Halliwick Concept on Motor Functions in Spastic CP

Spastic Cerebral Palsy Clinical Trial

Official title:

Effect of Hydrotherapy (Halliwick Concept)on Motor Function in Spastic Cerebral Palsy: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05094921
• Other study ID #: Halliwick07
• Status: Completed
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: September 8, 2021

Study information

• Verified date: October 2021
• Source: October 6 University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: September 8, 2021
• Est. primary completion date: September 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 9 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Palsy
• Muscle Spasticity
• Paralysis
• Spastic Cerebral Palsy
• Spastic Hemiplegic Cerebral Palsy

Intervention

Other:
• Aquatic Halliwick method
The Halliwick Concept is a detailed swimming programme based on the scientific principles of body mechanics and the properties of water intended to educate individuals with special needs to be water safe and to move independently in the water as much as possible (Lambeck & Stanat 2001a).The programme consists of 10 specific progressive stages that are achieved without the use of floatation devices (Lambeck & Stanat 2001b).

Procedure:
• Conventional physical therapy
Conventional selected exercise program for 60 minutes ,3 session per week for 3 successive months aiming to improve the motor functions of the children in form of: (1) Neuro-developmental technique, (2) Back and abdominal exercises to improve postural control and correct spinal deformities (3) improving postural responses, (4) Flexibility exercises of the soft tissue (5) Strengthening exercise (particularly knee extensors, hip abductors and the ankle dorsi-flexors muscles and (6) Improving standing, weight transfer and shift and finally facilitation of normal walking pattern .

Locations

Country	Name	City	State
Egypt	October 6 University Hospital	Al ?ayy Ath Thamin	Giza

Sponsors (1)

Lead Sponsor	Collaborator
October 6 University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Gross motor function measure at 3 months [ Time Frame: 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).	Baseline and after 3 months