| CTRI Number |
CTRI/2022/09/045236 [Registered on: 06/09/2022] Trial Registered Prospectively |
| Last Modified On: |
05/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
To compare the effect of task oriented balance training and sensory motor training on balance in diabetic peripheral neuropathy |
|
Scientific Title of Study
|
Comparison of task oriented balance training and sensory motor training on balance in diabetic peripheral neuropathy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Soumya saswati panigrahi |
| Designation |
MPT NEUROLOGY |
| Affiliation |
SRM COLLEGE OF PHYSIOTHERAPY |
| Address |
SRM College of physiotherapy,SRM Nagar, KATTANKULATHUR, Tamilnadu
SRM College of physiotherapy,SRMIST,SRM Nagar, KATTANKULATHUR, Tamilnadu
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
7978728683 |
| Fax |
|
| Email |
soumyasaswatipanigrahi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
R P Shanmugapriya |
| Designation |
Assistant professor |
| Affiliation |
SRM COLLEGE OF PHYSIOTHERAPY |
| Address |
SRM College Of physiotherapy,SRM Institute of science and technology,SRM Nagar, KATTANKULATHUR, kancheepuram, tamilnadu
SRM College Of physiotherapy,SRM Institute of science and technology,SRM Nagar, KATTANKULATHUR,
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9629398757 |
| Fax |
|
| Email |
rpshanmugapriyapt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
R P Shanmugapriya |
| Designation |
Assistant professor |
| Affiliation |
SRM COLLEGE OF PHYSIOTHERAPY |
| Address |
SRM College Of physiotherapy,SRM Institute of science and technology,SRM Nagar, KATTANKULATHUR, kancheepuram, tamilnadu
SRM College Of physiotherapy,SRM Institute of science and technology,SRM Nagar, KATTANKULATHUR,
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9629398757 |
| Fax |
|
| Email |
rpshanmugapriyapt@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
|
|
Primary Sponsor
|
| Name |
Soumya saswati panigrahi |
| Address |
At/po-Nuapatna, Tigiria Cuttack Odisha 754035 |
| Type of Sponsor |
Other [Self funder] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
SRM INSTITUTE OF SCIENCE AND TECHNOLOGY
SRM NAGAR KATTANKULATHUR |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Soumya Saswati Panigrahi |
SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
DEPARTMENT OF GENERAL MEDICINE MALE AND FEMALE WARD, DEPARTMENT OF NEUROMEDICINE, SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE,603203,
Kancheepuram
TAMIL NADU |
7978728683
soumyasaswatipanigrahi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM medical College hospital and research centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G64||Other disorders of peripheral nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Sensorimotor training |
Sensory motor training include 10 min warmup, followed by 45-60min exercise then 5-10 mins of cooldown. Warm up activity will include mild stretching and jogging, sensorimotor training will include wall slide, core exercise, balance exercises on unstable surface, cooldown activity will include deep breathing abdominal breathing and relaxation.
|
| Intervention |
Task orientation balance training |
Task oriented balance training which will include stepping up and down in different direction to strengthen the lower limb muscle to increase control over shifts in the COG, heel raise to increase strength of plantar flexor, semi squat, walking across a surface full of obstacles to improve dynamic balance, static standing with counting backwards |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age 50-65years
Both men & women
Clinically diagnosed with diabetic peripheral neuropathy Berg Balance Score > 20.
DPN score<9(Moderate and severe) |
|
| ExclusionCriteria |
| Details |
Recent lower limb Fractures
Visually Challenged
Other neurological conditions
Diabetic foot ulcer grading 2-5
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement of the balance |
8weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
08/09/2022 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not applicable |
|
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) occurs in 40%–59% of the total diabetic population. Balance and gait are more affected in diabetic peripheral neuropathy patients than the patients with diabetes. Reduce balance ability cause increased risk of fall in diabetic peripheral neuropathy. Task oriented balance training and sensorimotor training were proved to be effectively addressing the balance impairment in patients with diabetic neuropathy. Based on the inclusion criteria, those who are voluntarily willing to participate with informed consent, the whole procedure will be explained to the subjects and the balance of every subjects will be assessed using Berg Balance Scale, Functional Reach Test and Time Up and Go test. The selected samples will be divided into 2 groups, one group will be receiving task oriented balance training and other group will be receiving sensorimotor training. Both the groups will be receiving 1 session (45-60 mins) per day for 4days in a week, totally for 8 weeks. |