Circle, Rajkot- 360020, Gujarat, India.
Rajkot
GUJARAT |
07490815411
rbhuva664@rku.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, School of Physiotherapy, RK University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
EMG Biofeedback |
this device includes biofeedback of the muscle activity used by physical therapist. It will be given before and after 2 weeks of treatment. |
| Intervention |
Pelvic Floor Muscle Biofeedback Device |
This biofeedback device will help to strengthen and control their pelvic floor muscles activity. It will be given before and after 2 weeks of treatment. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Adults (25 years to 80 years of age group)
2. Patient with pelvic floor dysfunction (urinary 3. incontinence, pelvic organ prolapse, post-prostatectomy incontinence)
Male and Female
|
|
| ExclusionCriteria |
| Details |
1. Recent pelvic surgery
2. Pregnancy
3. Severe cognitive impairment
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
PFDI (Pelvic floor dysfunction inventory) – 20
|
Baseline and after 2 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quest 2.0 |
After Completion of Intervention. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 3 |
|
Date of First Enrollment (India)
|
02/12/2024 |
| 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="3"
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
|
Title: Design, Development and Testing of Home-Based Non-invasive Pelvic Floor Muscle Rehabilitation Device : A Multiphasic Exploratory Study.
Investigator: Ruchi Bhuva PT, Krupa Tank PhD scholar, MPT
Background:
The pelvic floor muscles are crucial for maintaining continence, sexual function, and supporting pelvic organs. These muscles can weaken due to factors like pregnancy, aging, obesity, and certain medical conditions. Weak pelvic floor muscles are associated with issues such as urinary and fecal incontinence, pelvic organ prolapse, sexual dysfunction, and other issues. Low anterior resection syndrome (LARS) affects 80% of patients after rectal cancer surgery. Which include altered bowel frequency, irregular bowel rhythms, fecal incontinence, and constipation. Urinary incontinence (UI) is a common health problem that has been paid more and more attention to all over the world. The most common type was stress UI (SUI). UI afflicts at least 21.6% of the global population. In response to this, a user-friendly, home-based non-invasive biofeedback device could provide a biofeedback for strengthening pelvic floor muscles and improving overall quality of life.
Method: Phase 1 - Designing of device
Phase 2 - Development of device
Phase 3 - Testing of device
|