Halliwick Concept on Motor Functions in Spastic CP

NCT05094921 | Completed

• 1 other identifier: Halliwick07
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Spastic Cerebral Palsy; Spastic Hemiplegic Cerebral Palsy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Group A (Halliwick method group)

EXPERIMENTAL

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

Group B (conventional physical therapy group)

ACTIVE COMPARATOR

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

Interventions

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).

Group A (Halliwick method group)

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 .

Group B (conventional physical therapy group)

Eligibility Criteria

• Age: 5 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• October 6 University: lead

Study Sites (1)

October 6 University Hospital

Al Ḩayy Ath Thāmin, Giza Governorate, 12511, Egypt

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 17, 2021
• First Posted: October 26, 2021
• Study Start: June 1, 2021
• Primary Completion: September 8, 2021
• Study Completion: September 8, 2021
• Last Updated: October 26, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 6 Months after study publication
• Access Criteria: Email: mohamed.magdy.pt@o6u.edu.eg

Locations

EG (1)