Halliwick Concept on Motor Functions in Spastic CP

Not Applicable

Completed

• Conditions: Spastic Cerebral Palsy; Spastic Hemiplegic Cerebral Palsy

• Registration Number: NCT05094921
• Lead Sponsor: October 6 University

Brief Summary

This randomized controlled trial will investigate the effect of hydrotherapy (halliwick concept) on motor functions in children with spastic cerebral palsy (CP). Minimum of 30 Spastic CP children will be recruited for this study. Children will be randomly assigned into control group who will receive conventional selected exercise treatment or study group who will receive the same conventional program in addition to underwater exercise program. Motor function will be evaluated at baseline and after 3 months of treatment. No potential harms are expected during this study.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-01
• Primary Completion: 2021-09-08
• Study Completion: 2021-09-08
• Study First Submitted: 2021-09-17
• Status Verified: 2021-10
• Study First Submitted QC: 2021-10-15
• Last Update Submitted: 2021-10-15
• Study First Posted: 2021-10-26
• Last Update Posted: 2021-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Children from both sexes diagnosed with spastic CP according to a pediatrician
• The degree of spasticity will be determined as grade two or less according to modified Ashworth scale
• Their age will range from five to nine years
• Intelligence quotient score > 35 (no worse than moderate intellectual disability) as assessed via Wechsler test scales
• No severe psychosocial or behavioral problems, such high aggression or risk of self-harm.

Exclusion Criteria

• Initiation of oral antispastic medication
• botulinum toxin injections or surgery performed less than 90 days before enrollment
• severe visual or auditory impairment
• uncontrollable epilepsy (defined as the occurrence of seizures despite the use of at least one antiepileptic drug)
• open wounds
• children with a psychiatric disorder
• cognitive disorders evaluated by the pediatric evaluation of disability inventory
• uncontrolled epilepsy
• active infection
• severe cardiopulmonary disorders.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from Gross motor function measure at 3 months [ Time Frame: 3 months ]	Baseline and after 3 months	The Gross Motor Function Measure (GMFM) is an observational clinical tool designed to evaluate change in gross motor function in children with cerebral palsy. There are two versions of the GMFM - the original 88-item measure (GMFM-88) and the more recent 66-item GMFM (GMFM-66) The scoring system of the GMFM is a four-point scale divided into five categories (lying and rolling; sitting; crawling and kneeling; standing; walking, running).

Trial Locations

Locations (1)

October 6 University Hospital; 🇪🇬 Al Ḩayy Ath Thāmin, Giza, Egypt