UMIN-CTR Clinical Trial

Basic information
Public title	Effect of Retro Walking versus Balance Training on pain and disability in patients with Osteoarthritis of Knee: A Randomized Controlled Trial.
Acronym	Rehabilitation of Osteoarthritis Knee: Retro walking Versus Balance Training
Scientific Title	Effect of Retro Walking versus Balance Training on pain and disability in patients with Osteoarthritis of Knee: A Randomized Controlled Trial.
Scientific Title:Acronym	Rehabilitation of Osteoarthritis Knee: Retro walking Versus Balance Training
Region	Asia(except Japan)

Condition
Condition	Osteoarthritis of Knee
Classification by specialty	Medicine in general Orthopedics Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To determine an efficient treatment protocol for rehabilitation of Osteoarthritis Knee patients with respect to pain and functional disability
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Intermittent and constant osteoarthritis pain measure (ICOAP) and Ibadan knee/hip osteoarthritis measure (IKHOAM).
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Conventional therapy which included exercises. The exercises were supervised by a trained physiotherapist 3 days per week for 6 weeks.Each exercise was performed for a single set of 10 repetitions twice a day for first week, and then progressed to 2 sets up to 3 weeks and finally to 3 sets up to 6 weeks.
Interventions/Control_2	Conventional therapy and retro walking training. The exercises were supervised by a trained physiotherapist 3 days per week for 6 weeks.Retro walking was done for 10 minutes on a flat surface for a distance of 30 metres at a comfortable speed
Interventions/Control_3	Conventional therapy and balance training. The exercises were supervised by a trained physiotherapist 3 days per week for 6 weeks.The exercises consisted of standing in wide base of support progressed to standing with narrow base of support, perturbations and reach outs and tandem stance. Each of these exercises was first carried out with eyes open and then eyes closed. Static postures were maintained for 30 seconds, 1 set initially then progressed to 3 sets by the 6th week.
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	45 years-old <=
Age-upper limit	60 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients with unilateral, clinically diagnosed Osteoarthritis knee reporting to the outpatient physiotherapy department.
Key exclusion criteria	Patients with severe pain >7 on Numerical pain rating scale, Body Mass Index greater than 25 kg/m2, history of lower limb trauma or surgery in the last 6 months, congenital deformities, other systemic arthritis and also patients with difficulty in walking for 10 minutes continuously.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Vijaya Middle name Last name Krishnan
Organization	MGM College of Physiotherapy
Division name	Navi Mumbai
Zip code	400705
Address	Sanpada, Navi Mumbai
TEL	9920029213
Email	victoryv2@yahoo.co.in

Public contact
Name of contact person	1st name Vijaya Middle name Last name Krishnan
Organization	MGM College of Physiotherapy
Division name	Navi Mumbai
Zip code	400705
Address	Sanpada, Navi Mumbai
TEL	9920029213
Homepage URL
Email	victoryv2@yahoo.co.in

Sponsor
Institute	MGM College of Physiotherapy
Institute
Department

Funding Source
Organization	Nil
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	MGM College of Physiotherapy
Address	Navi Mumbai
Tel	9920029213
Email	victoryv2@yahoo.co.in

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2021 Year 06 Month 09 Day

Related information
URL releasing protocol	data available on request
Publication of results	Unpublished

Result
URL related to results and publications	-
Number of participants that the trial has enrolled	60
Results	All the 3 treatment protocols showed statistically significant improvement for both pain and functional disability at the end of the 6-week. Conventional therapy with retro walking showed statistically significant response
Results date posted	2021 Year 06 Month 09 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Osteoarthritis Knee patients were randomly allocated to three groups with 20 participants in each. mean age 56.38 years and 20 males and 40 females
Participant flow	participants gave written informed consent followed by screening with respect to inclusion/exclusion criteria and then allocated to three groups. they were recruited with intent to treat
Adverse events	no adverse reaction
Outcome measures	Intermittent and constant osteoarthritis pain measure (ICOAP) and Ibadan knee/hip osteoarthritis measure (IKHOAM).
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 06 Month 23 Day
Date of IRB	2017 Year 07 Month 21 Day
Anticipated trial start date	2017 Year 08 Month 01 Day
Last follow-up date	2018 Year 01 Month 12 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 06 Month 09 Day
Last modified on	2021 Year 06 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050817