Cerebral PalsyNCT06398756
The Impact of Aquatic Therapy on Walking, Balance Functions, and Quality of Life in Children With Cerebral Palsy
A study testing conventional rehabilitation and aquatic therapy in people with Cerebral Palsy, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 16 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- conventional rehabilitation and aquatic therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2023to Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Emel Turgut Varan, Medical Doctor contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Bilkent City Hospital Physical Therapy and Rehabilitation Hospital
Ankara, Ankara, Bilkent-Çankaya, 06800
Emel Turgut Varan, Medical Doctor, +905466674562, emeltrgtemel@gmail.com
About this study
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.
- Conditions
- Cerebral Palsy
- Being tested
- conventional rehabilitation, aquatic therapy
- Keywords
- aquatic therapy, rehabiltation
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional rehabilitationOther
17 patients with cerebral palsy meeting the criteria will undergo conventional rehabilitation
aquatic therapyOther
17 patients with cerebral palsy meeting the criteria will undergo convertional rehabilitation and aquatic therapy
| Study group | Role | What they receive |
|---|---|---|
| conventional rehabilitation | Active comparator | 17 cerebral palsy patients will be included in the conventional rehabilitation program. Receives: 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. Receives: Other: aquatic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: baseline, after 1 month and 3 month changes.
Secondary outcomes (2)
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.
Measured: baseline, after 1 month and 3 month changes.
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.
Measured: baseline, after 1 month and 3 month changes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start1 Sep 2023
- Primary completion30 Jul 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- assignment
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emel TURGUT VARAN, Ankara City Hospital Bilkent
- Investigators
- Emel Turgut Varan, Medical Doctor, Principal investigator, Ankara City Hospital BilkentÖzlem Yılmaz Taşdelen, Professor Doctor, Study director, Ankara City Hospital BilkentEvren Yaşar, Professor Doctor, Study chair, Ankara City Hospital BilkentHacer Han, Physical therapist, Study chair, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06398756
- Sponsor's protocol ID
- 10026545
- Status last verified
- May 2024
- First submitted
- 29 Apr 2024
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Aquatic Therapy on Walking, Balance Functions, and Quality of Life in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06398756
- Acronym / sponsor ID
- 10026545
- Conditions
- Cerebral Palsy
- Keywords
- aquatic therapy, rehabiltation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 30 Jul 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 3 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- assignment
| Arm | Type | Receives |
|---|---|---|
| conventional rehabilitation | Active comparator | Other: conventional rehabilitation17 cerebral palsy patients will be included in the conventional rehabilitation program. |
| conventional rehabilitation and aquatic therapy | Active comparator | Other: aquatic therapy17 cerebral palsy patients will be included in the conventional rehabilitation and aquatic therapy program. |
Who may qualify
- Ages
- 3 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| conventional rehabilitation17 patients with cerebral palsy meeting the criteria will undergo conventional rehabilitation | Other | conventional rehabilitation |
| aquatic therapy17 patients with cerebral palsy meeting the criteria will undergo convertional rehabilitation and aquatic therapy | Other | conventional rehabilitation and aquatic therapy |
Primary outcome
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
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.
2 secondary outcomes
Pediatric Balance Scale
Time frame: baseline, after 1 month and 3 month changes.
The Functional Reach Test
Time frame: baseline, after 1 month and 3 month changes.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- Background: PubMed 27967298Roostaei 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional rehabilitation and aquatic therapy in people with Cerebral Palsy, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Özlem Yılmaz Taşdelen, Professor Doctor (05056460390, dr.ozlemyilmaz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Ashworth Scale (MAS) (time frame: baseline, after 1 month and 3 month changes.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06398756, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2024.