Virtual Reality versusTask-oriented for Gait in CP

NCT ID: NCT04533789

Last Updated: 2020-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-22

Study Completion Date

2020-07-29

Brief Summary

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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

Detailed Description

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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.

Conditions

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Cerebral Palsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 task oriented training for 30 min.

all groups treated for four successive months.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
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 (task oriented training)

Study Groups

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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.

Group Type EXPERIMENTAL

selected physical therapy program

Intervention Type OTHER

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

virtual reality

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

Group Type EXPERIMENTAL

selected physical therapy program

Intervention Type OTHER

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

Task oriented

Group 3 the study group received the same physical therapy program 30 min. plus task oriented training for 30 min.

Group Type EXPERIMENTAL

selected physical therapy program

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

7 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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South Valley University

OTHER

Sponsor Role lead

Responsible Party

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Nehad Ahmed Youness Abo-zaid

Lecturer of physical therapy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohammed E Ali, PhD student

Role: PRINCIPAL_INVESTIGATOR

South Valley University, Faculty of Physical Therapy

Locations

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South Valley University, Faculty of Physical Therapy

Qina, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 25657696 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19932621 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9595566 (View on PubMed)

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.

Reference Type RESULT
PMID: 27882910 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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P.T.REC/012/001729

Identifier Type: -

Identifier Source: org_study_id

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