Clinical trial NCT06398756: The Impact of Aquatic Therapy on Walking, Balance Functions, and Quality of Life in Children With Cerebral Palsy
Official title: The Impact of Aquatic Therapy on Walking, Balance Functions, and Quality of Life in Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cerebral Palsy
Keywords: aquatic therapy
rehabiltation
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2024-05-03
Enrollment: 34
Sex: ALL
Minimum age (years): 3
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: assignment
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Modified Ashworth Scale (MAS)
timeFrame: baseline, after 1 month and 3 month changes.
measure: Gross Motor Function Measurement
timeFrame: baseline, after 1 month and 3 month changes.
Secondary outcomes:
measure: Pediatric Balance Scale
timeFrame: baseline, after 1 month and 3 month changes.
measure: The Functional Reach Test
timeFrame: baseline, after 1 month and 3 month changes.
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital Physical Therapy and Rehabilitation Hospital
state: Ankara, Bilkent-Çankaya
Study officials:
affiliation: Ankara City Hospital Bilkent
name: Emel Turgut Varan, Medical Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Ankara City Hospital Bilkent
name: Özlem Yılmaz Taşdelen, Professor Doctor
role: STUDY_DIRECTOR
affiliation: Ankara City Hospital Bilkent
name: Evren Yaşar, Professor Doctor
role: STUDY_CHAIR
affiliation: Ankara City Hospital Bilkent
name: Hacer Han, Physical therapist
role: STUDY_CHAIR
References:
citation: 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.