Protocol summary
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Study aim
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The aim of this study is to investigate the effect of instrument-assisted soft tissue mobilization on the gait biomechanics of different preferential and high walking speeds and sit to stand task as well as performance and quality of life in people with knee osteoarthritis
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Design
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Clinical trial with control group, double-blind, randomized by block design, on 34 patients
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Settings and conduct
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The location of this intervention will be in the research therapeutic center of movement disorders, Department of physiotherapy, Tarbiat Modares University. After an introductory session, people will enter the intervention phase. Individuals will be randomly assigned to the treatment and placebo groups. Participants and outcome assessors are unaware of the allocation of study groups. The intervention will be performed in four sessions over two weeks
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Women and men with knee osteoarthritis, a positive Clark test, and two and three degrees of osteoarthritis, according to the kellgren Lawrence scale؛ Exclusion criteria: Having a history of hip or knee joint fracture or ligament injury on the affected side that resulted in permanent injury
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Intervention groups
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The intervention group will be treated with instrument-assisted soft tissue mobilization along with stretching and strengthening exercises, and the control group will receive the instrument as a placebo. The intervention will be performed for both groups in four sessions over two weeks
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Main outcome variables
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Kinetic and kinematic variables of gait and sit to stand task; pain; strength; Function; Range of motion
General information
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Reason for update
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Adding review of another functional activity
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20201128049511N2
Registration date:
2021-12-25, 1400/10/04
Registration timing:
prospective
Last update:
2023-01-09, 1401/10/19
Update count:
1
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Registration date
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2021-12-25, 1400/10/04
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2022-01-05, 1400/10/15
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Expected recruitment end date
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2022-08-21, 1401/05/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Effect of Instrument-Assisted Soft Tissue Mobilization on Gait and Sit to Stand Task Biomechanics in Individuals with Knee Osteoarthritis
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Public title
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Effects of Instrument-Assisted Soft Tissue Release on Walking and Sit to Stand in Individuals with Knee Osteoarthritis
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
Women and men with osteoarthritis of the knee
Ability to walk without the use of assistive devices
Pain between three and six in one knee, according to the visual analogue scale
A positive clark test result
Grade two and three osteoarthritis, according to the Kellgren-Lawrence scale
Exclusion criteria:
Have a history of a hip or knee joint fracture or ligament injury on the affected side that has resulted in permanent injury
Candidate for knee replacement surgery
Any congenital disease of the lower extremities or lower back or any orthopedic, neurological, or rheumatic disease that interferes with a person's normal gait or sit to stand task
Joint injection in the last six months
The difference in the length of the lower limbs is more than one and a half centimeters
Medium to high intensity involvement of both knees
Genovarum with a knee angle greater than 10 degrees
A body mass index greater than 30
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Age
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From 45 years old to 80 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Outcome assessor
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Sample size
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Target sample size:
34
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Participants will be randomly divided into two groups: treatment and placebo. In this way, four blocks are identified, of which two blocks belong to the placebo group and two blocks belong to the treatment group.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Participants are unaware of the allocation of study groups. The treatment in the two groups is quite similar, and the only difference in the use of tools in the placebo group is that they are exactly the same instruments used in the treatment group, but the intensity of pressure and the type of movement of the tool are different. The intensity of pressure and type of movement are two subjects that patients do not have and will not notice if they are in the placebo or treatment group. The outcome assessor is also unaware of the grouping of individuals.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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People are randomly divided into two groups. The intervention group receives the instrument along with exercise therapy. The control group will receive the instrument as a placebo along with exercise therapy
Ethics committees
1
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Ethics committee
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Approval date
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2021-10-23, 1400/08/01
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Ethics committee reference number
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IR.MODARES.REC.1400.202
Health conditions studied
1
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Description of health condition studied
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Knee Osteoarthritis
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ICD-10 code
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M17
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ICD-10 code description
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Osteoarthritis of knee
Primary outcomes
1
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Description
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Gait and sit to stand task kinematic and kinetic variables
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Timepoint
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Before and after the Intervention
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Method of measurement
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Inverse dynamics and force plate
2
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Description
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Pain
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Timepoint
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Before and after the Intervention
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Method of measurement
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Visual analogue scale
3
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Description
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Strength
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Timepoint
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Before and after the Intervention
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Method of measurement
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Dynamometer
4
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Description
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Musculoskelatal performance
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Timepoint
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Before and after the Intervention
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Method of measurement
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Functional tests
5
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Description
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Range of motion
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Timepoint
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Before and after the Intervention
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Method of measurement
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Goniameter
Secondary outcomes
1
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Description
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Quality of life
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Timepoint
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Before and after the Intervention
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Method of measurement
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Questionnaire
Intervention groups
1
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Description
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Intervention group: A series of lightweight steel instruments are gently applied to the muscles around the knee. The movement of the instrument in specific therapeutic directions is applied to the skin based on the initial assessment, and an emollient is used to move the instrument more easily. The treatment time with this tool is approximately five minutes. Then stretching and strengthening exercises are performed.
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Category
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Treatment - Other
2
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Description
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Control group: Steel instruments are gently applied to the muscles around the knee in this group. Using an emollient, the instrument is applied as a placebo with the least amount of pressure on the skin in all directions. The tool is moved on the patient's skin in different directions without considering the initial assessment. The direction and pressure applied by the instrument have no therapeutic properties. The treatment time is approximately five minutes. Then stretching and strengthening exercises are performed.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tarbiat Modares University
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Information about the main outcome can be shared after people are not identified
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When the data will become available and for how long
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After the results are published, the access phase started six months later
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To whom data/document is available
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Researchers in academic and research organizations will also have access to the data
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Under which criteria data/document could be used
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to do scientific research
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From where data/document is obtainable
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Sahar Boozari, Jalal Al Ahmad Highway, Tarbiat Modares University
s.boozari@modares.ac.ir, 00982182885053
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What processes are involved for a request to access data/document
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Send the project plan, and if approved, it will be sent following a complete evaluation of the persons and organizations involved in the project
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Comments
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