| CTRI Number |
CTRI/2024/04/065798 [Registered on: 16/04/2024] Trial Registered Prospectively |
| Last Modified On: |
13/04/2024 |
| 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
|
Comparison of Uphill Walking Versus Retro Walking on Subjects with Knee Osteoarthritis. |
|
Scientific Title of Study
|
Comparison of Uphill Walking Versus Retro Walking on Knee Symptom,Physical functions, kinesiophobia and Psychometric Affection in Subjects with knee Oestoarthritis. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anisha |
| Designation |
MPT Student |
| Affiliation |
Guru Jambheshwar University Science And Technology,Hisar |
| Address |
OPD,Room
No-7,Department Of
Physiotherapy
Guru Jambheshwar
University of Science
and Technology,
Hisar-Delhi Bypass Rd,
Hisar (Haryana)125001
Hisar
HARYANA
125001
India |
| Phone |
9416979456 |
| Fax |
|
| Email |
doctoranishasingh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shabnam Joshi |
| Designation |
Professor |
| Affiliation |
Guru Jambheshwar University Science And Technology,Hisar |
| Address |
OPD,Room
No-7,Department Of
Physiotherapy
Guru Jambheshwar
University of Science
and Technology,
Hisar-Delhi Bypass Rd,
Hisar (Haryana)125001
Hisar
HARYANA
125001
India |
| Phone |
9729922466 |
| Fax |
|
| Email |
shabnamphysio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Alka Pawalia |
| Designation |
Assistant Professor |
| Affiliation |
Guru Jambheshwar University Science And Technology Hisar |
| Address |
OPD,Room
No-7,Department Of
Physiotherapy
Guru Jambheshwar
University of Science
and Technology,
Hisar-Delhi Bypass Rd,
Hisar (Haryana)125001
Hisar
HARYANA
125001
India |
| Phone |
9468349944 |
| Fax |
|
| Email |
alkapawalia@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD,Room
No-7,Department Of
Physiotherapy
Guru Jambheshwar
University of Science
and Technology,
Hisar-Delhi Bypass Rd,
Hisar (Haryana)125001
Hisar
HARYANA |
|
|
Primary Sponsor
|
| Name |
Anisha |
| Address |
Department of Physiotherapy Guru Jambheshwar University Science And Technology,Hisar, Haryana |
| 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 |
| DrAnisha |
Guru Jambheshwar University of Science and Technology, Hisar-Delhi Bypass Rd, Hisar (Haryana)125001 |
OPD,Room No-7,Department Of Physiotherapy ,Guru Jambheshwar University of Science and Technology, Hisar-Delhi Bypass Rd, Hisar (Haryana)125001
Hisar
HARYANA |
9416979456
doctoranishasingh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee,Department of Physiotherapy GJUS and T Hisar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Retro Walking |
GROUP-B(Retro Walking) -Hot pack for 10 minutes -warm up (5 minutes) -Retro-walking (10 minutes) -cool down (5 minutes) -Over a four-week period, participants will be told to gradually extend the duration of their walking up to 20 minutes. |
| Intervention |
Uphill Walking |
GROUP-A(Uphill Walking)
-Hot pack for 10 minutes
-warm up (5 minutes)
-Uphill walking (10 minutes)
1.13 m/s walking speed with 8-degree inclination.
-cool down (5 minutes)
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1)Diagnosis confirmation of knee osteoarthritis according to American College of Rheumatology Criteria
2)Age 40-65 years |
|
| ExclusionCriteria |
| Details |
Any history of knee injury
History of knee joint replacement
History of fracture in past 6 months (lower limb)
History of Cancer
Corticosteroid injection in knee
Pregnancy
Systemic disease
Rheumatoid arthritis
|
|
|
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 Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain
Physical function
Dynamic balance
Q angle
Hamstring flexibility
Kinesiophobia
Psychometric affection
|
At Baseline and after 4 weeks of intervention
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Walking velocity
knee and Ankle ROM
|
At Baseline and after 4 weeks of intervention
|
|
|
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)
|
25/04/2024 |
| 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="3"
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
|
Osteoarthritis (OA) is a degenerative joint disease of the knee and is among one of the most disabling diseases in the world. Knee pain that gradually develops and gets worse with movement accompanied by knee stiffness, swelling and discomfort after extended periods of sitting or sleeping. Walking programs such as uphill walking and retro walking are less intensive close kinetic chain exercises which are closely related to our daily life activities. Walking programs are also cost effective, non-pharmacological and accessible intervention for large population. There are several studies which shows effectiveness of uphill walking and retro walking on patients with knee osteoarthritis but no study has been conducted till now which compares the effect of uphill walking and retro walking. Therefore, the purpose of this study is to compare the efficacy of uphill walking and retro walking on Pain, Physical function, Kinesiophobia, Psychometric affection, Q- angle, Dynamic balance, Hamstring flexibility and Knee and Ankle ranges in patients with knee osteoarthritis.
|