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

NCT06398756 | Recruiting

• 1 other identifier: 10026545
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Keywords

aquatic therapy; rehabiltation

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (2)

• Pediatric Balance Scale

  baseline, after 1 month and 3 month changes.

• The Functional Reach Test

  baseline, after 1 month and 3 month changes.

Study Arms (2)

conventional rehabilitation

ACTIVE COMPARATOR

17 cerebral palsy patients will be included in the conventional rehabilitation program.

Other: conventional rehabilitation

conventional rehabilitation and aquatic therapy

ACTIVE COMPARATOR

17 cerebral palsy patients will be included in the conventional rehabilitation and aquatic therapy program.

Other: aquatic therapy

Interventions

conventional rehabilitation OTHER

17 patients with cerebral palsy meeting the criteria will undergo conventional rehabilitation

conventional rehabilitation

aquatic therapy OTHER

17 patients with cerebral palsy meeting the criteria will undergo convertional rehabilitation and aquatic therapy

conventional rehabilitation and aquatic therapy

Eligibility Criteria

• Age: 3 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Having a diagnosis of Hemiplegic Type or Diplegic Type Cerebral Palsy
• Being between the ages of 3 and 16
• Being at GMFCS levels I, II, and III
• Having sufficient cognitive abilities such as understanding simple instructions, following them, and performing requested tasks
• Parents and patients aged ≥ 9 agreeing to participate in the research

You may not qualify if:

• Experiencing uncontrolled seizures
• Having serious learning difficulties, behavioral problems, skin lesions, visual and/or hearing impairments that could affect function and participation
• Active infection
• Incontinence

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital Physical Therapy and Rehabilitation Hospital

Ankara, Ankara, Bilkent-Çankaya, 06800, Turkey (Türkiye)

RECRUITING

Related 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.

  PMID: 27967298 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Aquatic Therapy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Hydrotherapy; Physical Therapy Modalities; Therapeutics; Rehabilitation

Study Officials

• Emel Turgut Varan, Medical Doctor

  Ankara City Hospital Bilkent

  PRINCIPAL INVESTIGATOR

• Özlem Yılmaz Taşdelen, Professor Doctor

  Ankara City Hospital Bilkent

  STUDY DIRECTOR

• Evren Yaşar, Professor Doctor

  Ankara City Hospital Bilkent

  STUDY CHAIR

• Hacer Han, Physical therapist

  Ankara City Hospital Bilkent

  STUDY CHAIR

Central Study Contacts

Özlem Yılmaz Taşdelen, Professor Doctor

CONTACT

05056460390; dr.ozlemyilmaz@gmail.com

Emel Turgut Varan, Medical Doctor

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: medical doctor

Model Details: assignment

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: May 3, 2024
• Study Start: September 1, 2023
• Primary Completion: July 30, 2024
• Study Completion: September 1, 2024
• Last Updated: May 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)