Effect of Electrical Stimulation With Functional Task Training on Balance and Motor Abilities in Children With Diplegia

Cerebral Palsy Spastic Diplegia Clinical Trial

Official title:

Functional Task Training Combined With Electrical Stimulation on Balance and Motor Abilities in Children With Diplegia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06234215
• Other study ID #: E.S and balance in diplegia
• Status: Completed
• Phase: N/A
• Start date: January 17, 2023
• Est. completion date: November 25, 2023

Study information

• Verified date: January 2024
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aims of the study are to:

1. Investigate the combined effect of functional task training with electrical stimulation of bilateral hip abductor muscles on balance in children with diplegia.

2. Investigate the combined effect of functional task training with electrical stimulation of bilateral hip abductor muscles on motor abilities in children with diplegia.

Description:

Cerebral palsy (CP) is a group of permanent disorders of movement and posture. It is non-progressive lesion or abnormality of immature brain. The term cerebral refers to the brain and palsy refers to the loss or impairment of motor function.

Functional electrical stimulation (FES) is a subtype of neuromuscular electrical stimulation (NMES) in which the stimulation assists functional and purposeful movements. This is achieved by applying electrical stimulation to muscles that, when they contract, produce a movement that can be used functionally.The FES is used to provide electrical stimulation via the peripheral nervous system to activate muscle contractions to assist functional activities when nervous or musculo-skeletal systems are damaged.The common applications of FES include strengthening muscle, reducing muscle spasticity, increasing range of motion, improving upper extremity function and walking speed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 25, 2023
• Est. primary completion date: September 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 11 Years

Eligibility

Inclusion Criteria:

• Their ages will range from 7-11 years.

• Both genders will be included.

• Their degree of spasticity will range from 1 to 1+ according to Modified Ashworth Scale (Meseguer-Henarejos et al., 2018).

• Their motor function will be at level I & II according to Gross Motor Function --- -Classification system (Palisano et al., 2008).

• They will be understanding instructions.

Exclusion Criteria:

• Children will be excluded from the study if they have any of the following criteria:

Musculoskeletal fixed deformities in upper limb, lower limb or spine.

• Visual or hearing problems.

• Epilepsy.

• Botulinium toxin therapy or orthopedic surgery within the past 6months or within the study period.

Related Conditions & MeSH terms

• Cerebral Palsy
• Cerebral Palsy Spastic Diplegia

Intervention

Device:
• functional electrical stimulation
electrical stimulation during function

Other:
• functional task training
functional exercise

Locations

Country	Name	City	State
Egypt	?Randa Adel?	Itay Al Barud	El-beheira

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Humac balance system	static and dynamic balance when values inscrease the results are better.	two months
Secondary	Growth motor functional scale	measuring motor abilities standing and walking when values increase the results are better.	two months