| CTRI Number |
CTRI/2025/12/099816 [Registered on: 24/12/2025] Trial Registered Prospectively |
| Last Modified On: |
17/09/2026 |
| 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
|
Developing and Testing a Somatosensory Training Program for People with Diabetic Peripheral Neuropathy |
|
Scientific Title of Study
|
Development, Validation and Feasibility Testing of a Hip and Ankle Strategy based Somatosensory Training Protocol in Individuals with 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 |
Jatin Sangwan |
| Designation |
PhD Scholar |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala, Haryana, India
Ambala HARYANA 133207 India |
| Phone |
9991266305 |
| Fax |
|
| Email |
jatinphdscholar@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Akanksha Saxena |
| Designation |
Associate Professor |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala, Haryana, India
Ambala HARYANA 133207 India |
| Phone |
7906989678 |
| Fax |
|
| Email |
akankshasaxena623@mmumullana.org |
|
Details of Contact Person Public Query
|
| Name |
Dr Akanksha Saxena |
| Designation |
Associate Professor |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala, Haryana, India
Ambala HARYANA 133207 India |
| Phone |
7906989678 |
| Fax |
|
| Email |
akankshasaxena623@mmumullana.org |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Maharishi Markandeshwar (Deemed to be University) |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation,Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala, Haryana, India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Akanksha Saxena |
Physiotherapy OPD |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, MM(DU), Mullana, Ambala Ambala HARYANA |
9991266305
jatinphdscholar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Maharishi Markandeshwar Institute of Medical Sciences & Research, Mullana, Ambala |
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 |
| Intervention |
Ankle and Hip strategy based Somatosensory Training Protocol |
Training protocol having 14 exercises; 5 for ankle strategy training, 5 for hip strategy training, and 4 exercises focused on both hip and ankle strategy. Each exercise initially perform on the ground, and then on bosu ball for adding somatosensory training component. These exercises will help in improving balance and gait parameters in individuals having diabetic peripheral neuropathy. |
| Comparator Agent |
Diabetic Foot care education and conventional lower extremity exercises |
Diabetic foot care education will be given on 1st day of intervention and conventional lower extremity range of exercises will be given to comparator group. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Pre-diagnosed cases of DPN or Type II diabetes mellitus for 5 years
BMI 18.5 to 29.9 kg per m2
Scored more than 2 out of 13 on Michigan Neuropathy Screening Instrument questionnaire
HbA1C report more then or equal to 6 percent and not older than 3 months
Willing to participate in study |
|
| ExclusionCriteria |
| Details |
Severe Musculoskeletal impairment of lower limb
Any other diagnosed neurological impairment
Severe Retinopathy
Severe Nephropathy
Foot Ulcers
Major Vascular Complication
Unable to walk independently with or without an assistive device |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Vibration perception |
Baseline, 2 week, 4 week, 6 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Proprioception |
Baseline, 2 week, 4 week, 6 week |
| Light touch pressure threshold |
Baseline, 2 week, 4 week, 6 week |
| Balance |
Baseline, 2 week, 4 week, 6 week |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
10/01/2026 |
| 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="8" Days="30" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| 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
|
The study will be conducted in tertiary care Superspeciality hospital in 3 phases; development of protocol, its content validation and feasibility testing. In first phase, based on the literature showing positive effects in improving somatosensory functions and balance, a structured exercise protocol will be developed which incorporates closed chain hip and ankle exercises and somatosensory exercises. In second phases, content validity of exercise protocol was measured and items will be eliminated or revised if score is less after expert’s evaluations. Total 30 participants will be recruited in third phase i.e. feasibility trial by Criterion-Based Purposive sampling method. After signing the consent form, participants will be assessed at baseline, after 2 week, 4 week and 6 week by selected outcome measures. Experimental group receives newly developed hip and ankle strategy-based somatosensory training protocol and conventional group receives hip strengthening exercises, ankle strengthening exercises, and weight bearing activities on unstable surface. Normality will be assessed by Shapiro-wilk test. If p-value is less than 0.05, indicates data is not normally distributed and p-value more than 0.05 indicates data is normally distributed. If the data is distributed normally, parametric tests will be used for within group analysis, between group analysis, and repeated measure analysis. If the data is not normally distributed, non-parametric test will be used. P-value less than 0.05 indicate significant results and more than 0.05 indicate statistical significant results. |