Virtual Reality Versus Mirror Therapy on Balance and Muscle Strength in Children With Hemiplegic Cerebral Palsy

Sponsor

October 6 University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05331703

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Previous research has demonstrated balance deficits ranging from 28%-43% depending on the nature of the balance task in individuals with CP compared to controls (Kenis-Coskun et al., 2016). As balance is critical for underlying normal movement, improvements in static and dynamic balance are important goals in rehabilitation for ambulatory children with CP (Saether et al., 2013).

Balance deficits are among the symptoms that having a more profound impact on motor function and quality of life inn with CP children (Lai et al., 2017). Poor balance reduces the ability to perform gait-related activities and increases the risk of falling, which, in turn, limits participation in daily activities, including sports and physical activities (Usuba et al., 2015).

Condition or Disease	Intervention/Treatment	Phase
Rehabilitation	Other: designed physical therapy program in addition to program of virtual reality. Other: designed physical therapy program in addition to program of mirror therapy.	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Virtual Reality Versus Mirror Therapy on Balance and Muscle Strength in Children With Hemiplegic Cerebral Palsy

Anticipated Study Start Date :

Dec 22, 2022

Anticipated Primary Completion Date :

Mar 22, 2023

Anticipated Study Completion Date :

Dec 22, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: group A will receive a designed physical therapy program in addition to program of virtual reality	Other: designed physical therapy program in addition to program of virtual reality. physical therapy program in addition to program of virtual reality.
Experimental: group B will receive a designed physical therapy program in addition to program of mirror therapy.	Other: designed physical therapy program in addition to program of mirror therapy. physical therapy program in addition to program of mirror therapy.

Arm

Intervention/Treatment

Experimental: group A

will receive a designed physical therapy program in addition to program of virtual reality

Other: designed physical therapy program in addition to program of virtual reality.

physical therapy program in addition to program of virtual reality.

Experimental: group B

will receive a designed physical therapy program in addition to program of mirror therapy.

Other: designed physical therapy program in addition to program of mirror therapy.

physical therapy program in addition to program of mirror therapy.

Outcome Measures

Primary Outcome Measures

Biodex balance system [3 months]
The Biodex balance System to measures postural stability under dynamic stress.
Hand held dynamometer [3 months]
The hand held dynamometry to measure muscle strength of non-disabled children

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 10 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Their ages will range from 6 to 10 years old.
The degree of spasticity will range from 1+ to 2 grades according to Modified Ashworth scale (NUMANO and Günel, 2011) (Appendix II).
They will be on level I and II on Gross Motor Function Classification System (GMFCS) (Palisano et al., 2008) (Appendix III).
Their heights will be one meter or more.
They will be able to follow the verbal commands or instructions.

Exclusion Criteria:

Severe visual or auditory problems.
Epilepsy.
History of surgical interference in lower limbs.
Botulinum toxin injections of the lower limbs during the previous six

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Emad Eldin	Cairo	October	Egypt	8124

Sponsors and Collaborators

October 6 University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

samar salem, assistant professor at faculty of physical therapy at October 6 university, October 6 University

ClinicalTrials.gov Identifier:

NCT05331703

Other Study ID Numbers:

P.T.REC/012/0035A342

First Posted:

Apr 18, 2022

Last Update Posted:

Apr 18, 2022

Last Verified:

Apr 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Cerebral Palsy

Study Results

No Results Posted as of Apr 18, 2022