| CTRI Number |
CTRI/2024/10/075731 [Registered on: 23/10/2024] Trial Registered Prospectively |
| Last Modified On: |
20/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of 8 Weeks Online Yoga on middle aged people with Diabetic Neuropathy |
|
Scientific Title of Study
|
Effect of 8 Weeks of Virtual Yoga on Nerve Conduction Parameters, Limits of
Stability and Quality of Life in Middle aged people with Diabetic Neuropathy - A Randomized Control 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 |
Dipali Khade |
| Designation |
Associate Professor |
| Affiliation |
K J Somaiya College of Physiotherapy |
| Address |
Building number B 1/ flat number 15, Ajita complex, Opposite railway subway, Virar east, Palghar
Central research Laboratory (CRL)
K J Somaiya College of Physiotherapy, Eastern express highway, Everard nagar, Sion, Mumbai- 400022
Mumbai (Suburban)
MAHARASHTRA
401305
India |
| Phone |
8767039845 |
| Fax |
|
| Email |
dipalikhade07@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dipali Khade |
| Designation |
Associate Professor |
| Affiliation |
K J Somaiya College of Physiotherapy |
| Address |
Building number B 1/ flat number 15, Ajita complex, Opposite railway subway, Virar east, Palghar
Central research Laboratory (CRL)
K J Somaiya College of Physiotherapy, Eastern express highway, Everard nagar, Sion, Mumbai- 400022
Mumbai (Suburban)
MAHARASHTRA
401305
India |
| Phone |
8767039845 |
| Fax |
|
| Email |
dipalikhade07@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dipali Khade |
| Designation |
Associate Professor |
| Affiliation |
K J Somaiya College of Physiotherapy |
| Address |
Building number B 1/ flat number 15, Ajita complex, Opposite railway subway, Virar east, Palghar
Central research Laboratory (CRL)
K J Somaiya College of Physiotherapy, Eastern express highway, Everard nagar, Sion, Mumbai- 400022
Mumbai (Suburban)
MAHARASHTRA
401305
India |
| Phone |
8767039845 |
| Fax |
|
| Email |
dipalikhade07@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central research Laboratory (CRL)
K J Somaiya College of Physiotherapy, Eastern express highway, Everard nagar, Sion, Mumbai- 400022 |
|
|
Primary Sponsor
|
| Name |
Dipali Khade |
| Address |
B 1/15 AJITA COMPLEX, OPPOSITE RAILWAY SUBWAY, VIRAR EAST, PALGHAR 401305 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| K J Somaiya College of Physiotherapy |
Everard Nagar, Eastern Express Highway, Sion, Mumbai 400022 |
| Parul University Faculty of Physiotherapy |
P. O. Limda, Waghodia, Vadodara, Gujarat 391760 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Dipali Khade PT |
K J Somaiya College of Physiotherapy |
Central research Laboratory (CRL)
K J Somaiya College of Physiotherapy, Eastern express highway, Everard nagar, Sion, Mumbai- 400022
Mumbai (Suburban)
MAHARASHTRA |
8767037845
dipalikhade07@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| K J Somaiya Medical College and Hospital, Mumbai, Institutional Ethics Committee (Academic |
Approved |
| K J Somaiya Medical College and Hospital, Mumbai, Institutional Ethics Committee (Academic) |
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 |
8 weeks of conventional physiotherapy (for the control group) |
frequency - 3 times/week
After initial baseline assessment following would be followed
1. exercises customised according to participant need consisting of specific limb and balance exercises
2. 30 minutes of brisk walking |
| Intervention |
8 weeks of Virtual Yoga |
frequency- 3 times/week
After baseline assessment each participant will follow the following protocol
1. Meditation for 2 minutes
2. Yoga asanas
-Sukshma Vyayam
-Asanas
Standing- Talasana II, Talasana III, Ekpadasana, Utkatasana, Trikonasana
Sitting- Parvatasana II, Parvatasana III, Yogic Mudra, Balasana
Lying- Viparit Karani, Supta Matsyendrasana, Bhujangasana, Savasana
3. Pranayama
- Anulom Vilom
- Bhramari
|
| Comparator Agent |
N/A |
N/A |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosed type 2 Diabetes Mellitus at least for or more than 6 months and having Diabetic neuropathy
2. On medical management and referred for physiotherapy
3. HbA1C values equal or less than 8
|
|
| ExclusionCriteria |
| Details |
1. Any other diagnosed neurological /myogenic / acute cardiovascular / systemic / infective / neoplastic disorder
2. Any lower limb or back related musculoskeletal injury or swelling in lower limbs
3. Pregnancy
4. Alcohol addiction
5. Use of any assistive device to maintain balance
Active participation in active physical activity like Gym, Aerobics or Yoga asanas in past 6 months
6. Presence of ulcers on lower limbs
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Nerve Conduction Study
2. Limits of stability- Centre of pressure analysis, Single leg stance test and Four square step test
3. SF- 12 quality of life questionnaire
|
1. Baseline measurement taken before starting the interventions
2. After 8 weeks completion of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| N/A |
N/A |
|
|
Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
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)
|
01/11/2024 |
| 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)
Modification(s)
|
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
|
1. Participants will be recruited based on the inclusion and exclusion criteria and only after an informed consent is obtained.2. Random allocation of participants will be done. 3. Baseline Assessments would be done followed by grouping as per the allocation and intervention will be started. 4. Intervention as per the two groups would continue for 8 weeks followed by repeat assessments. 5. The data obtained would be analyzed and appropriate statistical tests would be applied and based on the results conclusion would be drawn and discussed along with limitations of the study and suggestions for future research. |