Halliwick Concept on Motor Functions in Spastic CP

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

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.

Study Overview

• Status: Completed
• Conditions: Spastic Cerebral Palsy; Spastic Hemiplegic Cerebral Palsy
• Intervention / Treatment: Other: Aquatic Halliwick method; Procedure: Conventional physical therapy

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza
    • Al Ḩayy Ath Thāmin, Giza, Egypt, 12511
      • October 6 university hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A (Halliwick method group); Under water exercise program according to halliwick concept which will be applied as three sessions per week for three successive months. Underwater exercises will be performed under the supervision of a certified aquatic therapist. This practitioner will instruct the child in proper techniques for performing exercises while ensuring child's safety by using flotation devices, body boards or float belts when necessary. Also the pool where the children will perform underwater exercises will be equipped with ramps, chair lifts, stairs, and handrails to facilitate a child's ability to access the pool.	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).
Active Comparator: Group B (conventional physical therapy group); Conventional selected exercise program for 60 minutes , three sessions per week for three successive months aiming to improve the motor functions of the children in form of: (1) Neuro-developmental technique, (2) Back and abdominal exercises, (3) improving postural responses, (4) Flexibility exercises, (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 .	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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: October 6 University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Actual): September 8, 2021
• Study Completion (Actual): September 8, 2021

Study Registration Dates

• First Submitted: September 17, 2021
• First Submitted That Met QC Criteria: October 15, 2021
• First Posted (Actual): October 26, 2021

Study Record Updates

• Last Update Posted (Actual): October 26, 2021
• Last Update Submitted That Met QC Criteria: October 15, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Cerebral Palsy; Paralysis; Muscle Spasticity
• Other Study ID Numbers: Halliwick07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: all of the individual participant data collected during the trial and after deidentification
• IPD Sharing Time Frame: 6 Months after study publication
• IPD Sharing Access Criteria: Email: mohamed.magdy.pt@o6u.edu.eg
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No