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

May 1, 2024 updated by: Emel TURGUT VARAN, Ankara City Hospital Bilkent
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Emel Turgut Varan, Medical Doctor

Study Locations

  • Turkey
    • Ankara, Bilkent-Çankaya
      • Ankara, Ankara, Bilkent-Çankaya, Turkey, 06800
        • Recruiting
        • Ankara Bilkent City Hospital Physical Therapy and Rehabilitation Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: conventional rehabilitation
17 cerebral palsy patients will be included in the conventional rehabilitation program.
Other: conventional rehabilitation
17 patients with cerebral palsy meeting the criteria will undergo conventional rehabilitation
Active Comparator: conventional rehabilitation and aquatic therapy
17 cerebral palsy patients will be included in the conventional rehabilitation and aquatic therapy program.
Other: aquatic therapy
17 patients with cerebral palsy meeting the criteria will undergo convertional rehabilitation and aquatic therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Ashworth Scale (MAS)
Time Frame: baseline, after 1 month and 3 month changes.
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
Time Frame: baseline, after 1 month and 3 month changes.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pediatric Balance Scale
Time Frame: baseline, after 1 month and 3 month changes.
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.
The Functional Reach Test
Time Frame: baseline, after 1 month and 3 month changes.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara City Hospital Bilkent

Investigators

  • Principal Investigator: Emel Turgut Varan, Medical Doctor, Ankara Bilkent City Hospital
  • Study Director: Özlem Yılmaz Taşdelen, Professor Doctor, Ankara Bilkent City Hospital
  • Study Chair: Evren Yaşar, Professor Doctor, Ankara Bilkent City Hospital
  • Study Chair: Hacer Han, Physical therapist, Ankara Bilkent City Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Estimated)

July 30, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

April 29, 2024

First Submitted That Met QC Criteria

May 1, 2024

First Posted (Actual)

May 3, 2024

Study Record Updates

Last Update Posted (Actual)

May 3, 2024

Last Update Submitted That Met QC Criteria

May 1, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10026545

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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