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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000044483
Receipt No. R000050817
Scientific Title Effect of Retro Walking versus Balance Training on pain and disability in patients with Osteoarthritis of Knee: A Randomized Controlled Trial.
Date of disclosure of the study information 2021/06/09
Last modified on 2021/06/09

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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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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