Back to resultsThe Effect of Wii Fit Rehabilitation
Primary Purpose
Instability, Joint
Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Wii fit
Strengthening, proprioceptive exercises.
Sponsored by
About this trial
This is an interventional treatment trial for Instability, Joint focused on measuring Wii fit rehabilitation, chronic ankle instability, biodex balance system
Eligibility Criteria
Inclusion Criteria: Sixty patients, their age ranges between 18 to 60 years old. Patients of both gender (men and women) A history of at least one ankle sprain, with the initial sprain occurring more than 1-year before the study A feeling of ''giving way'' at least 2 episodes in the last 6 months before the study Experiencing a recurring sprain, which is defined as two or more sprains on the same ankle No history of ankle injury within the three months prior to participation, and no cognitive deficit Capability to perform the intervention or daily activities without an increase in pain Currently they are not participating in any other rehabilitation exercise programs No history of ankle surgery Exclusion Criteria: Subjects had balance deficits due to vestibular disorders, such as vertebro-basilar insufficiency and/or visual disorders Tumors in the area to be treated for the study pregnancy Any injury or surgery done in ankle joint, deformity at lower extremity Musculoskeletal condition like fracture, osteoporosis Neurological condition like parkinsonism disease, ataxia, stroke, muscular dystrophy, myasthenia gravis Cardiopulmonary conditions
Sites / Locations
- Faculty of Physical Therapy Cairo University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Conventional exercise training group
Wii Fit rehabilitation training group
Arm Description
30 patients will receive conventional physical therapy training only which consist of strengthening, proprioceptive exercises.
30 patients Wii Fit group will receive Wii Fit rehabilitation training and the same conventional exercise training (strengthening, proprioceptive exercises)
Outcomes
Primary Outcome Measures
Balance
will be assessed by Biodex balance system (overall, Anterior posterior and mediolateral balance indices with opened eyes and closed eyes).
Secondary Outcome Measures
Functional limitation
will be assessed by Arabic version of the Foot and Ankle Ability Measure (FAAM). The FAAM consists of a 21-item Activities of Daily Living (ADL) scale and an 8- item Sports scale
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05957965
Brief Title
The Effect of Wii Fit Rehabilitation
Official Title
The Effect of Wii Fit Rehabilitation in Patients With Chronic Ankle Instability a Randomized Control Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 2023 (Anticipated)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The goal of this clinical trial is to investigate the effect of Wii Fit rehabilitation on risk of fall, balance, and functional limitation, in patients with chronic ankle instability ,The main question it aims to answer is:
Are there any effect of Wii Fit rehabilitation training on balance, functional limitation, and risk of falls in patients with chronic ankle instability? Participants will be asked to sign a written informed consent form before the study according to guidelines of ethical committee The first group control group: 30 patients will receive conventional physical therapy training only which consist of strengthening, proprioceptive exercises.
The second group experimental group: 30 patients Wii Fit group will receive Wii Fit rehabilitation training and the same conventional exercise training.
Detailed Description
Wii Fit is an effective virtual reality approach for balance training. This intervention requires less time per session compared to traditional physical therapy treatment. Moreover, it is user-friendly, engaging, cost-effective and can be delivered at home without the need for supervision by a trained rehabilitation professional. Given the growing popularity of the technological approach as Wii Fit intervention, it would be important for the rehabilitation field to replicate these findings as high quality randomized clinical trials with large sample size and equal distribution of males and females.Further researches are needed to assess the long term effect of Wii training in patients with functional ankle instability. A variety of exercise programs were used as an intervention for chronic ankle instability, and conservative treatment interventions including balance, proprioceptive, and muscle strengthening exercises are effective for patients with chronic ankle instability
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Instability, Joint
Keywords
Wii fit rehabilitation, chronic ankle instability, biodex balance system
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Conventional exercise training group
Arm Type
Active Comparator
Arm Description
30 patients will receive conventional physical therapy training only which consist of strengthening, proprioceptive exercises.
Arm Title
Wii Fit rehabilitation training group
Arm Type
Experimental
Arm Description
30 patients Wii Fit group will receive Wii Fit rehabilitation training and the same conventional exercise training (strengthening, proprioceptive exercises)
Intervention Type
Device
Intervention Name(s)
Wii fit
Other Intervention Name(s)
Nintendo Wii Fit system
Intervention Description
Nintendo Wii console (Nintendo Co., Ltd, Kyoto, Japan) is the main power unit of Nintendo Wii Fit. Its software includes an interactive video games that is played with a handheld, wireless remote that senses motion and requires the participant to mimic the action of their on - screen character. These games are played using a special Wii balance board in order to perform activities like yoga, balance and aerobics. The Wii remote is the primary controller for Nintendo's Wii console. The motion sensing capability is the main feature of it. It allows the user to interact with and manipulate items on screen via pointing.
Intervention Type
Other
Intervention Name(s)
Strengthening, proprioceptive exercises.
Other Intervention Name(s)
conventional physical therapy training
Intervention Description
-Strengthening exercise: Ankle Dorsiflexion and Plantar Flexion & inversion and eversion Strengthening with Exercise Bands
-Proprioceptive exercise using wobble board
Primary Outcome Measure Information:
Title
Balance
Description
will be assessed by Biodex balance system (overall, Anterior posterior and mediolateral balance indices with opened eyes and closed eyes).
Time Frame
"up to 8 weeks"
Secondary Outcome Measure Information:
Title
Functional limitation
Description
will be assessed by Arabic version of the Foot and Ankle Ability Measure (FAAM). The FAAM consists of a 21-item Activities of Daily Living (ADL) scale and an 8- item Sports scale
Time Frame
"up to 8 weeks"
Other Pre-specified Outcome Measures:
Title
Risk of fall
Description
will be assessed by the Arabic Version of the Falls Efficacy Scale questionnaire
Time Frame
"up to 8 weeks"
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Sixty patients, their age ranges between 18 to 60 years old.
Patients of both gender (men and women)
A history of at least one ankle sprain, with the initial sprain occurring more than 1-year before the study
A feeling of ''giving way'' at least 2 episodes in the last 6 months before the study
Experiencing a recurring sprain, which is defined as two or more sprains on the same ankle
No history of ankle injury within the three months prior to participation, and no cognitive deficit
Capability to perform the intervention or daily activities without an increase in pain
Currently they are not participating in any other rehabilitation exercise programs
No history of ankle surgery
Exclusion Criteria:
Subjects had balance deficits due to vestibular disorders, such as vertebro-basilar insufficiency and/or visual disorders
Tumors in the area to be treated for the study
pregnancy
Any injury or surgery done in ankle joint, deformity at lower extremity
Musculoskeletal condition like fracture, osteoporosis
Neurological condition like parkinsonism disease, ataxia, stroke, muscular dystrophy, myasthenia gravis
Cardiopulmonary conditions
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
aya abd el hady abbas abd el hady, Bsc
Phone
0201095332663
Email
aya.abdelhady@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
maher Ahmed el kablawy, Professor
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Physical Therapy Cairo University
City
Cairo
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
aya abd el hady abbas abd el hady, BSC
Phone
0201095332663
Email
aya.abdelhady@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
NO individual participant data will be shared. Results will be published by the investigators in academic journal.
sharing of generated study data will be carried out in several different ways. We plan to make our results available to researchers and potential collaborators
Citations:
PubMed Identifier
28735202
Citation
Punt IM, Armand S, Ziltener JL, Allet L. Effect of Wii Fit exercise therapy on gait parameters in ankle sprain patients: A randomized controlled trial. Gait Posture. 2017 Oct;58:52-58. doi: 10.1016/j.gaitpost.2017.06.284. Epub 2017 Jun 29.
Results Reference
background
PubMed Identifier
26644652
Citation
Kim KJ, Heo M. Effects of virtual reality programs on balance in functional ankle instability. J Phys Ther Sci. 2015 Oct;27(10):3097-101. doi: 10.1589/jpts.27.3097. Epub 2015 Oct 30.
Results Reference
background
PubMed Identifier
26696703
Citation
Kim KJ, Jun HJ, Heo M. Effects of Nintendo Wii Fit Plus training on ankle strength with functional ankle instability. J Phys Ther Sci. 2015 Nov;27(11):3381-5. doi: 10.1589/jpts.27.3381. Epub 2015 Nov 30.
Results Reference
background
PubMed Identifier
26698595
Citation
Halaweh H, Svantesson U, Rosberg S, Willen C. Cross-Cultural Adaptation, Validity and Reliability of the Arabic Version of the Falls Efficacy Scale-International (FES-I). Med Princ Pract. 2016;25(1):1-7. doi: 10.1159/000441128. Epub 2015 Oct 20.
Results Reference
background
PubMed Identifier
22508022
Citation
Franco JR, Jacobs K, Inzerillo C, Kluzik J. The effect of the Nintendo Wii Fit and exercise in improving balance and quality of life in community dwelling elders. Technol Health Care. 2012;20(2):95-115. doi: 10.3233/THC-2011-0661.
Results Reference
background
PubMed Identifier
29540893
Citation
Afridi A, Malik AN, Ali S, Amjad I. Effect of balance training in older adults using Wii fit plus. J Pak Med Assoc. 2018 Mar;68(3):480-483.
Results Reference
background
PubMed Identifier
34027869
Citation
Afridi A, Rathore FA, Nazir SNB. Wii Fit for Balance Training in Elderly: A Systematic Review. J Coll Physicians Surg Pak. 2021 May;30(5):559-566. doi: 10.29271/jcpsp.2021.05.559.
Results Reference
background
PubMed Identifier
32718066
Citation
Alghadir AH, Iqbal ZA, Iqbal A, Ahmed H, Ramteke SU. Effect of Chronic Ankle Sprain on Pain, Range of Motion, Proprioception, and Balance among Athletes. Int J Environ Res Public Health. 2020 Jul 23;17(15):5318. doi: 10.3390/ijerph17155318.
Results Reference
background
PubMed Identifier
29304510
Citation
Clark RA, Mentiplay BF, Pua YH, Bower KJ. Reliability and validity of the Wii Balance Board for assessment of standing balance: A systematic review. Gait Posture. 2018 Mar;61:40-54. doi: 10.1016/j.gaitpost.2017.12.022. Epub 2017 Dec 30.
Results Reference
background
PubMed Identifier
33041018
Citation
Elsotohy NM, Salim YE, Nassif NS, Hanafy AF. Cross-education effect of balance training program in patients with chronic ankle instability: A randomized controlled trial. Injury. 2021 Mar;52(3):625-632. doi: 10.1016/j.injury.2020.09.065. Epub 2020 Oct 1.
Results Reference
background
PubMed Identifier
27259753
Citation
Gribble PA, Bleakley CM, Caulfield BM, Docherty CL, Fourchet F, Fong DT, Hertel J, Hiller CE, Kaminski TW, McKeon PO, Refshauge KM, Verhagen EA, Vicenzino BT, Wikstrom EA, Delahunt E. Evidence review for the 2016 International Ankle Consortium consensus statement on the prevalence, impact and long-term consequences of lateral ankle sprains. Br J Sports Med. 2016 Dec;50(24):1496-1505. doi: 10.1136/bjsports-2016-096189. Epub 2016 Jun 3.
Results Reference
background
PubMed Identifier
29325691
Citation
Pourkazemi F, Hiller CE, Raymond J, Black D, Nightingale EJ, Refshauge KM. Predictors of recurrent sprains after an index lateral ankle sprain: a longitudinal study. Physiotherapy. 2018 Dec;104(4):430-437. doi: 10.1016/j.physio.2017.10.004. Epub 2017 Nov 2.
Results Reference
background
PubMed Identifier
34828475
Citation
Seyedi M, Nobari H, Abbasi H, Khezri D, Oliveira R, Perez-Gomez J, Badicu G, Afonso J. Effect of Four Weeks of Home-Based Balance Training on the Performance in Individuals with Functional Ankle Instability: A Remote Online Study. Healthcare (Basel). 2021 Oct 23;9(11):1428. doi: 10.3390/healthcare9111428.
Results Reference
background
Citation
Shashidharan, Srisha & Selvan, Vijay. Effects of Virtual Reality Based Training (VRBT) and Proprioceptive Training for Improving Dynamic Balance in Chronic Ankle Instability (CAI) Patients -A Comparative Study (2022).
Results Reference
background
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The Effect of Wii Fit Rehabilitation
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