Halliwick Concept on Motor Functions in Spastic CP

NCT ID: NCT05094921

Last Updated: 2021-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2021-09-08

Brief Summary

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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

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Conditions

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Spastic Cerebral Palsy Spastic Hemiplegic Cerebral Palsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Aquatic Halliwick method

Intervention Type 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 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 .

Group Type ACTIVE_COMPARATOR

Conventional physical therapy

Intervention Type 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 .

Interventions

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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).

Intervention Type OTHER

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 .

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

5 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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October 6 University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Magdy Ali Hassan ElMeligie

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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October 6 University Hospital

Al Ḩayy Ath Thāmin, Giza Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Halliwick07

Identifier Type: -

Identifier Source: org_study_id