Halliwick Concept on Motor Functions in Spastic CP

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.

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Key information

Conditions

Spastic Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Nervous System Diseases Spastic Hemiplegic Cerebral Palsy

Age range

5 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

October 6 University Hospital

Al Ḩayy Ath Thāmin, Giza Governorate, 12511, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aquatic Halliwick method

Other

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).

Conventional Physical Therapy

Procedure

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 .

Primary outcomes

Change from Gross motor function measure at 3 months [ Time Frame: 3 months ]

Time frame: 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).

Sponsors and collaborators

Lead sponsor

October 6 University

Other

Registry information

Official study title

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

Important dates

Study start: 2021
Primary completion: 2021
Study completion: 2021
First posted: Oct 26, 2021
Registry last updated: Oct 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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