Back to resultsHalliwick Concept on Motor Functions in Spastic CP
Primary Purpose
Spastic Cerebral Palsy, Spastic Hemiplegic Cerebral Palsy
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Aquatic Halliwick method
Conventional physical therapy
Sponsored by
About this trial
This is an interventional treatment trial for Spastic Cerebral Palsy
Eligibility Criteria
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.
Sites / Locations
- October 6 University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group A (Halliwick method group)
Group B (conventional physical therapy group)
Arm Description
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.
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 .
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT05094921
First Posted
September 17, 2021
Last Updated
October 15, 2021
Sponsor
October 6 University
1. Study Identification
Unique Protocol Identification Number
NCT05094921
Brief Title
Halliwick Concept on Motor Functions in Spastic CP
Official Title
Effect of Hydrotherapy (Halliwick Concept)on Motor Function in Spastic Cerebral Palsy: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
September 8, 2021 (Actual)
Study Completion Date
September 8, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
October 6 University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spastic Cerebral Palsy, Spastic Hemiplegic Cerebral Palsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A (Halliwick method group)
Arm Type
Experimental
Arm Description
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.
Arm Title
Group B (conventional physical therapy group)
Arm Type
Active Comparator
Arm Description
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 .
Intervention Type
Other
Intervention Name(s)
Aquatic Halliwick method
Intervention Description
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
Procedure
Intervention Name(s)
Conventional physical therapy
Intervention Description
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 .
Primary Outcome Measure Information:
Title
Change from Gross motor function measure at 3 months [ Time Frame: 3 months ]
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
October 6 University Hospital
City
Al Ḩayy Ath Thāmin
State/Province
Giza
ZIP/Postal Code
12511
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Learn more about this trial
Halliwick Concept on Motor Functions in Spastic CP
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