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Comparing VR and Balance Exercises In Rehabilitation of Adolescent Athletes

Primary Purpose

Sport Injury

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
balance exercising
Sponsored by
South Valley University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sport Injury focused on measuring BalanceTraining,, Virtual Reality,, Ankle Instability.

Eligibility Criteria

13 Years - 16 Years (Child)MaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Nehad Ahmed Youness

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

the control group

the virtual reality group

the Biodex Balance Training group

Arm Description

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.

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

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

Outcomes

Primary Outcome Measures

dynamic balance test
antro-posterior stability index
dynamic balance test
antro-posterior stability index
dynamic balance test
medio-lateral stability index
dynamic balance test
medio-lateral stability index
dynamic balance test
overall stability index
dynamic balance test
overall stability index

Secondary Outcome Measures

Full Information

First Posted
October 6, 2020
Last Updated
March 5, 2021
Sponsor
South Valley University
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1. Study Identification

Unique Protocol Identification Number
NCT04592900
Brief Title
Comparing VR and Balance Exercises In Rehabilitation of Adolescent Athletes
Official Title
Virtual Reality Versus Biodex Balance Training In Adolescent Athletes With Chronic Ankle Instability.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
August 1, 2020 (Actual)
Study Completion Date
October 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
South Valley University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Phases of rehabilitation for ankle sprain Phase I treatment involves resting and protecting the ankle to permit healing, to prevent further injury, and to control pain and swelling. Phase II treatment begins once pain and swelling have subsided to the point where the athlete can comfortably bear weight and walk from place to place. Virtual reality (VR) is a simulated experience that can be similar to or completely different from the real world. Applications of virtual reality can include entertainment (i.e. video games) and educational purposes (i.e. medical or military training). Other, distinct types of VR style technology include augmented reality and mixed reality. Biodex Balance Training is one of the main tool that used to assess dynamic balance and dynamic limits of stability also it can used as training tool to improve the participant balance training

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sport Injury
Keywords
BalanceTraining,, Virtual Reality,, Ankle Instability.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Participant
Masking Description
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)
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
the control group
Arm Type
Experimental
Arm Description
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.
Arm Title
the virtual reality group
Arm Type
Experimental
Arm Description
Group 2 the study group received the same physical therapy program 30 min. plus virtual reality for 30 min
Arm Title
the Biodex Balance Training group
Arm Type
Experimental
Arm Description
Group 3 the study group received the same physical therapy program 30 min. plus virtual reality for 30 min
Intervention Type
Other
Intervention Name(s)
balance exercising
Intervention Description
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
Primary Outcome Measure Information:
Title
dynamic balance test
Description
antro-posterior stability index
Time Frame
antro-posterior stability index at day 0
Title
dynamic balance test
Description
antro-posterior stability index
Time Frame
antro-posterior stability index at day 90
Title
dynamic balance test
Description
medio-lateral stability index
Time Frame
medio-lateral stability index at day 0
Title
dynamic balance test
Description
medio-lateral stability index
Time Frame
medio-lateral stability index at day 90
Title
dynamic balance test
Description
overall stability index
Time Frame
overall stability index at day 0
Title
dynamic balance test
Description
overall stability index
Time Frame
overall stability index at day 90

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
90 boys were recruited and assesseted for eligability then randomly divided into 3 groups each one included 30 boy
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nehad A Abo-zaid
Organizational Affiliation
South Valley University, Faculty of Physical Therapy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nehad Ahmed Youness
City
Assiut
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
15831316
Citation
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.
Results Reference
background
PubMed Identifier
20926721
Citation
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.
Results Reference
background
PubMed Identifier
17710181
Citation
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.
Results Reference
background
PubMed Identifier
20831836
Citation
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.
Results Reference
background
PubMed Identifier
23878204
Citation
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.
Results Reference
background

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Comparing VR and Balance Exercises In Rehabilitation of Adolescent Athletes

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