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CompletedNCT05094921Updated Oct 26, 2021

Halliwick Concept on Motor Functions in Spastic CP

An interventional study of Aquatic Halliwick method and Conventional physical therapy in Spastic Cerebral Palsy and Spastic Hemiplegic Cerebral Palsy, sponsored by October 6 University. Completed at 1 site in Egypt. Open to participants aged 5 Years to 9 Years. Per ClinicalTrials.gov, last updated 2021-10-26.

Sponsored by October 6 University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Jun 2021, registered Sep 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
5 Years to 9 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Spastic Cerebral Palsy
  • Spastic Hemiplegic Cerebral Palsy
03

In context

Muscle Spasticity

704 studies on the registry are indexed under Muscle Spasticity; 149 are open to participants now.

This study's enrollment of 36 is close to the median of 36 across 525 interventional studies indexed under Muscle Spasticity.

Browse Muscle Spasticity studies →

Lead sponsor

October 6 University is the lead sponsor of 135 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 9 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
36 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • OtherAquatic 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).

  • ProcedureConventional 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 .

06

What researchers measure

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).

    Time frame: Baseline and after 3 months

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Study locations

1 site
  • October 6 University Hospital
    Al Ḩayy Ath Thāmin, Giza 12511, Egypt
08

References and documents

Individual participant data

Plan to share: Yes — all of the individual participant data collected during the trial and after deidentification

Supporting information: Study protocol, Sap, Icf

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 26, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05094921
Lead sponsor
October 6 University
Responsible party
Mohamed Magdy Ali Hassan ElMeligie (Principal investigator, October 6 University) — Principal investigator
First posted
Oct 26, 2021
Start date
Jun 1, 2021
Primary completion
Sep 8, 2021
Completion
Sep 8, 2021
Last update
Oct 26, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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