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RecruitingNCT06398756Updated May 3, 2024

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

An interventional study of conventional rehabilitation and aquatic therapy in Cerebral Palsy, sponsored by Ankara City Hospital Bilkent. Recruiting at 1 site in Turkey. Open to participants aged 3 Years to 16 Years. Per ClinicalTrials.gov, last updated 2024-05-03.

Sponsored by Ankara City Hospital Bilkent · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jul 2024, 2 years 2 months ago, but the record still lists the study as recruiting.
  • Registered 7 months after the study started (first participant enrolled Sep 2023, registered Apr 2024).
  • Started Sep 2023; still recruiting 3 years 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
3 Years to 16 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cerebral Palsy

Browse trials for

Keywords

  • aquatic therapy
  • rehabiltation
03

In context

Cerebral Palsy

1,853 studies on the registry are indexed under Cerebral Palsy; 435 are open to participants now.

This study's planned enrollment of 34 is close to the median of 33 across 1,368 interventional studies indexed under Cerebral Palsy.

Browse Cerebral Palsy studies →

Lead sponsor

Ankara City Hospital Bilkent is the lead sponsor of 424 studies on the registry; 105 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
34 participants (estimated)

Study arms

  • Active comparator
    conventional rehabilitation

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

    Other: 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

Interventions

  • Otherconventional rehabilitation

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

  • Otheraquatic therapy

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: baseline, after 1 month and 3 month changes.

  2. 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.

    Time frame: baseline, after 1 month and 3 month changes.

Secondary outcomes

  1. 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.

    Time frame: baseline, after 1 month and 3 month changes.

  2. 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.

    Time frame: baseline, after 1 month and 3 month changes.

07

Study locations

1 of 1 sites recruiting
  • Ankara Bilkent City Hospital Physical Therapy and Rehabilitation Hospital
    Ankara, Ankara, Bilkent-Çankaya 06800, Turkey
    Recruiting
08

References and documents

Publications

  • 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. PubMed 27967298 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06398756
Lead sponsor
Ankara City Hospital Bilkent
Responsible party
Emel TURGUT VARAN (medical doctor, Ankara City Hospital Bilkent) — Principal investigator
First posted
May 3, 2024
Start date
Sep 1, 2023
Primary completion
Jul 30, 2024 (estimated)
Completion
Sep 2024 (estimated)
Last update
May 3, 2024

Study contacts

Özlem Yılmaz Taşdelen, Professor Doctor
Contact
dr.ozlemyilmaz@gmail.com
05056460390
Emel Turgut Varan, Medical Doctor
Contact
Emel Turgut Varan, Medical Doctor
principal investigator · Ankara City Hospital Bilkent
Özlem Yılmaz Taşdelen, Professor Doctor
study director · Ankara City Hospital Bilkent
Evren Yaşar, Professor Doctor
study chair · Ankara City Hospital Bilkent
Hacer Han, Physical therapist
study chair · Ankara City Hospital Bilkent

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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