| CTRI Number |
CTRI/2024/11/076800 [Registered on: 14/11/2024] Trial Registered Prospectively |
| Last Modified On: |
12/11/2024 |
| 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
|
Effectiveness of Foot-Ankle strengthening exercises on Knee Osteoarthritis |
|
Scientific Title of Study
|
Effect of foot-ankle strengthening exercises on pain, range of motion and functional performance in patients with symptomatic knee osteoarthritis. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Muskan Jain |
| Designation |
MPT Student |
| Affiliation |
Mahatma Gandhi University of Medical Sciences and Technology, Jaipur |
| Address |
Physiotherapy Ortho Lab, department of physiotherapy, Mahatma Gandhi Physiotherapy College, RIICO Institutional Area, Sitapura, Tonk Road
Jaipur
RAJASTHAN
302022
India |
| Phone |
7014179941 |
| Fax |
|
| Email |
muskan2003@mgumst.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saleem Akhtar Naqvi |
| Designation |
Professor and Head Physiotherapy clinicals |
| Affiliation |
Mahatma Gandhi University of Medical Sciences and Technology, Jaipur |
| Address |
Mahatma Gandhi Physiotherapy College, Mahatma Gandhi University of medical sciences and technology, RIICO Institutional Area, Sitapura, Tonk Road, Jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
9680154007 |
| Fax |
|
| Email |
physio.sallu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saleem Akhtar Naqvi |
| Designation |
Professor and Head Physiotherapy clinicals |
| Affiliation |
Mahatma Gandhi University of Medical Sciences and Technology, Jaipur |
| Address |
Mahatma Gandhi Physiotherapy College, Mahatma Gandhi University of medical sciences and technology, RIICO Institutional Area, Sitapura, Tonk Road, Jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
9680154007 |
| Fax |
|
| Email |
physio.sallu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Physiotherapy College, Mahatma Gandhi University of Medical Sciences and Technology, RIICO Institutional Area, Sitapura, Tonk Road, Jaipur, Rajasthan (India), 302022 |
|
|
Primary Sponsor
|
| Name |
Muskan Jain |
| Address |
41 Chitrakut Colony behind Eternal Hospital Sanagner, Sanganer, Jaipur, Rajasthan (India) 302029 |
| 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 Saleem Akhtar Naqvi |
Mahatma Gandhi Hospital, Jaipur |
Room no. 14
,Physiotherapy OPD,
Basement.
Jaipur
RAJASTHAN
Jaipur
RAJASTHAN |
9680154007
physio.sallu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee, Mahatma Gandhi Medical college and Hospital,MGUMST, Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Physiotherapy |
Conventional physiotherapy: Ultrasound Therapy, knee strengthening exercises and stretching (Hamstrings, calf and hip flexors).
Treatment would be done under supervision with consent.
The total duration of the treatment program will be of 4 weeks. Foot-Ankle strengthening exercises and conventional exercises will be performed twice daily, with 10 repetitions in 3 sets in a session with 10-20 seconds hold, 1 minute rest time between sets. Ultrasound therapy will be given as 4 sessions in a week, each session will be of 5 minutes. |
| Intervention |
Strengthening of foot-ankle muscles along with conventional physiotherapy. |
Foot-Ankle strengthening exercises: involving isolated strengthening of extrinsic and intrinsic foot- ankle muscles, and of strengthening and functional training of extrinsic and intrinsic foot- ankle muscles.
Conventional physiotherapy: Ultrasound Therapy, knee strengthening exercises and stretching (Hamstrings, calf and hip flexors).
Treatment would be done under supervision with consent.
The total duration of the treatment program will be of 4 weeks. Foot-Ankle strengthening exercises and conventional exercises will be performed twice daily, with 10 repetitions in 3 sets in a session with 10-20 seconds hold, 1 minute rest time between sets. Ultrasound therapy will be given as 4 sessions in a week, each session will be of 5 minutes. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Case of symptomatic Osteoarthritis Knee Kellgren_Lawrence grade-1,2,3
Knee pain in range of 30mm-70mm(3-7) on VAS
|
|
| ExclusionCriteria |
| Details |
Traumatic Knee Injury/ fracture
Having received steroid and hyaluronic acid intra-articular knee injections in the previous
3 and 6 months, respectively.
History of knee, ankle or hip surgery in the last 2 years.
Neurological illness or deficit
Inflammatory arthritis (e.g., rheumatoid arthritis).
Asymptomatic Knee Osteoarthritis in one or both knees.
Open Wounds / Ulcerations
Skin infections
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Visual Analogue Scale (VAS)
Goniometer
Western Ontario and McMaster Universities Arthritis Index (WOMAC) |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Visual Analogue Scale (VAS) |
2 weeks |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
25/11/2024 |
| 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="0"
Months="4"
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
|
PROCEDURE
The
eligibility criteria of the candidate will be taken from the basis of inclusion
criteria.
50 samples will be categorized into two groups with 25
individuals in each group and will be studied for 4 weeks.
Group- A: Foot-Ankle strengthening
exercises + conventional physiotherapy.
Group-
B: conventional physiotherapy. Group-A
Foot-Ankle strengthening exercises: involving isolated
strengthening of extrinsic and intrinsic foot- ankle muscles, and of
strengthening and functional training of extrinsic and intrinsic foot- ankle
muscles.
Conventional physiotherapy: Ultrasound Therapy, knee strengthening
exercises and stretching (Hamstrings, calf and hip flexors).
Group- B
Conventional physiotherapy: Ultrasound Therapy, knee strengthening
exercises and stretching (Hamstrings, calf and hip flexors).
Treatment
would be done under supervision with consent. The total duration of the treatment program will
be of 4 weeks. Foot-Ankle strengthening exercises and conventional exercises
will be performed twice daily, with 10 repetitions in 3 sets in a session with
10-20 seconds hold, 1 minute rest time between sets. Ultrasound therapy will be
given as 4 sessions in a week, each session will be of 5 minutes. The Western Ontario and McMaster Universities Arthritis
Index (WOMAC) will be given to patients before & after the treatment, &
will be used as a primary outcome measure. Pain will be assessed by using
Visual Analogue Scale (VAS) & Range of Motion of the joint will be assessed
by Goniometer.
|