| CTRI Number |
CTRI/2025/04/084248 [Registered on: 07/04/2025] Trial Registered Prospectively |
| Last Modified On: |
04/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
A study comparing the effects of two interventions combined with treadmill walking on balance improvement in individuals with Diabetic Nerve damage |
|
Scientific Title of Study
|
Comparative Analysis of Sensorimotor Training and Whole Body Vibration Training in conjunction with Aerobic Exercise in balance among Diabetic Peripheral Neuropathy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sheela Angel I |
| Designation |
Lecturer in Physiotherapy |
| Affiliation |
National Institute for Empowerment of persons with Multiple Disabilities |
| Address |
College of Physiotherapy-NIEPMD(D)
Department of Therapeutics-Physiotherapy division
Gplus7 building,III floor,Room no:14
ECR
Muttukadu
Chennai
Chennai
TAMIL NADU
603112
India |
| Phone |
8681050384 |
| Fax |
|
| Email |
isheelaangel@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M Sandhiya |
| Designation |
Assistant Professor |
| Affiliation |
Vels Institute of Science Technology and Advanced Studies(VISTAS) |
| Address |
School of Physiotherapy
Vels Institute of Science Technology and Advanced Studies(VISTAS)
Department of Physiotherapy,II floor,Room no.3
Thalambur
Chennai
TAMIL NADU
600130
India |
| Phone |
9940583928 |
| Fax |
|
| Email |
sandhiya.sp@vistas.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sheela Angel I |
| Designation |
Research Scholar |
| Affiliation |
Vels Institute of Science Technology and Advanced Studies(VISTAS) |
| Address |
School of Physiotherapy
Vels Institute of Science Technology anSchool of Physiotherapy
Vels Institute of Science Technology and Advanced Studies(VISTAS)
Department of Physiotherapy,
II floor,Room no.5
Thalambur Advanced Studies(VISTAS)
Thalambur
School of Physiotherapy
Vels Institute of Science Technology and Advanced Studies(VISTAS)
Department of Physiotherapy,II floor,Room no.5
Thalambur
Chennai
TAMIL NADU
600130
India |
| Phone |
9940529897 |
| Fax |
|
| Email |
isheelaangel@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Isari Velan Mission Hospital -Department of Physiotherapy
Ground Floor,Room Number:4,Vels College Road,Thalambur-600130. |
|
|
Primary Sponsor
|
| Name |
Sheela Angel I |
| Address |
No:18/35 South Street,V.P Colony,Ayanavaram.Chennai-600023 |
| Type of Sponsor |
Other [this study is sponsored by the Principal Investigator] |
|
|
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 |
| Sheela Angel I |
Shri Isari Velan Mission Hospital |
Ground Floor,Room no.4
Department of Physiotherapy
Vels College Road
Thalambur
Chennai-600130
Chennai
TAMIL NADU |
9940529897
isheelaangel@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| VISTAS SPS IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Diabetic Peripheral Neuropathy individuals |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Sensorimotor Training along with Aerobic Exercise |
For 8 weeks,this group subjects will perform sensorimotor training along with aerobic exercise. sensorimotor exercise will be given in static,Dynamic and Functional in order .then Aerobic exercise will be given through Treadmill training |
| Comparator Agent |
Standard Care |
Subjects in this group will receive Standard Care.
Duration-For 8 weeks |
| Intervention |
Whole Body Vibration Training along with Aerobic Exercise |
Subjects in this group will receive Whole Body Vibration Training in conjunction with Aerobic Exercise .
Duration -for 8 weeks. |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Subjects who have been diagnosed by Diabetologist as Type II Diabetes Mellitus for greater than 8 years with Diabetic Neuropathy
Without any episode of plantar ulceration or amputation
Subjects who were able to follow the instructions
Ability to walk independently
|
|
| ExclusionCriteria |
| Details |
Any other neurological impairment
Musculoskeletal impairments
Postural hypotension
Intellectual disabilities or Psychiatric disorders |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Berg Balance Scale(BBS) |
At Baseline
After 8 weeks
After 12 weeks(follow up) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Quality of Life -SF 36 questionnaire
Aerobic Capacity-3 min Step test (Harvard step test)
Vibratory Perception Threshold-Biothesiometry |
At Baseline
After 8 weeks
After 12 weeks(follow up) |
|
|
Target Sample Size
|
Total Sample Size="129"
Sample Size from India="129"
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)
|
15/04/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Diabetic Peripheral Neuropathy (DPN) is a common complication of Type II Diabetes, leading to impaired balance, increased fall risk, and reduced quality of life. This quasi experimental study aims to compare the effects of Sensorimotor Training (SMT) and Whole-Body Vibration (WBV) Training, both combined with Aerobic Exercise, on balance and functional outcomes in individuals with DPN.The study seeks to determine which training method—SMT or WBV—is more effective in enhancing postural control, functional mobility, and overall well-being in individuals with DPN. Findings could contribute to optimizing rehabilitation strategies for balance impairments in diabetic patients. |