NCT05957965

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 24, 2023

Completed
8 days until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

January 23, 2024

Status Verified

January 1, 2024

Enrollment Period

1.3 years

First QC Date

July 8, 2023

Last Update Submit

January 22, 2024

Conditions

Keywords

Wii fit rehabilitationchronic ankle instabilitybiodex balance system

Outcome Measures

Primary Outcomes (1)

  • Balance

    will be assessed by Biodex balance system (overall, Anterior posterior and mediolateral balance indices with opened eyes and closed eyes).

    "up to 8 weeks"

Secondary Outcomes (1)

  • Functional limitation

    "up to 8 weeks"

Other Outcomes (1)

  • Risk of fall

    "up to 8 weeks"

Study Arms (2)

Conventional exercise training group

ACTIVE COMPARATOR

30 patients will receive conventional physical therapy training only which consist of strengthening, proprioceptive exercises.

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)

Device: Wii fitOther: Strengthening, proprioceptive exercises.

Interventions

Wii fitDEVICE

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.

Also known as: Nintendo Wii Fit system
Wii Fit rehabilitation training group

-Strengthening exercise: Ankle Dorsiflexion and Plantar Flexion \& inversion and eversion Strengthening with Exercise Bands -Proprioceptive exercise using wobble board

Also known as: conventional physical therapy training
Conventional exercise training groupWii Fit rehabilitation training group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy Cairo University

Cairo, Egypt

RECRUITING

Related Publications (15)

  • 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.

    PMID: 28735202BACKGROUND
  • 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.

    PMID: 26644652BACKGROUND
  • 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.

    PMID: 26696703BACKGROUND
  • 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.

    PMID: 26698595BACKGROUND
  • 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.

    PMID: 22508022BACKGROUND
  • 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.

    PMID: 29540893BACKGROUND
  • Afridi 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.

    PMID: 34027869BACKGROUND
  • 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.

    PMID: 32718066BACKGROUND
  • 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.

    PMID: 29304510BACKGROUND
  • 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.

    PMID: 33041018BACKGROUND
  • 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.

    PMID: 27259753BACKGROUND
  • 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.

    PMID: 29325691BACKGROUND
  • 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.

    PMID: 34828475BACKGROUND
  • 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).

    BACKGROUND
  • 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.

MeSH Terms

Conditions

Joint Instability

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • maher Ahmed el kablawy, Professor

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

aya abd el hady abbas abd el hady, Bsc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator aya abd el hady abbas

Study Record Dates

First Submitted

July 8, 2023

First Posted

July 24, 2023

Study Start

August 1, 2023

Primary Completion

November 1, 2024

Study Completion

November 1, 2024

Last Updated

January 23, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

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

Locations