CTRI/2023/08/056593 [Registered on: 17/08/2023] Trial Registered Prospectively
Last Modified On:
27/04/2026
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
Effect of addition of Backward walking to traditional treatment on pain, balance, walking pattern, strength, flexibility, disability and mobility in patients with Knee pain
Scientific Title of Study
Effect of Retro walking as an Adjunct to conventional treatment on Pain, Balance, Gait, Muscle strength, Flexibility, Functional disability and Mobility in patients with knee Osteoarthritis
Trial Acronym
not applicable
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Zubia Veqar
Designation
Honorary Director
Affiliation
Jamia Millia Islamia
Address
Centre For Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, Maulana Md Ali Jauhar Marg, Okhla, New Delhi-110025
South DELHI 110025 India
Phone
9958993486
Fax
Email
veqar.zubia@gmail.com
Details of Contact Person Scientific Query
Name
Dr Zubia Veqar
Designation
Honorary Director
Affiliation
Jamia Millia Islamia
Address
Centre For Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, Maulana Md Ali Jauhar Marg, Okhla, New Delhi-110025
South DELHI 110025 India
Phone
9958993486
Fax
Email
veqar.zubia@gmail.com
Details of Contact Person Public Query
Name
Mehnoor Khatoon
Designation
MPT Student
Affiliation
Jamia Millia Islamia
Address
Centre For Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, Maulana Md Ali Jauhar Marg, Okhla, NEW DELHI-110025
South DELHI 110025 India
Phone
7053152861
Fax
Email
mehnoorkhatoon407@gmail.com
Source of Monetary or Material Support
Jamia Millia Islamia, Mohammed Ali Jauhar Marg, Jamia Nagar, New Delhi- 110025
Primary Sponsor
Name
Jamia Millia Islamia
Address
Maulana Mohammad Ali Jauhar Marg Jamia Nagar Okhla New Delhi - 110025
Type of Sponsor
Other [(Central university)]
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 1
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Zubia Veqar
Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, Delhi NCR
Room no 202, Centre For Physiotherapy and Rehabilitation Sciences,Jamia Millia Islamia, Maulana Md Ali Jauhar Marg, Okhla, NEW DELHI, DELHI-110025
South DELHI
Conventional physiotherapy treatment for patients with OA Knee
Following the baseline measurement and assessment of outcome measures, Group A (Comparator group) will receive conventional treatment including Interferential current therapy for 20 min and supervised active exercise for 3 days/ week over 6 weeks along with home program. Active Exercises including straight leg raising, isometric quadriceps, isometric hip adduction, terminal knee extension, semi-squat, and isotonic quadriceps exercise will be given in sets of 10 repetitions, 1 set of all exercise for 1st weeks and progressed to 2 sets in the next two week and 3 sets in last three week. The patient will be educated some active exercises and stretchings and will be asked to perform them at home twice daily for 6 weeks. Handouts will also be provided for home exercises
Intervention
Retro walking along with conventional physiotherapy treatment for patients with OA knee
Participants in group B(experimental group ) will receive conventional treatment along with retro walking on treadmill. Rate of perceived exertion will be measured at baseline and Borg scale will be used. (Kevin et al., 1999). The patients will be asked to abstain from food, coffee, and cigarettes for at least 3 hours before exercise testing. After exercise testing for physical fitness Patients will be instructed to perform Retro walking on a treadmill for 15 min at their maximum pace along with conventional treatment as mentioned above for 3 days / week for 6 consecutive weeks with 5 minutes of warm up and cool down. This training program will be carried out for 3 days/week for 6 weeks with a total of 18 sessions.
Inclusion Criteria
Age From
40.00 Year(s)
Age To
70.00 Year(s)
Gender
Both
Details
a) Individuals fulfilling, clinical criteria listed by the American College of Rheumatology: knee pain and any three out of the following six criteria (age >50 years; morning stiffness lasting <30 min; crepitus on active motion; bony tenderness; bony enlargement; and no warmth on touch (Wu CW, et al. 2005).
b)Individuals on Grade 2 and 3 or mild to moderate as per Kellgren and Lawrence scale.
c)Individuals with knee pain for more than 6 weeks.
d)Age: above 40 (male and female).
e)Patient with body mass index less than 25 kg/m2
f)In case of bilateral involvement more severely involve knee will be considered.
g)Patients with pain less than 7 or equal to 3 or more on the Numerical Pain Rating Scale
ExclusionCriteria
Details
Individuals will be excluded from the study if they will have.
a)Any underlying pathology, History of ankle disease, Congenital deformities, other systemic arthritis, recent surgeries, trauma, or fractures of the lower limb
b)Known cases of severe osteoporosis.
c)With any neurological disorder including balance issues and motor and sensory loss.
d)Taking intraarticular injection for knee pain for the last 6 months
e)Presence of acute joint effusion
f)Individuals having visual dysfunction or refractory errors are not corrected with glasses or contact lenses.
g)Individuals having baseline history of established coronary artery disease (CAD), typical angina or heart failure.
h)Patient with metal implant or cardiac pacemaker.
i)Patients with uncontrolled arterial hypertension, atrial fibrillation or flutter, hypertrophic and dilated cardiomyopathy, valvular heart disease, cerebrovascular disease (history of stroke, transient ischemic attacks, or carotid artery surgery), are contraindicated to the exercise test were not included in the study. (American College of Sports Medicine. ACSM’s Guidelines for Exercise Testing and Prescription (8th edition).
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
a)Pain intensity on the NPRS scale,
b)Kinematic parameters of Gait( including Stride length, Step length, Stride time, Step time, Gait velocity & Cadence) using kinovea software
c)Balance parameters ( including COP sway, COP range, Proprioception, Reaction time, & Multidimensional stability) using pedalosensa move
d)Muscle strength ( hip flexor to hip extensor strength ratio & quadriceps to hamstring strength ratio ) using Lafayette dynamometer
week 0 , after 3rd week & after completion of 6th week
Secondary Outcome
Outcome
TimePoints
a)Functional disability score using KOOS scale,
b)Functional mobility using Time up & go test, & muscle c) muscle flexibility
week 0 , after 3rd week & after completion of 6th week
Target Sample Size
Total Sample Size="42" Sample Size from India="42" Final Enrollment numbers achieved (Total)= "0" Final Enrollment numbers achieved (India)="0"
Aim: The Objective of this RCT is to evaluate the effects of retro walking when used as an adjunct to Conventional treatment on pain, balance, gait, functional disability and mobility, muscle strength, and flexibility, in patients with OA knee compared to conventional treatment alone
Background and need of study: There is enough evidence demonstrating the effect of retro walking on pain and knee functional disability and mobility in patients with OA knee as it reduces the compressive
load on the knee but studies regarding its effect on gait, balance, muscle strength, and flexibility are inadequate as they involve the measurement of few parameters and use of conventional measuring tools. Considering this, the present study aims to investigate the effect of retro walking on strength, biomechanical gait, and balance parameters using more advanced tools in patients with knee OA.
Methods:An single -blinded randomized control trial on patients with OA knee (age 40 and above, both male and female) will be conducted in CPRS, Jamia Millia Islamia, New Delhi in accordance with the declaration of Helsinki, 1964. Considering a 12 % drop out 42 eligible patients will be randomly allocated to either group A(n=21) which will receive conventional treatment including IFT for 15 min, a supervised exercise program that includes straight leg raising, isometric quadriceps, isometric hip adduction, terminal knee extension, semi-squat, and isotonic quadriceps exercise and home program and group B(n=21) which will receive 15 min of retro walking on the treadmill along with conventional treatment for 3days /week for 6 weeks. Primary outcome measures include balance parameters (cop sway, cop range, reaction time, multidirectional stability, and proprioception), gait parameters (walking velocity, stride length, stride time, step width, step time and cadence), muscle strength (quadriceps to hamstring ratio, hip flexors to hip extensors ratio), pain intensity will be measured using pedalosensa move, kinovea software, Lafayette dynamometer and NPRS. Secondary outcome measures include hamstring flexibility, and knee function score using the KOOS scale and TUG score. Assessment of outcome measures includes pain intensity, muscle strength, flexibility, balance, kinematic gait parameters, functional disability, and mobility at baseline, after 3rd week, and immediately after post-intervention.
Conclusion and clinical implication: Findings will provide evidence on the effectiveness of retro walking and help to enhance its future implementation to conventional treatment. The study might lead to new scientific insights into the importance of retro walking in the rehabilitation of patients with OA knee. This study will help us to understand the correlation between retro walking and conventional treatment for knee osteoarthritis. It will explore and provide information about retro walking and to which extent it affects balance parameters, gait parameters, strength, flexibility, function and pain.Retro-walking could be a useful technique for improving balance, gait, function, strength of the quadriceps and hip extensors, hamstring flexibility and reduce pain when used as an adjunct to conventional treatment. Since retro-walking prevents overstretching of the ligaments and undue loading of the knee, it may be proved as a good training method for rehabilitation of patients with OA knee. As the prevalence of OA knee is increasing its importance to keep up to date for providing best treatment for reducing pain and improving function through evidence-based practice and this study could provide knowledge of body for the same. To benefit knee OA patients, it is crucial to provide them with adequate rehabilitation training to decrease pain and enhance their strength and balance. This study guides us through the new treatment approach for patients with OA knee. Findings from this study may be relevant for the development of treatment strategies for patient with OA knee.
Ethical approval: The study has been approved by Institutional Human Ethical Committee, Jamia Millia Islamia, India.