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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
34

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ankara City Hospital Bilkent

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 29, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 1, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 3, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 3, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 1, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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