NCT04592900

Brief Summary

Ankle sprains are common injuries in active young people. Most of these injuries recovery quickly on their own, do not require imaging, and do better with early motion and rehabilitation. High ankle sprains and fractures are much less common but more serious. They may require imaging and more treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

August 1, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

October 6, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 19, 2020

Completed
Last Updated

March 9, 2021

Status Verified

March 1, 2021

Enrollment Period

2 years

First QC Date

October 6, 2020

Last Update Submit

March 5, 2021

Conditions

Keywords

BalanceTraining,Virtual Reality,Ankle Instability.

Outcome Measures

Primary Outcomes (6)

  • dynamic balance test

    antro-posterior stability index

    antro-posterior stability index at day 0

  • dynamic balance test

    antro-posterior stability index

    antro-posterior stability index at day 90

  • dynamic balance test

    medio-lateral stability index

    medio-lateral stability index at day 0

  • dynamic balance test

    medio-lateral stability index

    medio-lateral stability index at day 90

  • dynamic balance test

    overall stability index

    overall stability index at day 0

  • dynamic balance test

    overall stability index

    overall stability index at day 90

Study Arms (3)

the control group

EXPERIMENTAL

the control group Group 1 the control group received selected physical therapy program which contain strengthening exercises for upper limb and lower limb muscles, stretching exercises for elbow extensors, hand supinator, wrist extensors, knee extensors and ankle dorsiflexors, balancing exercises, coordination exercises and balance training exercises and gait training in open environment.

Other: balance exercising

the virtual reality group

EXPERIMENTAL

Group 2 the study group received the same physical therapy program 30 min. plus virtual reality for 30 min

Other: balance exercising

the Biodex Balance Training group

EXPERIMENTAL

Group 3 the study group received the same physical therapy program 30 min. plus virtual reality for 30 min

Other: balance exercising

Interventions

selected physical therapy program strengthening the muscles of upper and lower limbs, balancing exercise, gait training in open environment,stretching for elbow flexors and forearms pronators,lower limb hip flexors and knee extensor and ankle dorsiflexors

the Biodex Balance Training groupthe control groupthe virtual reality group

Eligibility Criteria

Age13 Years - 16 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Details90 boys were recruited and assesseted for eligability then randomly divided into 3 groups each one included 30 boy
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children will have sustained lateral ankle sprain (grade II).
  • Their age was ranging from 13-16 years
  • All children with stable medical and psychological status.
  • They will able to follow the verbal commands or instructions during testing.

You may not qualify if:

  • Children with ankle or foot deformity
  • Unstable medical and psychological status.
  • Children not able to follow the verbal commands or instructions during testing
  • Children with any disorder affecting balance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nehad Ahmed Youness

Asyut, Egypt

Location

Related Publications (5)

  • Pommering TL, Kluchurosky L, Hall SL. Ankle and foot injuries in pediatric and adult athletes. Prim Care. 2005 Mar;32(1):133-61. doi: 10.1016/j.pop.2004.11.003.

    PMID: 15831316BACKGROUND
  • Waterman BR, Owens BD, Davey S, Zacchilli MA, Belmont PJ Jr. The epidemiology of ankle sprains in the United States. J Bone Joint Surg Am. 2010 Oct 6;92(13):2279-84. doi: 10.2106/JBJS.I.01537.

    PMID: 20926721BACKGROUND
  • Hootman JM, Dick R, Agel J. Epidemiology of collegiate injuries for 15 sports: summary and recommendations for injury prevention initiatives. J Athl Train. 2007 Apr-Jun;42(2):311-9.

    PMID: 17710181BACKGROUND
  • Williams MA, Soiza RL, Jenkinson AM, Stewart A. EXercising with Computers in Later Life (EXCELL) - pilot and feasibility study of the acceptability of the Nintendo(R) WiiFit in community-dwelling fallers. BMC Res Notes. 2010 Sep 13;3:238. doi: 10.1186/1756-0500-3-238.

    PMID: 20831836BACKGROUND
  • Arifin N, Abu Osman NA, Wan Abas WA. Intrarater test-retest reliability of static and dynamic stability indexes measurement using the Biodex Stability System during unilateral stance. J Appl Biomech. 2014 Apr;30(2):300-4. doi: 10.1123/jab.2013-0130. Epub 2013 Jul 20.

    PMID: 23878204BACKGROUND

Study Officials

  • Nehad A Abo-zaid

    South Valley University, Faculty of Physical Therapy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single (Outcomes Assessor) Blinding process to participants and care providers was impossible due to the nature of intervention therapy. Data were analyzed by an impartial statistician (outcomes assessor), referring to each arm with an encoded name: Group 1 (control group) and Group 2 (virtual reality group), group 3 (Biodex Balance Training)
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: G 1 (control) received traditional physical therapy program for 60 min. G 2(study) received traditional physical therapy program for 30 min. and virtual reality for 30 min. G 3 (study) received traditional physical therapy program for 30 min. and Biodex Balance Training all groups treated for four successive months.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of physical therapy

Study Record Dates

First Submitted

October 6, 2020

First Posted

October 19, 2020

Study Start

August 1, 2018

Primary Completion

August 1, 2020

Study Completion

October 1, 2020

Last Updated

March 9, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations