Protocol summary
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Study aim
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Determining the effect of neuromuscular training with and without cognitive intervention on balance, strength, proprioception and center of pressure displacement in active females at risk of ankle sprain
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Design
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The clinical trial has two groups of neuromuscular training with cognitive intervention and neuromuscular without cognitive intervention, with parallel groups, double-blinded, randomized, phase 2 on 44 participants. Randomization is done based on the Random Number Generator software, and they will be assigned to double groups based on the allocation concealment using the SNOSE method.
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Settings and conduct
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This study will be performed in a double-blinded manner. The tests will be taken in the sport rehabilitation laboratory of Bu Ali Sina University in Hamedan by specialists, then intervention and exersices will take place in the university gym.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria include: active females at risk of ankle sprain with a normal body mass index of 20-25, age range of 16-30 years, dynamic balance score and a score of 13-15 from the Beck questionnaire and exclusion criteria: a history of ankle sprain injury, fracture, injury or surgery of the lower limb, abnormalities of the lower limb such as: foot flat, genu varum, genu valgum, genu recurvatom, history of vestibular system disorders, the presence of diseases such as diabetes
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Intervention groups
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Group of neuromuscular training with cognitive intervention: balance, strength, plyometric and agility exercises with cognitive exercises to examine the amount of attention needs of pastural control for 8 weeks and three 1-hour sessions every week. Group of neuromuscular training without cognitive intervention: balance, strength, plyometric and agility exercises for 8 weeks and three 1-hour sessions every week.
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Main outcome variables
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Balance, Strength, Proprioception, Center of pressure displacement
General information
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Reason for update
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Editing the original English name of the device that will be used in the laboratory to measure the primary outcome variable of displacement of the center of pressure, adding items related to how to measure the secondary outcome variable of chronic ankle instability, editing the English related to the intervention groups in the protocol abstract.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20230619058535N1
Registration date:
2023-06-26, 1402/04/05
Registration timing:
prospective
Last update:
2023-06-28, 1402/04/07
Update count:
1
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Registration date
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2023-06-26, 1402/04/05
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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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2023-08-25, 1402/06/03
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Expected recruitment end date
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2023-09-04, 1402/06/13
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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 neuromuscular training with and without cognitive intervention on proprioception‚ balance‚ strength and center of pressure displacement in active females at risk of ankle sprain
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Public title
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The effect of neuromuscular training with and without cognitive intervention on ankle sprain
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
Normal body mass index is 20-25
Age range 16-30 years
Obtaining a dynamic balance score
Obtaining a score of 13-15 from Beck's questionnaire
Exclusion criteria:
History of ankle sprain injury
History of fracture, injury or surgery of the lower limb
Abnormalities of the lower limbs include Foot Flat, Genu Varum, Genu Valgum, Genu Recurvatom
History of Vestibular System disorders
The presence of diseases such as diabetes
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Age
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From 16 years old to 30 years old
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Gender
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Female
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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:
44
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization is done based on the Random Number Generator software, and they will be assigned to double groups based on the allocation concealment using the SNOSE method. The randomization of subjects is done in two steps. First, each subject chooses a number between 1-30 using a lottery, then fifteen random numbers are selected between 1-30 numbers using the Random Number Generator software and according to the generated numbers and the selected numbers, subjects are divided into two groups.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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In this study, outcome assessors (laboratory technicians) are asked to take the desired tests from the clients. These people will be unaware of the purpose of the research, the allocation of study groups and the reason for their presence in the laboratory, and they will only evaluate the variables and record their observations.
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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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2023-04-11, 1402/01/22
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Ethics committee reference number
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IR.BASU.REC.1402.022
Health conditions studied
1
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Description of health condition studied
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Ankle sprain
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ICD-10 code
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S93.4
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ICD-10 code description
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Sprain of ankle
Primary outcomes
1
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Description
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Balance
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Timepoint
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Before the intervention begins, one day after the end of the intervention
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Method of measurement
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Y balance test, Foot lift test
2
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Description
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Strength
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Timepoint
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Before the intervention begins, one day after the end of the intervention
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Method of measurement
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Dynamometer
3
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Description
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Proprioception
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Timepoint
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Before the intervention begins, one day after the end of the intervention
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Method of measurement
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Electrogoniometer
4
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Description
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Center of pressure displacement
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Timepoint
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Before the intervention begins, one day after the end of the intervention
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Method of measurement
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RS-Scan device
Secondary outcomes
1
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Description
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Chronic ankle instability (CAI)
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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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Electrogoniometer, Dynamometer, RS-Scan device, Y balance test, Foot lift test
Intervention groups
1
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Description
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The neuromuscular training with cognitive intervention, exercises for 8 weeks and three 1-hour sessions each week. Neuromuscular training will include balance, strength, plyometric and agility exercises. Cognitive exercises will be used as an effective strategy for this group to examine the amount of attention needs of pastural control.
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Category
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Prevention
2
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Description
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Intervention group: the neuromuscular training without cognitive intervention, exercises for 8 weeks and three 1-hour sessions each we ek. Neuromuscular training will include balance, strength, plyometric and agility exercises.
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Category
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Prevention
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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The University of Bu Ali Sina
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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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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available