The Impact of Aquatic Therapy on Walking, Balance Functions, and Quality of Life in Children With Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

The Impact of Aquatic Therapy on Walking, Balance Functions, and Quality of Life in Children With Cerebral Palsy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06398756
• Other study ID #: 10026545
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: September 2024

Study information

• Verified date: May 2024
• Source: Ankara City Hospital Bilkent
• Contact: Özlem Yilmaz Tasdelen, Professor Doctor
• Phone: 05056460390
• Email: dr.ozlemyilmaz[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to contribute to the rehabilitation program by comparing the effects of traditional rehabilitation methods and aquatherapy given in addition to these methods in patients with cerebral palsy. If the superiority of the rehabilitation program including aquatherapy is demonstrated, evidence will be provided for its more widespread use.

Description:

The participants will be divided into two groups as the study group and the control group. The study group will receive an aquatherapy rehabilitation program in addition to the conventional rehabilitation program, while the control group will only receive the conventional rehabilitation program.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: September 2024
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 16 Years

Eligibility

Inclusion Criteria:

1. Having a diagnosis of Hemiplegic Type or Diplegic Type Cerebral Palsy

2. Being between the ages of 3 and 16

3. Being at GMFCS levels I, II, and III

4. Having sufficient cognitive abilities such as understanding simple instructions, following them, and performing requested tasks

5. Parents and patients aged = 9 agreeing to participate in the research

Exclusion Criteria:

1. Experiencing uncontrolled seizures

2. Having serious learning difficulties, behavioral problems, skin lesions, visual and/or hearing impairments that could affect function and participation

3. Active infection

4. Incontinence

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Other:
• conventional rehabilitation
17 patients with cerebral palsy meeting the criteria will undergo conventional rehabilitation
• aquatic therapy
17 patients with cerebral palsy meeting the criteria will undergo convertional rehabilitation and aquatic therapy

Locations

Country	Name	City	State
Turkey	Ankara Bilkent City Hospital Physical Therapy and Rehabilitation Hospital	Ankara	Ankara, Bilkent-Çankaya

Sponsors (1)

Lead Sponsor	Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Roostaei M, Baharlouei H, Azadi H, Fragala-Pinkham MA. Effects of Aquatic Intervention on Gross Motor Skills in Children with Cerebral Palsy: A Systematic Review. Phys Occup Ther Pediatr. 2017 Oct 20;37(5):496-515. doi: 10.1080/01942638.2016.1247938. Epub 2016 Dec 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Ashworth Scale (MAS)	MAS 0: No increase in tone MAS 1: Minimal resistance or a catch and release at the end of the range of motion MAS 1+: Slight increase in tone, with minimal resistance felt in less than half of the range of motion MAS 2: Increased tone throughout most of the range of motion, but the joint can be easily moved MAS 3: Marked increase in tone, making passive movement difficult MAS 4: Rigidity in flexion or extension of the affected part	baseline, after 1 month and 3 month changes.
Primary	Gross Motor Function Measurement	The Gross Motor Function Measurement (GMFM) is an assessment method used to determine the motor development level of children with cerebral palsy. Its purpose is to measure not just the quality of motor performance, but rather how much of the movement the child has accomplished.	baseline, after 1 month and 3 month changes.
Secondary	Pediatric Balance Scale	The Pediatric Balance Scale (PBS)" is a functional balance measure that evaluates postural control while children perform activities they commonly engage in at home, school, and within the community. It consists of a 14-item scale, with each item scored from 0 to 4. The maximum score is 56.	baseline, after 1 month and 3 month changes.
Secondary	The Functional Reach Test	The Functional Reach Test is one of the dynamic balance assessment methods. It measures the maximum distance one can reach forward and sideways while standing upright.	baseline, after 1 month and 3 month changes.