Halliwick Concept on Motor Functions in Spastic CP

Sponsor

October 6 University (Other)

Overall Status

Completed

CT.gov ID

NCT05094921

Collaborator

(none)

Enrollment

Location

Arms

3.3

Actual Duration (Months)

11.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Spastic Cerebral Palsy Spastic Hemiplegic Cerebral Palsy	Other: Aquatic Halliwick method Procedure: Conventional physical therapy	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 1, 2021

Actual Primary Completion Date :

Sep 8, 2021

Actual Study Completion Date :

Sep 8, 2021

Arms and Interventions

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 .

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 .

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 9 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	October 6 University Hospital	Al Ḩayy Ath Thāmin	Giza	Egypt	12511

Sponsors and Collaborators

October 6 University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mohamed Magdy Ali Hassan ElMeligie, Principal investigator, October 6 University

ClinicalTrials.gov Identifier:

NCT05094921

Other Study ID Numbers:

Halliwick07

First Posted:

Oct 26, 2021

Last Update Posted:

Oct 26, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Muscle Spasticity

Paralysis

Cerebral Palsy

Study Results

No Results Posted as of Oct 26, 2021