Protocol summary
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Study aim
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The purpose of this study was the effect of NASM exercises on ground reaction forces, muscle electrical activity and plantar pressures in people with piriformis syndrome, back pain and peroneitis.
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Design
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Using Gpower software, the minimum sample size for each group was estimated to be 14 people to obtain an effect size of 0.3 at a significance level of 0.05 and a statistical power of 0.95. 45 boys with flat feet, piriformis syndrome and back pain will be identified from students of Mohaghegh Ardabili University. People who had more than 10 mm of navicular bone prolapse in both feet were identified as people with flat feet. In order to determine the amount of sagging of the navicular bone, the height difference of the navicular bone from the ground in bare feet was calculated based on weight bearing in two positions, standing and sitting on a chair.
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Settings and conduct
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45 boys with flat feet, piriformis syndrome and back pain will be identified from students of Mohaghegh Ardabili University.
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Participants/Inclusion and exclusion criteria
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General conditions for entering the test: no history of wrist sprains in the past year, heel rotation outwards, wear on the inside of the examinee's shoes, injury or serious blows in the lower limbs, and no use of artificial limbs in the thigh, knee, and ankle, and illness were related to nerves. Exclusion criteria from the study included a history of fracture, surgery, orthopedic diseases, neuromuscular problems, and activity limitation according to the doctor's recommendation.
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Intervention groups
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National Academy of Sports Medicine exercises
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Main outcome variables
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Knowing the effect of NASM training on the biomechanics of walking and running; Knowing the effect of NASM training on the electrical activity of lower limb muscles in walking and running
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200912048696N2
Registration date:
2024-03-08, 1402/12/18
Registration timing:
registered_while_recruiting
Last update:
2025-02-23, 1403/12/05
Update count:
1
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Registration date
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2024-03-08, 1402/12/18
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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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2024-03-05, 1402/12/15
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Expected recruitment end date
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2024-05-04, 1403/02/15
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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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The effect of NASM exercises on ground reaction forces, muscle electrical activity, and plantar pressures in people with piriformis syndrome, back pain, and foot peroneitis
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Public title
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The effect of NASM exercises on ground reaction forces, muscle electrical activity, and plantar pressures in people with piriformis syndrome, back pain, and foot peroneitis
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
No history of wrist sprains in the past year
turning the heel outwards
wear on the inside of the subject's shoes
injuries or serious blows in the lower limbs
Not using artificial limbs in thighs, knees and ankles and diseases related to nerves
Exclusion criteria:
history of fracture
surgery
orthopedic diseases
neuromuscular problems
activity limitation according to the doctor's recommendation
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Age
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From 18 years old to 24 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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- Care provider
- Data analyser
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Sample size
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Target sample size:
45
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Randomization (investigator's opinion)
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Not randomized
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Randomization description
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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The person in charge of the laboratory will not be told which of the subjects are the control group or the experimental group, and only the principal investigator will know the complete process of the test.
Blinding will be as follows: considering that the subjects will be present in the laboratory one by one, therefore only the protocol related to him will be explained and implemented for each subject. In the meantime, the laboratory manager will not be given information about the studied groups.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2024-01-24, 1402/11/04
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Ethics committee reference number
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IR.UMA.REC.1402.051
Health conditions studied
1
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Description of health condition studied
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Piriformis syndrome
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ICD-10 code
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ICD-10 code description
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2
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Description of health condition studied
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Low back pain
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ICD-10 code
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M54.5
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ICD-10 code description
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Low back pain
3
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Description of health condition studied
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Flat foot
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ICD-10 code
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M21.4
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ICD-10 code description
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Flat foot [pes planus] (acquired)
Primary outcomes
1
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Description
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ground reaction force
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Timepoint
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8 weeks
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Method of measurement
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Force plate
2
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Description
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Electrical activities of muscles
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Timepoint
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8 weeks
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Method of measurement
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Electromyography
3
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Description
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Pressure Distribution
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Timepoint
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8 weeks
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Method of measurement
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foot scan
Intervention groups
1
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Description
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First intervention group: American National Academy of Sports Medicine exercises. The protocol of this exercise includes 4 stages of restraint, stretching, activation and cohesion techniques. The application of inhibition techniques is to affect the automatic nervous system and reduce the effects of trigger points. In the next step, lengthening or stretching techniques are used to increase the range of motion of the tissue or joint, and activation techniques are used to strengthen weak muscles.
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Category
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Rehabilitation
2
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Description
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Control group: Healthy. There will be no intervention in this group. The healthy group will only participate in the pre-test and post-test.
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Category
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Other
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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Mohaghegh Ardabili 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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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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There is no further information
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available