Cerebral PalsyNCT05753345
Aquatic Therapy for Children With Neuromotor Deficits
A study testing Aquatic therapy in people with Cerebral Palsy and Hypoxia, Brain, run by Ohio State University at 1 site in United States.
Trial summary
The purpose of this study is to explore the feasibility, fidelity and acceptability of an aquatic therapy assessment and intervention for children ages 3-9 with neuromotor deficits such as cerebral palsy. Read more about this study
- Who is it for?
- Ages 3 to 9 years
- Conditions the study is for
- Cerebral Palsy, Hypoxia, Brain
- What is being tested?
- Aquatic therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2023to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 3-9 years for the children, 18+ for the parents/guardians.
- child with neuro-motor diagnosis (CP, hypoxia, etc.)
- child impairments in upper extremity function
- child deficits in performance of self care activities
Who cannot join
- compromised airway
- uncontrolled seizures
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to explore the feasibility, fidelity and acceptability of an aquatic therapy assessment and intervention for children ages 3-9 with neuromotor deficits such as cerebral palsy. The intervention takes place in a warm water therapy pool, twice a week for ten weeks and targets swim safety skills, upper extremity function and self care participation and performance.
Read the detailed description
The purpose of this study is to explore the feasibility, fidelity and acceptability of an aquatic therapy assessment and intervention. The intervention will target swim safety skills, upper extremity function and self care participation and performance in children with neuromotor conditions such as cerebral palsy. The study includes an intake evaluation session, twenty sessions of aquatic therapy (twice a week for 10 weeks) and a post evaluation session. This takes place in Columbus, Ohio.
Each session will be a combination of land-based self care training and water-based upper extremity exercise and swim skill training. The intervention structure will include the following:
- Self Care Session: Doffing clothing, preparing for swimming
- Motor learning aquatic activities guided by individualized goals
- Self Care session: Towel dry, rinse off, dressing
Individualized activities will be planned according to the individualized goals written for each child participant.
- Conditions
- Cerebral Palsy, Hypoxia, Brain
- Being tested
- Aquatic therapy
- Medical subject headings
- Cerebral Palsy, Hypoxia, Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aquatic therapyBehavioural
Children receive aquatic occupational therapy twice a week for 10 weeks. 30 minutes of aquatic therapy in a warm water pool to increase upper extremity function and swim skills; 15 minutes of self care training to increase independence with dressing and showering.
| Study group | Role | What they receive |
|---|---|---|
| Intervention: aquatic occupational therapy (AquOTic-NM) | Experimental | aquatic occupational therapy 30 minutes, self care training 15 minutes Receives: Behavioral: Aquatic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Water Orientation Test Alyn (WOTA)
performance based swim skill assessment
Measured: Baseline, immediately after the intervention
Change in Pediatric Evaluation of Disability Index, Computer Adaptive Text (PEDI-CAT)
parent reported questionnaire regarding child's self care skills
Measured: baseline, immediately after the intervention
Change in Quality of Upper Extremity Skills Test (QUEST)
performance-based assessment of upper extremity skills
Measured: baseline, immediately after intervention
Secondary outcomes (2)
Change in Participation and Environment Measure (PEM-CY)
parent reported questionnaire of participation in home, school and community
Measured: baseline, immediately after the intervention
Change in Canadian Occupational Performance Measure (COPM)
Parent perception of goals attained
Measured: baseline, immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2023
- Study start9 Jan 2023
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- Franklin County Board of Developmental Disabilities
- Responsible party
- Principal investigator, Erika Kemp, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05753345
- Sponsor's protocol ID
- 2022H0340
- Status last verified
- Jun 2026
- First submitted
- 3 Feb 2023
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Deidentified data may be shared with researchers upon request
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aquatic Therapy for Children With Neuromotor Deficits
- ClinicalTrials.gov ID
- NCT05753345
- Acronym / sponsor ID
- 2022H0340
- Conditions
- Cerebral Palsy, Hypoxia, Brain
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- Franklin County Board of Developmental Disabilities
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 3 Mar 2023 (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 this study is to explore the feasibility, fidelity and acceptability of an aquatic therapy assessment and intervention for children ages 3-9 with neuromotor deficits such as cerebral palsy. The intervention takes place in a warm water therapy pool, twice a week for ten weeks and targets swim safety skills, upper extremity function and self care participation and performance.
Detailed description
The purpose of this study is to explore the feasibility, fidelity and acceptability of an aquatic therapy assessment and intervention. The intervention will target swim safety skills, upper extremity function and self care participation and performance in children with neuromotor conditions such as cerebral palsy. The study includes an intake evaluation session, twenty sessions of aquatic therapy (twice a week for 10 weeks) and a post evaluation session. This takes place in Columbus, Ohio.
Each session will be a combination of land-based self care training and water-based upper extremity exercise and swim skill training. The intervention structure will include the following:
- Self Care Session: Doffing clothing, preparing for swimming
- Motor learning aquatic activities guided by individualized goals
- Self Care session: Towel dry, rinse off, dressing
Individualized activities will be planned according to the individualized goals written for each child participant.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention: aquatic occupational therapy (AquOTic-NM) | Experimental | Behavioral: Aquatic therapyaquatic occupational therapy 30 minutes, self care training 15 minutes |
Who may qualify
- Ages
- 3 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 3-9 years for the children, 18+ for the parents/guardians.
- child with neuro-motor diagnosis (CP, hypoxia, etc.)
- child impairments in upper extremity function
- child deficits in performance of self care activities
Key exclusion criteria (2 listed)
- compromised airway
- uncontrolled seizures
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 |
|---|---|---|
| Aquatic therapyChildren receive aquatic occupational therapy twice a week for 10 weeks. 30 minutes of aquatic therapy in a warm water pool to increase upper extremity function and swim skills; 15 minutes of self care training to increase independence with dressing and showering. | Behavioural | Intervention: aquatic occupational therapy (AquOTic-NM) |
Primary outcome
Change in Water Orientation Test Alyn (WOTA)
Time frame: Baseline, immediately after the intervention
performance based swim skill assessment
Change in Pediatric Evaluation of Disability Index, Computer Adaptive Text (PEDI-CAT)
Time frame: baseline, immediately after the intervention
parent reported questionnaire regarding child's self care skills
Change in Quality of Upper Extremity Skills Test (QUEST)
Time frame: baseline, immediately after intervention
performance-based assessment of upper extremity skills
2 secondary outcomes
Change in Participation and Environment Measure (PEM-CY)
Time frame: baseline, immediately after the intervention
Change in Canadian Occupational Performance Measure (COPM)
Time frame: baseline, immediately after the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Individual participant dataSharing planned: No. Deidentified data may be shared with researchers upon request
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aquatic therapy in people with Cerebral Palsy and Hypoxia, Brain, run by Ohio State University at 1 site in United States.
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 4 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 30 Jun 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Water Orientation Test Alyn (WOTA) (time frame: Baseline, immediately after the intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jun 2026.