- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04533789
Virtual Reality versusTask-oriented for Gait in CP
Wii Sport Games Versus Task-oriented Training on Gait in Children With Unilateral Cerebral Palsy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This research aims to evaluate the effect of virtual reality (VR) games on balance recovery of children with cerebral palsy (CP) by quantitatively synthesizing the existing literature, and to further determine the impact of VR game intervention (the duration of each intervention, intervention frequency, intervention cycle, and total intervention time) on the balance recovery of children with CP.
A high-intensity task-oriented training programme designed to improve hemiplegic gait and physical fitness was feasible in the present study and the effectiveness exceeds a low intensity physiotherapy-programme in terms of gait speed and walking capacity in hemiplegic cp. In a future study, seems appropriate to additionally use measures to evaluate physical fitness and energy expenditure while walking.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Qina,, Egypt, 83523
- South Valley University, Faculty of Physical Therapy
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Their age will ranging from 7 to 9 years.
- Children participated in this study will from both sexes.
- Their degree of spasticity will ranged from mild to moderate according to Modified Ashworth Scale.
- All children will able to walk supported or unsupported by the therapist.
- Children will able to follow the instructions during testing and training.
- All children had no fixed contractures or deformities at the lower limb.
Exclusion Criteria:
- Children with visual or auditory problems.
- Children with history of epilepsy.
- Children with structural joints deformities of the lower limbs.
- Children with history of surgical interference in lower limbs less than one year.
- Children with convulsions and fixed contractures.
- Uncooperative children.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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 gait training exercises in open environment.
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strengthening muscles of upper and lower limbs, balancing exercise, gait training in open environment, stretching for elbow flexors and forearm pronators,lower limb hip flexors and knee extensor and ankle dorsiflexors
|
|
Experimental: virtual reality
Group 2 the study group received the same physical therapy program 30 min.
plus virtual reality for 30 min.
|
strengthening muscles of upper and lower limbs, balancing exercise, gait training in open environment, stretching for elbow flexors and forearm pronators,lower limb hip flexors and knee extensor and ankle dorsiflexors
|
|
Experimental: Task oriented
Group 3 the study group received the same physical therapy program 30 min.
plus task oriented training for 30 min.
|
strengthening muscles of upper and lower limbs, balancing exercise, gait training in open environment, stretching for elbow flexors and forearm pronators,lower limb hip flexors and knee extensor and ankle dorsiflexors
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
cadence (number)
Time Frame: cadence assessed at day 0.
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number of steps in each min.
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cadence assessed at day 0.
|
|
cadence (number)
Time Frame: cadence assessed at day 90.
|
number of steps in each min.
|
cadence assessed at day 90.
|
|
step length of affected side (cm)
Time Frame: step length assessed at day 0.
|
distance between the point of initial contact of one foot and the point of initial contact of the opposite foot (cm)
|
step length assessed at day 0.
|
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step length of affected side (cm)
Time Frame: step length assessed at day 90.
|
distance between the point of initial contact of one foot and the point of initial contact of the opposite foot (cm)
|
step length assessed at day 90.
|
|
stride length of affected side(cm)
Time Frame: stride length assessed at day 0.
|
the distance from the toe of right foot (starting position) to the toe of right foot (ending position), or the heel of right foot (starting position) to the heel of right foot (ending position).
(cm)
|
stride length assessed at day 0.
|
|
stride length of affected side(cm)
Time Frame: stride length assessed at day 90.
|
the distance from the toe of right foot (starting position) to the toe of right foot (ending position), or the heel of right foot (starting position) to the heel of right foot (ending position).
(cm)
|
stride length assessed at day 90.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mohammed E Ali, PhD student, South Valley University, Faculty of Physical Therapy
Publications and helpful links
General Publications
- Patterson KK, Gage WH, Brooks D, Black SE, McIlroy WE. Evaluation of gait symmetry after stroke: a comparison of current methods and recommendations for standardization. Gait Posture. 2010 Feb;31(2):241-6. doi: 10.1016/j.gaitpost.2009.10.014. Epub 2009 Nov 22.
- Wang X, Wang Y. Gait analysis of children with spastic hemiplegic cerebral palsy. Neural Regen Res. 2012 Jul 15;7(20):1578-84. doi: 10.3969/j.issn.1673-5374.2012.20.008.
- Grasso R, Assaiante C, Prevost P, Berthoz A. Development of anticipatory orienting strategies during locomotor tasks in children. Neurosci Biobehav Rev. 1998 Jul;22(4):533-9. doi: 10.1016/s0149-7634(97)00041-9.
- Gatica-Rojas V, Mendez-Rebolledo G, Guzman-Munoz E, Soto-Poblete A, Cartes-Velasquez R, Elgueta-Cancino E, Cofre Lizama LE. Does Nintendo Wii Balance Board improve standing balance? A randomized controlled trial in children with cerebral palsy. Eur J Phys Rehabil Med. 2017 Aug;53(4):535-544. doi: 10.23736/S1973-9087.16.04447-6. Epub 2016 Nov 24.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/001729
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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