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Virtual Reality versusTask-oriented for Gait in CP

Primary Purpose

Cerebral Palsy

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

selected physical therapy program

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring wii sport, task oriented training, hemiplegic cerebral palsy

Eligibility Criteria

7 Years - 9 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

South Valley University, Faculty of Physical Therapy

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

the control group

virtual reality

Task oriented

Arm Description

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 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 task oriented training for 30 min.

Outcomes

Primary Outcome Measures

cadence (number)

number of steps in each min.

cadence (number)

number of steps in each min.

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 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)

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 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)

Secondary Outcome Measures

Full Information

NCT ID

NCT04533789

First Posted

August 16, 2020

Last Updated

August 26, 2020

Sponsor

South Valley University

1. Study Identification

Unique Protocol Identification Number

NCT04533789

Brief Title

Virtual Reality versusTask-oriented for Gait in CP

Official Title

Wii Sport Games Versus Task-oriented Training on Gait in Children With Unilateral Cerebral Palsy

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Completed

Study Start Date

May 22, 2019 (Actual)

Primary Completion Date

May 22, 2020 (Actual)

Study Completion Date

July 29, 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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cerebral Palsy

Keywords

wii sport, task oriented training, hemiplegic cerebral palsy

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 task oriented training for 30 min. all groups treated for four successive months.

Masking

ParticipantInvestigator

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 (task oriented training)

Allocation

Randomized

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

the control group

Arm Type

Experimental

Arm Description

Arm Title

virtual reality

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

Task oriented

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

selected physical therapy program

Intervention Description

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

Primary Outcome Measure Information:

Title

cadence (number)

Description

number of steps in each min.

Time Frame

cadence assessed at day 0.

Title

cadence (number)

Description

number of steps in each min.

Time Frame

cadence assessed at day 90.

Title

step length of affected side (cm)

Description

distance between the point of initial contact of one foot and the point of initial contact of the opposite foot (cm)

Time Frame

step length assessed at day 0.

Title

step length of affected side (cm)

Description

distance between the point of initial contact of one foot and the point of initial contact of the opposite foot (cm)

Time Frame

step length assessed at day 90.

Title

stride length of affected side(cm)

Description

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)

Time Frame

stride length assessed at day 0.

Title

stride length of affected side(cm)

Description

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)

Time Frame

stride length assessed at day 90.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

7 Years

Maximum Age & Unit of Time

9 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mohammed E Ali, PhD student

Organizational Affiliation

South Valley University, Faculty of Physical Therapy

Official's Role

Principal Investigator

Facility Information:

Facility Name

South Valley University, Faculty of Physical Therapy

City

Qina,

ZIP/Postal Code

83523

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

25657696

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.

Results Reference

background

PubMed Identifier

19932621

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.

Results Reference

background

PubMed Identifier

9595566

Citation

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.

Results Reference

background

PubMed Identifier

27882910

Citation

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.

Results Reference

result

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Virtual Reality versusTask-oriented for Gait in CP

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