UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044483 |
|---|---|
| Receipt number | 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 17:15:46 |
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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
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
victoryv2@yahoo.co.in
Sponsor or person
Institute
MGM College of Physiotherapy
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050817
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