| CTRI Number |
CTRI/2025/09/093975 [Registered on: 01/09/2025] Trial Registered Prospectively |
| Last Modified On: |
29/08/2025 |
| 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
|
Emg biofeedback in Gluteus Medius training |
|
Scientific Title of Study
|
Effectiveness of Emg biofeedback in Gluteus Medius training in reducing pain, improving muscle strength and functional activities in unilateral plantar fasciitis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DEEPIKA S |
| Designation |
Pg resident |
| Affiliation |
College of Physiotherapy, Sri Ramakrishna Institute of Paramedical Sciences |
| Address |
3rd floor, 2nd room, College of Physiotherapy, Sri Ramakrishna Institute of Paramedical Sciences, 395, Sarojini Naidu Road, Sidhapudur, Coimbatore
Coimbatore
TAMIL NADU
641044
India |
| Phone |
9585517684 |
| Fax |
|
| Email |
deepikasundar2809@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
V S SEETHARAMAN |
| Designation |
Principal |
| Affiliation |
College of Physiotherapy, Sri Ramakrishna Institute of Paramedical Sciences |
| Address |
3rd floor, 2nd room, College of Physiotherapy, Sri Ramakrishna Institute of Paramedical Sciences, 395, Sarojini Naidu Road, Sidhapudur, Coimbatore
Coimbatore
TAMIL NADU
641044
India |
| Phone |
9842744406 |
| Fax |
|
| Email |
principal@sripmsphysio.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
V S SEETHARAMAN |
| Designation |
Principal |
| Affiliation |
College of Physiotherapy, Sri Ramakrishna Institute of Paramedical Sciences |
| Address |
3rd floor, 2nd room, College of Physiotherapy, Sri Ramakrishna Institute of Paramedical Sciences, 395, Sarojini Naidu Road, Sidhapudur, Coimbatore
Coimbatore
TAMIL NADU
641044
India |
| Phone |
9842744406 |
| Fax |
|
| Email |
principal@sripmsphysio.ac.in |
|
|
Source of Monetary or Material Support
|
| 3rd floor, 2nd room, College of Physiotherapy, Sri Ramakrishna Institute of Paramedical Sciences, 395, Sarojini Naidu Road, Sidhapudur, Coimbatore- 641044 |
|
|
Primary Sponsor
|
| Name |
DEEPIKA S |
| Address |
3rd floor, 2nd room, College of Physiotherapy, Sri Ramakrishna Institute of Paramedical Sciences, 395, Sarojini Naidu Road, Sidhapudur, Coimbatore- 641044 |
| 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 |
| V S SEETHARAMAN |
Sri Ramakrishna Hospital (Multi- Speciality) |
Department of Physiotherapy, 395, Sarojini Naidu Road, Sidhapudur, Coimbatore, 641044
Coimbatore
TAMIL NADU |
9842744406
principal@sripmsphysio.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Ramakrishna Hospital Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Gluteus Medius training |
35 Minutes Of Treatment Duration, 5 Days Per Week For 3 Weeks Single Session Per Day (15 Sessions) For Each Subject. |
| Comparator Agent |
Gluteus Medius training with Emg biofeedback |
35 Minutes Of Treatment Duration, 5 Days Per Week For 3 Weeks Single Session Per Day (15 Sessions) For Each Subject. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patient diagnosed with plantar fasciitis, NPRS of 5 on 10, pain on medial calcaneal tuberosity, flat foot, bmi- 18-24, discomfort with activity after rest, continuous standing for 4 hours |
|
| ExclusionCriteria |
| Details |
Past history of localized corticosteroid injection, Acute ankle sprain, Metatarsalgia, Ta tendinitis, Hallux valgus, Hammer toe, Excessive lumbar lordosis, Lscs, Post operative surgeries in lower limb, Any pathologies which elicit heel pain, Painful condition affecting hip and knee joint, Psychological problems |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Numerical Pain Rating Scale
2.Foot Function Index
3. Hand Held Dyanamometer |
6 months |
|
|
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)
|
10/09/2025 |
| 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="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
|
•Plantar fasciitis is one of the most common causes of heel pain, often resulting from biomechanical dysfunction, particularly poor hip and pelvic stability due to Gluteus Medius weakness. Recent rehabilitation approaches have explored proximal muscle strengthening to alleviate stress on the plantar fascia. EMG biofeedback provides real-time monitoring and guidance for muscle activation, potentially enhancing neuromuscular control and functional outcomes. •Objective:
To evaluate the effectiveness of EMG biofeedback-assisted Gluteus Medius training in reducing pain, improving muscle strength, and enhancing functional activity in patients with unilateral plantar fasciitis. •Methods:
A total of 30 participants clinically diagnosed with unilateral plantar fasciitis were randomly assigned to two groups. Group A received Gluteus Medius strengthening exercises combined with conventional therapy and laser treatment, while Group B received EMG biofeedback-guided Gluteus Medius training alongside the same conventional and laser therapy. The intervention lasted three weeks (five sessions per week, 35 minutes per session). Pain, strength, and functional performance were assessed using the Numerical Pain Rating Scale (NPRS), Foot Function Index (FFI), and a hand-held dynamometer. Plantar fasciitis is one of the most common causes of heel pain, often resulting from biomechanical dysfunction, particularly poor hip and pelvic stability due to Gluteus Medius weakness. Recent rehabilitation approaches have explored proximal muscle strengthening to alleviate stress on the plantar fascia. EMG biofeedback provides real-time monitoring and guidance for muscle activation, potentially enhancing neuromuscular control and functional outcomes. •Objective:
To evaluate the effectiveness of EMG biofeedback-assisted Gluteus Medius training in reducing pain, improving muscle strength, and enhancing functional activity in patients with unilateral plantar fasciitis. •Methods:
A total of 30 participants clinically diagnosed with unilateral plantar fasciitis were randomly assigned to two groups. Group A received Gluteus Medius strengthening exercises combined with conventional therapy and laser treatment, while Group B received EMG biofeedback-guided Gluteus Medius training alongside the same conventional and laser therapy. The intervention lasted three weeks (five sessions per week, 35 minutes per session). Pain, strength, and functional performance were assessed using the Numerical Pain Rating Scale (NPRS), Foot Function Index (FFI), and a hand-held dynamometer. |