| CTRI Number |
CTRI/2025/09/095451 [Registered on: 29/09/2025] Trial Registered Prospectively |
| Last Modified On: |
26/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Impact of Foot Muscle Energy Technique on Plantar Pressure in Patients with Diabetic Neuropathy: A Randomized Controlled Trial |
|
Scientific Title of Study
|
Effect of Foot Muscle Energy Technique on Plantar Pressure in Patients with Diabetic Neuropathy: A Randomized Controlled 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 |
Mugdha Pendse |
| Designation |
Post graduate student |
| Affiliation |
Kle institute of Physiothrapy |
| Address |
OPD no 6 CVTS Physiotherapy
Kle Institute of Physiotherapy , Belagavi, Karanataka 590010
JNMC camous , Nehru Nagar , Belaavi- 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
09765391857 |
| Fax |
|
| Email |
mugdu08pendse@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ganesh BR |
| Designation |
Professor and Head of CVTS department |
| Affiliation |
Kle institute of Physiothrapy |
| Address |
Kle Institute of Physiotherapy , Belagavi, Karanataka 590010
JNMC camous , Nehru Nagar , Belaavi- 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
09765391857 |
| Fax |
|
| Email |
drganeshnssofficer@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mugdha Pendse |
| Designation |
Post graduate student |
| Affiliation |
Kle institute of Physiothrapy |
| Address |
Kle Institute of Physiotherapy , Belagavi, Karanataka 590010
JNMC camous , Nehru Nagar , Belaavi- 590010
KARNATAKA
590010
India |
| Phone |
09765391857 |
| Fax |
|
| Email |
mugdu08pendse@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kles Dr. Prabhakar kore hospital, Nehru Nagar Belagavi, Karnataka, India- 590100 |
|
|
Primary Sponsor
|
| Name |
Mugdha Pendse |
| Address |
Kle Institute of Physiotherapy, Belagavi |
| 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 |
| Mugdha Pendse |
DR. PRABHAKAR KORE HOSPITAL |
JNMC Campus, Nehru Nagar, Belagavi, Karntaka-590010
Belgaum
KARNATAKA |
09765391857
mugdu08pendse@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KAHER Istitute of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Diabetic Neuropathy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Joint mobility exercise , Strength Training and Sensory Intergration |
Active ROM: Ankle dorsiflexion-plantarflexion,
ankle inversion-eversion, toe flexion-extension
Dynamic Stretches: Calf stretch ( standing),
plantar fascia stretch (toe dorsiflexion using towel)
Intrinsic Foot Muscle Strengthening: Toe curls using marbles/towel scrunching, short foot exercise (lifting the arch)
Ankle Strengthening: Thera-band exercises (ankle dorsiflexion, plantarflexion, inversion, eversion), seated heel raises (90-90 position)
• Sensory Integration
1. Tactile Stimulation
-Walking on different surfaces
- Vibration therapy
- Brushing
2. Proprioceptive Training
- Balance exercises
- Weight shifting drills
|
| Intervention |
Muscle enegry technique and sensory integration |
• Muscle energy technique
Frequency: 3 Sessions per week
3-5 repetition ,
Intensity : 7-10 sec hold with 20% of active participation
Time : 15-20 mins
Type: Isometric contraction followed by passive stretching
Muscles: Tibialis Anterior
Gastrocnemius, Soleus, Tibialis Posterior ,Tibialis Posterior
Peroneus Longus & Brevis
Toe Flexors (Flexor Hallucis Longus, Flexor Digitorum Longus)
Toe Extensors (Extensor Hallucis Longus, Extensor Digitorum Longus)
• Sensory Integration
1. Tactile Stimulation
-Walking on different surfaces
- Vibration therapy
- Brushing
2. Proprioceptive Training
- Balance exercises
- Weight shifting drills
|
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Type 2 Diabetes Mellitus for at least 10 years and diagnosed with Moderate Diabetic Peripheral Neuropathy (DPN).(according to Toronto clinical system for Diabetic Neuropathy).Hba1c level more than or equal to 8.5 percent.Presence of altered plantar pressure distribution but no active foot ulcers.Walk independently and those who are willing to participate |
|
| ExclusionCriteria |
| Details |
Amputation History
Severe Neuropathy
Severe Foot deformity
Recent Lower Limb Surgery or Fractures |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Plantar Pressure using KODEYS FootWork® Néo
Foot Function Index
|
4 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Plantar Pressure using KODEYS FootWork® Néo
Foot Function Index
|
4 week |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
08/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
08/10/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
This thesis investigates the effect of physiotherapy interventions on plantar pressure distribution in patients with diabetic peripheral neuropathy (DPN). Abnormal plantar pressures, particularly elevated forefoot and heel loading, are a major risk factor for foot ulceration in diabetes. The study compares the effectiveness of muscle energy technique (MET) for intrinsic and extrinsic foot muscles against conventional strengthening and mobility exercises. Outcome measures include plantar pressure mapping assessed using Kodey’s Foot Scanner device, providing objective quantification of pressure changes pre- and post-intervention. The intervention period spans four weeks with thrice-weekly sessions in the outpatient department. The study aims to determine whether targeted physiotherapy can normalize plantar pressure, improve foot biomechanics, and reduce ulceration risk, thereby contributing to preventive diabetic foot care strategies. |