| CTRI Number |
CTRI/2024/10/076054 [Registered on: 29/10/2024] Trial Registered Prospectively |
| Last Modified On: |
07/12/2024 |
| 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
|
Improving Glycemic Regulation and Sensory Integration with specific exercises for the Treatment of Diabetic Peripheral Neuropathy" |
|
Scientific Title of Study
|
Impact of Structured Exercise Programs and Lifestyle Modifications on Glycemic Control in Patients with Type II 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 |
Akanksha Chauhan |
| Designation |
Student |
| Affiliation |
Lovely Professional University |
| Address |
Lovely Professional University Grand Trunk Road Phagwara Punjab
Kapurthala
PUNJAB
144411
India |
| Phone |
8219473966 |
| Fax |
|
| Email |
kaldaikakanksha00@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nandini |
| Designation |
Assistant Professor |
| Affiliation |
Lovely Professional University |
| Address |
Cubicle number 8, Room number 213, Block 4, Department of Physiotherapy, School of Allied Medical Sciences, Lovely Professional University, Phagwara
Kapurthala
PUNJAB
144411
India |
| Phone |
7807564403 |
| Fax |
|
| Email |
nandini.24453@lpu.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Nandini |
| Designation |
Assistant Professor |
| Affiliation |
Lovely Professional University |
| Address |
Cubicle number 8, Room number 213, Block 4, Department of Physiotherapy, School of Allied Medical Sciences, Lovely Professional University, Phagwara
Kapurthala
PUNJAB
144411
India |
| Phone |
7807564403 |
| Fax |
|
| Email |
nandini.24453@lpu.co.in |
|
|
Source of Monetary or Material Support
|
| Lovely Professional University |
|
|
Primary Sponsor
|
| Name |
Akanksha Chauhan |
| Address |
Jalandhar - Delhi, Grand Trunk Rd, Phagwara, Punjab 144411 |
| 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 |
| DR Nandini |
Outpatient department Lovely Professional University |
room number 101 block 3 school of allied medical sciences , Lovely professional university ,Delhi - GT road ,Kapurthala ,Punjab , India pin code 144411
Kapurthala
PUNJAB |
7807564403
nandini24453@lpu.co.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE - LPU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E114||Type 2 diabetes mellitus with neurological complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Experimental Group A |
Cardiovascular programmed exercise protocol
6 days per week for 6 weeks
|
| Comparator Agent |
Experimental Group B |
Cardiovascular programmed exercise
protocol + Sensory integration therapy
6 days per week for 6 weeks
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
• Patients with type 2 diabetes who have diabetic sensorimotor polyneuropathy (DSPN) with a BMI between 25 and 40 kg/m2
• Medication for diabetes and other comorbidities must be consistent for at least three months.
• History of foot ulcer / gangrene
• People above the age of 35 who have Type II Diabetic Neuropathy.
• Participants, who are the residents of the area who visit both off-campus clinical posts and the on-campus outpatient physical therapy clinic (OPD).
|
|
| ExclusionCriteria |
| Details |
Type 1 diabetes or other forms of diabetes
Diabetes consequences that are severe, such as
renal failure
Diabetic with heart disease
Diabetic with cardiovascular disease
Diabetic with retinopathy
Insulin treatment
Elderly
Pregnancy or lactation
Drug addict
Abuse of alcoholic beverages
Current foot ulcer or gangrene illness |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
fasting blood glucose
|
T1 pre intervention
T2 post intervention
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nerve Conduction Velocity |
T1 Pre Intervention
T2 Post Intervention |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
04/11/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
| Duration of intervention | Treatment time | Parameters | | 6 Days/Week | 20 min to 30min/day | Brisk walking knee support pushups, back hand dips with foot support, squatting | Sensory integration | Duration of intervention | Treatment time | Parameters | | 6 days/week | 20 mins to 30 mins/ day | Range of motion exercises Gentle stretching Progressive muscle relaxation exercises Progressive balance training Warm water therapy Resistance training Tactile exploration activities vibration therapy |
|