Instability, JointNCT05957965
The Effect of Wii Fit Rehabilitation in Patients With Chronic Ankle Instability a Randomized Control Study
A study testing Wii fit and Strengthening, proprioceptive exercises. in people with Instability, Joint, run by Cairo University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Instability, Joint
- What is being tested?
- Wii fit and Strengthening, proprioceptive exercises.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2023to Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Physical Therapy Cairo University
Cairo
aya abd el hady abbas abd el hady, BSC, 0201095332663, aya.abdelhady@gmail.com
About this study
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.
Read the 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
- Conditions
- Instability, Joint
- Being tested
- Wii fit, Strengthening, proprioceptive exercises.
- Keywords
- Wii fit rehabilitation, chronic ankle instability, biodex balance system
- Medical subject headings
- Joint Instability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wii fitDevice
Also called Nintendo Wii Fit system
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.
Strengthening, proprioceptive exercises.Other
Also called conventional physical therapy training
-Strengthening exercise: Ankle Dorsiflexion and Plantar Flexion \& inversion and eversion Strengthening with Exercise Bands
-Proprioceptive exercise using wobble board
| Study group | Role | What they receive |
|---|---|---|
| Conventional exercise training group | Active comparator | 30 patients will receive conventional physical therapy training only which consist of strengthening, proprioceptive exercises. Receives: Other: Strengthening, proprioceptive exercises. |
| Wii Fit rehabilitation training group | Experimental | 30 patients Wii Fit group will receive Wii Fit rehabilitation training and the same conventional exercise training (strengthening, proprioceptive exercises) Receives: Device: Wii fit; Other: Strengthening, proprioceptive exercises. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance
will be assessed by Biodex balance system (overall, Anterior posterior and mediolateral balance indices with opened eyes and closed eyes).
Measured: "up to 8 weeks"
Secondary outcomes (1)
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
Measured: "up to 8 weeks"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2023
- Study start1 Aug 2023
- Primary completionNov 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Instability, JointStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya abd el hady abbas, Cairo University
- Investigators
- maher Ahmed el kablawy, Professor, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05957965
- Sponsor's protocol ID
- clinical trial
- Status last verified
- Jan 2024
- First submitted
- 8 Jul 2023
- Last updated
- 23 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Publications
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.
PubMed 28735202Kim 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.
PubMed 26644652Kim 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.
PubMed 26696703Halaweh 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.
PubMed 26698595Franco 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.
PubMed 22508022Afridi 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.
PubMed 29540893Afridi A, Rathore FA, Nazir SNB. Wii Fit for Balance Training in Elderly: A Systematic Review. J Coll Physicians Surg Pak. 2021 May;31(5):559-566. doi: 10.29271/jcpsp.2021.05.559.
PubMed 34027869Alghadir 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.
PubMed 32718066Clark 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.
PubMed 29304510Elsotohy 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.
PubMed 33041018Gribble 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.
PubMed 27259753Pourkazemi 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.
PubMed 29325691Seyedi 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.
PubMed 34828475Shashidharan, 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).
Abdel-Aal NM, El-Kablawy MA, Kadah MA, Abbas AAEH, Basha MA, Kamel FH. Effect of Wii Fit Rehabilitation on Balance, Functional Ability, and Risk of Falling in Patients With Chronic Ankle Instability: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2026 Feb 1;105(2):110-118. doi: 10.1097/PHM.0000000000002828. Epub 2025 Aug 13.
PubMed 40857124
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Wii Fit Rehabilitation in Patients With Chronic Ankle Instability a Randomized Control Study
- ClinicalTrials.gov ID
- NCT05957965
- Acronym / sponsor ID
- clinical trial
- Conditions
- Instability, Joint
- Keywords
- Wii fit rehabilitation, chronic ankle instability, biodex balance system
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 24 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional exercise training group | Active comparator | Other: Strengthening, proprioceptive exercises.30 patients will receive conventional physical therapy training only which consist of strengthening, proprioceptive exercises. |
| Wii Fit rehabilitation training group | Experimental | Device: Wii fit, Other: Strengthening, proprioceptive exercises.30 patients Wii Fit group will receive Wii Fit rehabilitation training and the same conventional exercise training (strengthening, proprioceptive exercises) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wii fitAlso: Nintendo Wii Fit systemNintendo 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. | Device | Wii Fit rehabilitation training group |
| Strengthening, proprioceptive exercises.Also: conventional physical therapy training-Strengthening exercise: Ankle Dorsiflexion and Plantar Flexion \& inversion and eversion Strengthening with Exercise Bands -Proprioceptive exercise using wobble board | Other | Conventional exercise training group, Wii Fit rehabilitation training group |
Primary outcome
Balance
Time frame: "up to 8 weeks"
will be assessed by Biodex balance system (overall, Anterior posterior and mediolateral balance indices with opened eyes and closed eyes).
1 secondary outcome
Functional limitation
Time frame: "up to 8 weeks"
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
- Background: PubMed 28735202Punt 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.
- Background: PubMed 26644652Kim 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.
- Background: PubMed 26696703Kim 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.
- Background: PubMed 26698595Halaweh 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.
- Background: PubMed 22508022Franco 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.
- Background: PubMed 29540893Afridi 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.
- Background: PubMed 34027869Afridi A, Rathore FA, Nazir SNB. Wii Fit for Balance Training in Elderly: A Systematic Review. J Coll Physicians Surg Pak. 2021 May;31(5):559-566. doi: 10.29271/jcpsp.2021.05.559.
- Background: PubMed 32718066Alghadir 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.
- Background: PubMed 29304510Clark 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.
- Background: PubMed 33041018Elsotohy 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.
- Background: PubMed 27259753Gribble 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.
- Background: PubMed 29325691Pourkazemi 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.
- Individual participant dataSharing planned: No. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
maher Ahmed el kablawy, Professor principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wii fit and Strengthening, proprioceptive exercises. in people with Instability, Joint, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact aya abd el hady abbas abd el hady, Bsc (0201095332663, aya.abdelhady@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance (time frame: "up to 8 weeks"). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05957965, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2024.