Comparison of the effects of exergame and balance training on dynamic postural stability during gait initiation and transition from double-leg to single-leg stance in athletes with chronic ankle instability
Comparison of the effects of exergame and balance training on dynamic postural stability during jump landing in athletes with chronic ankle instability
Design
This research is a single-blind randomized clinical trial with a control group and a sample size of 26 individuals. Participants will be randomly assigned to two groups using the randomization.com website and a block randomization method.
Settings and conduct
After receiving the ethical code, banners will be posted in three private sports physiotherapy clinics. Volunteers who express interest in participating in the program will declare informed consent by signing a written consent form approved by the Tehran University of Medical Sciences Ethics Committee. Participants will be randomly assigned to two groups: intervention and control. The treatments will be conducted over 12 sessions (4 weeks, with 3 sessions per week).Overall, assessments will be performed before and after the completion of the treatment in this study. Additionally, the analyst will be blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: The age range of 18-40 years; Both genders; Amateur athletes; History of a unilateral ankle sprain; Scoring 24 or lower on the Cumberland Ankle Instability Tool. Exclusion criteria: History of any fractures or surgeries in the lower extremity
Intervention groups
Balance exercises group: performing a series of leveled exercises. Exergame group: Performing a series of specified video games
Main outcome variables
Anterior-Posterior/Medial-Lateral and Resultant center of pressure displacement during double-leg stance, intermediate, the first 3 seconds after time to new stability point, and single-leg stance phases; Time to new stability point and anticipatory postural adjustment; Contralateral push-off duration; Contralateral push-off center of pressure excursion and displacement
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230124057209N2
Registration date:2024-06-29, 1403/04/09
Registration timing:registered_while_recruiting
Last update:2024-06-29, 1403/04/09
Update count:0
Registration date
2024-06-29, 1403/04/09
Registrant information
Name
Sadaf Sepasgozar Sarkhosh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 911 829 5466
Email address
sadaf.sepasgozar@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-26, 1403/04/06
Expected recruitment end date
2024-11-20, 1403/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of exergame and balance training on dynamic postural stability during gait initiation and transition from double-leg to single-leg stance in athletes with chronic ankle instability
Public title
Comparison of the effects of exergame and balance training on dynamic postural stability
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age range of 18-40 years
Both genders
Amateur athletes (volleyball player, basketball player, or football player) engaging in moderate to vigorous physical activity (at least 3 times per week, each session lasting more than 30 minutes
History of unilateral ankle sprain, at least 12 months prior to study entry (no more than 3 months since the last sprain at the time of study entry)
Experience of recurrent episodes of ankle giving way or feelings of instability and having symptoms such as weakness, and decreased performance over the past year
Scoring 24 or lower on the Cumberland Ankle Instability Tool
Exclusion criteria:
history of surgery or fractures in the ankle or lower extremity based on the patient's self-report
No history of training with video games
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
26
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization of individuals will be done through the randomization.com website using a block randomization method with a block size of 4. After the initial assessment, people are randomly placed in one of the two groups according to the order of their entry into the study. Additionally, to ensure blinding, opaque sealed and numbered envelopes are used, which will be provided to participants by the secretary who is not aware of the study
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants are not blind, and due to the study's design, therapist blinding is not possible. The assessor is blinded, so the assessor is different from the therapist.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
School of Nursing and Midwifery and School of Rehabilitation - Tehran University of Medical Sciences
Street address
Research and Technology Affairs Department, Room 605, 6th Floor, Tehran University of Medical Sciences Headquarters Building, Intersection of Keshavarz Boulevard and Ghods Street
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2023-01-21, 1401/11/01
Ethics committee reference number
IR.TUMS.FNM.REC.1401.146
Health conditions studied
1
Description of health condition studied
Chronic Ankle Instability
ICD-10 code
S93.4
ICD-10 code description
Sprain of ankle
Primary outcomes
1
Description
Time during anticipatory postural adjustment
Timepoint
Before starting the intervention and 48 h after the last session
Method of measurement
Force Plate device(BertecCorporation,Columbus, OH, USA)
2
Description
Time to new stability point
Timepoint
Before starting the intervention and 48 h after the last session
Method of measurement
Force Plate device(BertecCorporation,Columbus, OH, USA)
3
Description
Anterior-Posterior/Medial-Lateral and Resultant center of pressure displacement during double-leg stance phase
Timepoint
Before starting the intervention and 48 h after the last session
Method of measurement
Force Plate device(BertecCorporation,Columbus, OH, USA)
4
Description
Anterior-Posterior/Medial-Lateral and Resultant center of pressure velocity during double-leg stance phase
Timepoint
Before starting the intervention and 48 h after the last session
Method of measurement
Force Plate device(BertecCorporation,Columbus, OH, USA)
5
Description
Anterior-Posterior/Medial-Lateral and Resultant center of pressure displacement during intermediate phase
Timepoint
Before starting the intervention and 48 h after the last session
Method of measurement
Force Plate device(BertecCorporation,Columbus, OH, USA)
6
Description
Anterior-Posterior/Medial-Lateral and Resultant center of pressure velocity during intermediate phase
Timepoint
Before starting the intervention and 48 h after the last session
Method of measurement
Force Plate device(BertecCorporation,Columbus, OH, USA)
7
Description
Anterior-Posterior/Medial-Lateral and Resultant center of pressure displacement during the first 3 seconds after time to new stability point phase
Timepoint
Before starting the intervention and 48 h after the last session
Method of measurement
Force Plate device(BertecCorporation,Columbus, OH, USA)
8
Description
Anterior-Posterior/Medial-Lateral and Resultant center of pressure velocity during the first 3 seconds after time to new stability point
Timepoint
Before starting the intervention and 48 h after the last session
Method of measurement
Force Plate device(BertecCorporation,Columbus, OH, USA)
9
Description
Anterior-Posterior/Medial-Lateral and Resultant center of pressure displacement during single-leg stance phase
Timepoint
Before starting the intervention and 48 h after the last session
Method of measurement
Force Plate device(BertecCorporation,Columbus, OH, USA)
10
Description
Anterior-Posterior/Medial-Lateral and Resultant center of pressure velocity during single-leg stance phase
Timepoint
Before starting the intervention and 48 h after the last session
Method of measurement
Force Plate device(BertecCorporation,Columbus, OH, USA)
11
Description
Contralateral push-off duration
Timepoint
Before starting the intervention and 48 h after the last session
Method of measurement
Force Plate device(BertecCorporation,Columbus, OH, USA)
12
Description
Contralateral push-off center of pressure excursion
Timepoint
Before starting the intervention and 48 h after the last session
Method of measurement
Force Plate device(BertecCorporation,Columbus, OH, USA)
13
Description
Contralateral push-off center of pressure displacement
Timepoint
Before starting the intervention and 48 h after the last session
Method of measurement
Force Plate device(BertecCorporation,Columbus, OH, USA)
14
Description
Anterior-Posterior/Medial-Lateral center of pressure displacement during the anticipatory phase
Timepoint
Before starting the intervention and 48 h after the last session
Method of measurement
Force Plate device(BertecCorporation,Columbus, OH, USA)
15
Description
Anterior-Posterior/Medial-Lateral center of pressure velocity during anticipatory phase
Timepoint
Before starting the intervention and 48 h after the last session
Method of measurement
Force Plate device(BertecCorporation,Columbus, OH, USA)
16
Description
Anterior-Posterior/Medial-Lateral center of pressure displacement during the weight transition phase
Timepoint
Before starting the intervention and 48 h after the last session
Method of measurement
Force Plate device(BertecCorporation,Columbus, OH, USA)
17
Description
Anterior-Posterior/Medial-Lateral center of pressure velocity during the weight transition phase
Timepoint
Before starting the intervention and 48 h after the last session
Method of measurement
Force Plate device(BertecCorporation,Columbus, OH, USA)
18
Description
Anterior-Posterior/Medial-Lateral center of pressure displacement during the locomotor phase
Timepoint
Before starting the intervention and 48 h after the last session
Method of measurement
Force Plate device(BertecCorporation,Columbus, OH, USA)
19
Description
Anterior-Posterior/Medial-Lateral center of pressure velocity during the locomotor phase
Timepoint
Before starting the intervention and 48 h after the last session
Method of measurement
Force Plate device(BertecCorporation,Columbus, OH, USA)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The participant stays on the balance board of the Nintendo Device(Nintendo Co.Ltd., Kyoto, Japan) and plays 12 games each game has three difficulty levels (beginner, advanced, and expert), each level having four sub-levels (unstable, amateur, professional, and champion). The participant's level is determined based on the number of stars: 1 star (unstable), 2 stars (amateur), 3 stars (professional), and 4 stars (champion). If a participant is capable of playing a game at a certain level, they advance to the next level. The selection order of games in each session is based on the participants' preferences
Category
Treatment - Devices
2
Description
Control group: In this group, participants will perform a series of routine exercises over 12 sessions, with each session lasting one hour and conducted three times a week. The exercises include stretching of the gastrocnemius and soleus muscles, dorsiflexion and plantar flexion resistance exercises with a resistance band, neuromuscular exercises such as standing on one foot with eyes open and closed, ball throwing and shooting, and progressive balance exercises such as single-leg hops and jumps with a target on one foot. The exercises have varying levels of difficulty and progress over time.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr.Forough Rehabilitation Clinic
Full name of responsible person
Sadaf.Sepasgozar
Street address
Western Beginning of Baqer Khan, Chamran Highway
City
Tehran
Province
Tehran
Postal code
1964635611
Phone
+98 21 6657 2220
Email
sadaf.sepasgozar@gmail.com
2
Recruitment center
Name of recruitment center
Esteghlal Clinic
Full name of responsible person
Sadaf.Sepasgozar
Street address
Zarvan St, 14th Ave, Ansari Ave
City
تهران
Province
Tehran
Postal code
2122864670
Phone
+98 21 2286 3315
Email
sadaf.sepasgozar@gmail.com
3
Recruitment center
Name of recruitment center
Faculty of Rehabilitation, Tehran University of Medical Sciences
Full name of responsible person
Dr.Akbar.Fotoohi
Street address
Faculty of Rehabilitation, Corner of Safi Alisha Street, Pich Shemiran, Enghelab square
City
Tehran
Province
Tehran
Postal code
6511111489
Phone
+98 21 7753 3939
Email
rehabilitation@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Ali.Akbari.Sari
Street address
6th Floor, Vice-Chancellor for Research and Technology, Tehran University of Medical Sciences, Corner of Qods Street, Keshavarz Boulevard, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3685
Email
sadaf.sepasgozar@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
30
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sadaf Sepasgozar Sarkhosh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Tehran university's medical dormitory,North kargar Ave,AmirAbad
City
تهران
Province
Tehran
Postal code
1439955975
Phone
+98 911 829 5466
Email
sadaf.sepasgozar@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Roya Khanmohammadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Faculty of Rehabilitation, Corner of Safi Ali Shah Street, Pirch Shemiran, Enqelab Street, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
6511111489
Phone
+98 21 7753 4133
Email
Rkhanmohammadi@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sadaf Sepasgozar Sarkhosh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Tehran university's medical dormitory,North kargar Ave,AmirAbad
City
Tehran
Province
Tehran
Postal code
1439955975
Phone
+98 911 829 5466
Fax
Email
Sadaf.sepasgozar@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available