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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04533789
Other study ID # P.T.REC/012/001729
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 22, 2019
Est. completion date July 29, 2020

Study information

Verified date August 2020
Source South Valley University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The children with hemiplegic cerebral palsy had a longer gait cycle, slower walking speed, and longer support phase than did the healthy children. The support phase was longer than the swing phase in the children with hemiplegic cerebral palsy


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.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date July 29, 2020
Est. primary completion date May 22, 2020
Accepts healthy volunteers No
Gender All
Age group 7 Years to 9 Years
Eligibility Inclusion Criteria:

1. Their age will ranging from 7 to 9 years.

2. Children participated in this study will from both sexes.

3. Their degree of spasticity will ranged from mild to moderate according to Modified Ashworth Scale.

4. All children will able to walk supported or unsupported by the therapist.

5. Children will able to follow the instructions during testing and training.

6. All children had no fixed contractures or deformities at the lower limb.

Exclusion Criteria:

1. Children with visual or auditory problems.

2. Children with history of epilepsy.

3. Children with structural joints deformities of the lower limbs.

4. Children with history of surgical interference in lower limbs less than one year.

5. Children with convulsions and fixed contractures.

6. Uncooperative children.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
selected physical therapy program
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

Locations

Country Name City State
Egypt South Valley University, Faculty of Physical Therapy Qina,

Sponsors (1)

Lead Sponsor Collaborator
South Valley University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

Gatica-Rojas V, Méndez-Rebolledo G, Guzman-Muñoz E, Soto-Poblete A, Cartes-Velásquez R, Elgueta-Cancino E, Cofré Lizama LE. Does Nintendo Wii Balance Board improve standing balance? A randomized controlled trial in children with cerebral palsy. Eur J Phys — View Citation

Grasso R, Assaiante C, Prévost P, Berthoz A. Development of anticipatory orienting strategies during locomotor tasks in children. Neurosci Biobehav Rev. 1998 Jul;22(4):533-9. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary cadence (number) number of steps in each min. cadence assessed at day 0.
Primary cadence (number) number of steps in each min. cadence assessed at day 90.
Primary step length of affected side (cm) 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.
Primary step length of affected side (cm) 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.
Primary stride length of affected side(cm) 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.
Primary stride length of affected side(cm) 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.
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