Cerebral Palsy (CP)NCT07690722
Effect of Whirlpool Therapy Combined With Botulinum Toxin in Children With Cerebral Palsy
A study testing Conventional Rehabilitation and Whirlpool Therapy in people with Cerebral Palsy (CP) and Cerebral Palsy, Hemiplegic, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study aims to investigate the effects of adding whirlpool therapy to standard rehabilitation in children with cerebral palsy who recently received botulinum toxin-A injections. Read more about this study
- Who is it for?
- Ages 3 to 10 years
- Conditions the study is for
- Cerebral Palsy (CP), Cerebral Palsy, Hemiplegic
- What is being tested?
- Conventional Rehabilitation and Whirlpool Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2025to 31 May 2026
- 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 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of hemiplegic cerebral palsy
- Age between 3 and 10 years
- Gross Motor Function Classification System (GMFCS) levels I-II
- Sufficient cognitive level to follow instructions
- Ability to walk at least 10 meters with an orthosis and/or walking aid
- Receipt of botulinum toxin injection to the lower extremity within the past week
- Ability to walk independently for 1 minute without orthosis or assistive device
Who cannot join
- Uncontrolled epilepsy
- Urinary incontinence
- Presence of lower extremity contractures
- History of previous orthopedic surgery
- Presence of hip subluxation
- Ataxic or dyskinetic cerebral palsy
- History of any botulinum toxin injection within the 6 months prior to the current 1-week post-injection period
- Inability to cooperate during clinical assessments
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Etlik City Hospital
Ankara, Ankara, 06010
About this study
Official title: Investigation of the Effects of Combining Whirlpool Therapy With Botulinum Toxin Treatment on Spasticity, Gait, and Motivation in Children With Cerebral Palsy
This study aims to investigate the effects of adding whirlpool therapy to standard rehabilitation in children with cerebral palsy who recently received botulinum toxin-A injections. Participants will be divided into two groups: one group will receive standard physiotherapy, while the other group will receive physiotherapy combined with whirlpool therapy. The effects of these interventions on spasticity, gait function, and motivation will be evaluated over a 12-week follow-up period.
Read the detailed description
This study was designed as a prospective, randomized, single-blind (assessor-blinded), parallel-group controlled clinical trial investigating the effects of combining whirlpool therapy with botulinum toxin type A (BoNT-A)-assisted rehabilitation on spasticity, gait, and motivation in children with hemiplegic cerebral palsy.
A total of 81 patients with hemiplegic cerebral palsy who had received botulinum toxin type A (BoNT-A) injections to selected lower extremity muscles within the previous week were initially evaluated. After applying the inclusion and exclusion criteria, 43 participants were enrolled in the study, and 38 patients were excluded. All botulinum toxin injections were performed using onabotulinumtoxinA by an experienced physiatrist with more than five years of clinical experience. Injection planning was individualized according to body weight, severity of spasticity, and targeted muscle groups.
Participants were randomly assigned in a 1:1 ratio to two groups (22 in the intervention group and 21 in the control group). Randomization was performed using a computer-generated random sequence by an independent researcher who was not involved in treatment or assessment. Allocation concealment was ensured using sequentially numbered, opaque, sealed envelopes. The study was conducted as a single-blind trial in which the outcome assessors were blinded to group allocation, while participants and therapists were not blinded because of the nature of the intervention.
Both groups received a conventional rehabilitation program for 4 weeks, 5 days per week, 1 hour per day. The program included range of motion (ROM) exercises for the upper and lower extremities, stretching and strengthening exercises, balance and coordination training, endurance exercises, and ambulation training, all delivered under physiotherapist supervision according to a standardized protocol.
In addition to conventional rehabilitation, the intervention group received whirlpool therapy three times per week for 4 weeks, with each session lasting 20 minutes, for a total of 12 sessions. All whirlpool therapy sessions were conducted under physiotherapist supervision.
Outcome measures were assessed at three time points: baseline (T0, week 0, pre-treatment), post-treatment (T1, week 4), and follow-up (T2, week 12). Spasticity was evaluated using the Modified Ashworth Scale (MAS) and the Modified Tardieu Scale (MTS). Functional mobility and standing/walking abilities were assessed using the Gross Motor Function Measure-88 (GMFM-88) dimensions D and E. Motivation was evaluated using the Pediatric Motivation Scale. Gait kinematics, including joint range of motion and peak flexion and extension angles of the hip, knee, and ankle, were analyzed using the DIERS 4D Motion Lab system. Functional walking performance was assessed using the 10-Meter Walk Test (10MWT).
- Conditions
- Cerebral Palsy (CP), Cerebral Palsy, Hemiplegic
- Being tested
- Conventional Rehabilitation, Whirlpool Therapy
- Keywords
- Cerebral Palsy, Hemiplegic Cerebral Palsy, Botulinum Toxin A, Spasticity, Whirlpool Therapy, Hydrotherapy, Gait Analysis, Rehabilitation
- Medical subject headings
- Cerebral Palsy, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional RehabilitationBehavioural
Standard rehabilitation program including range of motion exercises, stretching, strengthening, balance, coordination, endurance, and gait training, 5 days per week for 4 weeks under physiotherapist supervision.
Whirlpool TherapyOther
Whirlpool therapy administered 3 times per week for 4 weeks, 20 minutes per session (total 12 sessions), in addition to conventional rehabilitation.
| Study group | Role | What they receive |
|---|---|---|
| Botulinum Toxin + Conventional Physiotherapy + Whirlpool Therapy | Experimental | Patients receiving 4 weeks of conventional physical therapy combined with whirlpool therapy (20 minutes per session, 3 times per week). Receives: Behavioral: Conventional Rehabilitation; Other: Whirlpool Therapy |
| Botulinum Toxin + Conventional Physiotherapy | Active comparator | Patients receiving 4 weeks of conventional physical therapy alone. Receives: Behavioral: Conventional Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gross Motor Function Measure-88 (GMFM-88) - Dimension E (Walking, Running and Jumping)
The primary outcome measure was the Gross Motor Function Measure-88 (GMFM-88) Dimension E, which evaluates walking, running, and jumping abilities in children with hemiplegic cerebral palsy. Each item is scored on a 4-point scale (0-3), and raw scores are converted to percentage values (0-100). Dimension E consists of 24 items, with a maximum raw score of 72 points.
Measured: Baseline (Week 0), Week 4 (post-treatment), Week 12 (follow-up)
Secondary outcomes (6)
Modified Ashworth Scale (MAS)
Spasticity was assessed using the MAS. Scores were recorded for the hamstring, gastrocnemius, and adductor muscles of the affected side. The MAS is a 6-point ordinal scale (0, 1, 1+, 2, 3, and 4) used to assess resistance to passive movement, with higher scores indicating greater muscle spasticity.
Measured: Week 0, Week 4, Week 12
Pediatric Motivation Scale
Motivation was assessed using the Pediatric Motivation Scale (PMS), a validated self-report instrument designed to evaluate children's motivation toward rehabilitation. The scale consists of 21 items and includes six domains: effort-importance, interest-enjoyment, competence, relatedness, autonomy, and value-usefulness. The first 19 items are rated on a 6-point Likert scale ranging from 1 ("not at all true") to 6 ("very true"), while the remaining two items are open-ended questions. Total and domain scores are calculated from the Likert-scale items. Higher scores indicate greater motivation, stronger engagement in rehabilitation activities, and a higher degree of internally regulated motivation.
Measured: Week 4, Week 12
DIERS 4D Motion Analysis System
Three-dimensional gait kinematics were assessed using the DIERS 4D motion analysis system. Maximum hip, knee, and ankle flexion and extension angles of the hemiparetic limb were recorded. Additionally, bilateral knee valgus and varus angles were measured during gait. All data were automatically stored in the system memory for further analysis.
Measured: Baseline (Week 0), Week 4, Week 12
10-Meter Walk Test (10MWT)
Walking performance was assessed using the 10MWT. Participants walked a 10-meter straight path at their comfortable walking speed. Time was recorded in seconds, and gait speed (m/s) and cadence (steps/min) were calculated. Two trials were performed, and the best performance was recorded.
Measured: Baseline (Week 0), Week 4, Week 12
Gross Motor Function Measure-88 (GMFM-88) - Dimension D (Standing)
The GMFM-88 Dimension D was used to assess standing ability in children with hemiplegic cerebral palsy. This domain consists of 13 items evaluating static and dynamic standing activities. Each item is scored on a 4-point scale (0-3), and raw scores are converted to percentage values (0-100) based on the maximum achievable score.
Measured: Baseline (Week 0), Week 4, Week 12
Modified Tardieu Scale (MTS)
Spasticity was assessed using the MTS for the hamstring and gastrocnemius muscles of the affected side. Passive movement was performed at V1 (slow velocity) and V3 (fast velocity). Muscle reaction quality, R1, R2, and R2-R1 values were recorded.
Measured: Week 0, Week 4, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study start1 Feb 2025
- Primary completion1 May 2026
- Study completion31 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy (CP)Studies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe 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
- This study is a two-arm, parallel-group randomized controlled trial. Participants with hemiplegic cerebral palsy who received recent botulinum toxin-A injections were allocated in a 1:1 ratio to either a conventional physiotherapy group or a conventional physiotherapy plus whirlpool therapy group. The study evaluates the additional effect of whirlpool therapy on rehabilitation outcomes.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, AYŞENUR GENÇER ÖZTÜRK, Ankara Etlik City Hospital
- Investigators
- DAMLA CANKURTARAN, MD, Principal investigator, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07690722
- Sponsor's protocol ID
- AEŞH-EK1-2025-046
- Status last verified
- Jul 2026
- First submitted
- 13 Jun 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Combining Whirlpool Therapy With Botulinum Toxin Treatment on Spasticity, Gait, and Motivation in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT07690722
- Acronym / sponsor ID
- AEŞH-EK1-2025-046
- Conditions
- Cerebral Palsy (CP), Cerebral Palsy, Hemiplegic
- Keywords
- Cerebral Palsy, Hemiplegic Cerebral Palsy, Botulinum Toxin A, Spasticity, Whirlpool Therapy, Hydrotherapy, Gait Analysis, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 31 May 2026 (actual)
- First posted
- 8 Jul 2026 (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.
This study aims to investigate the effects of adding whirlpool therapy to standard rehabilitation in children with cerebral palsy who recently received botulinum toxin-A injections. Participants will be divided into two groups: one group will receive standard physiotherapy, while the other group will receive physiotherapy combined with whirlpool therapy. The effects of these interventions on spasticity, gait function, and motivation will be evaluated over a 12-week follow-up period.
Detailed description
This study was designed as a prospective, randomized, single-blind (assessor-blinded), parallel-group controlled clinical trial investigating the effects of combining whirlpool therapy with botulinum toxin type A (BoNT-A)-assisted rehabilitation on spasticity, gait, and motivation in children with hemiplegic cerebral palsy.
A total of 81 patients with hemiplegic cerebral palsy who had received botulinum toxin type A (BoNT-A) injections to selected lower extremity muscles within the previous week were initially evaluated. After applying the inclusion and exclusion criteria, 43 participants were enrolled in the study, and 38 patients were excluded. All botulinum toxin injections were performed using onabotulinumtoxinA by an experienced physiatrist with more than five years of clinical experience. Injection planning was individualized according to body weight, severity of spasticity, and targeted muscle groups.
Participants were randomly assigned in a 1:1 ratio to two groups (22 in the intervention group and 21 in the control group). Randomization was performed using a computer-generated random sequence by an independent researcher who was not involved in treatment or assessment. Allocation concealment was ensured using sequentially numbered, opaque, sealed envelopes. The study was conducted as a single-blind trial in which the outcome assessors were blinded to group allocation, while participants and therapists were not blinded because of the nature of the intervention.
Both groups received a conventional rehabilitation program for 4 weeks, 5 days per week, 1 hour per day. The program included range of motion (ROM) exercises for the upper and lower extremities, stretching and strengthening exercises, balance and coordination training, endurance exercises, and ambulation training, all delivered under physiotherapist supervision according to a standardized protocol.
In addition to conventional rehabilitation, the intervention group received whirlpool therapy three times per week for 4 weeks, with each session lasting 20 minutes, for a total of 12 sessions. All whirlpool therapy sessions were conducted under physiotherapist supervision.
Outcome measures were assessed at three time points: baseline (T0, week 0, pre-treatment), post-treatment (T1, week 4), and follow-up (T2, week 12). Spasticity was evaluated using the Modified Ashworth Scale (MAS) and the Modified Tardieu Scale (MTS). Functional mobility and standing/walking abilities were assessed using the Gross Motor Function Measure-88 (GMFM-88) dimensions D and E. Motivation was evaluated using the Pediatric Motivation Scale. Gait kinematics, including joint range of motion and peak flexion and extension angles of the hip, knee, and ankle, were analyzed using the DIERS 4D Motion Lab system. Functional walking performance was assessed using the 10-Meter Walk Test (10MWT).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a two-arm, parallel-group randomized controlled trial. Participants with hemiplegic cerebral palsy who received recent botulinum toxin-A injections were allocated in a 1:1 ratio to either a conventional physiotherapy group or a conventional physiotherapy plus whirlpool therapy group. The study evaluates the additional effect of whirlpool therapy on rehabilitation outcomes.
| Arm | Type | Receives |
|---|---|---|
| Botulinum Toxin + Conventional Physiotherapy + Whirlpool Therapy | Experimental | Behavioral: Conventional Rehabilitation, Other: Whirlpool TherapyPatients receiving 4 weeks of conventional physical therapy combined with whirlpool therapy (20 minutes per session, 3 times per week). |
| Botulinum Toxin + Conventional Physiotherapy | Active comparator | Behavioral: Conventional RehabilitationPatients receiving 4 weeks of conventional physical therapy alone. |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Diagnosis of hemiplegic cerebral palsy
- Age between 3 and 10 years
- Gross Motor Function Classification System (GMFCS) levels I-II
- Sufficient cognitive level to follow instructions
- Ability to walk at least 10 meters with an orthosis and/or walking aid
Key exclusion criteria (8 listed)
- Uncontrolled epilepsy
- Urinary incontinence
- Presence of lower extremity contractures
- History of previous orthopedic surgery
- Presence of hip subluxation
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 RehabilitationStandard rehabilitation program including range of motion exercises, stretching, strengthening, balance, coordination, endurance, and gait training, 5 days per week for 4 weeks under physiotherapist supervision. | Behavioural | Botulinum Toxin + Conventional Physiotherapy, Botulinum Toxin + Conventional Physiotherapy + Whirlpool Therapy |
| Whirlpool TherapyWhirlpool therapy administered 3 times per week for 4 weeks, 20 minutes per session (total 12 sessions), in addition to conventional rehabilitation. | Other | Botulinum Toxin + Conventional Physiotherapy + Whirlpool Therapy |
Primary outcome
Gross Motor Function Measure-88 (GMFM-88) - Dimension E (Walking, Running and Jumping)
Time frame: Baseline (Week 0), Week 4 (post-treatment), Week 12 (follow-up)
The primary outcome measure was the Gross Motor Function Measure-88 (GMFM-88) Dimension E, which evaluates walking, running, and jumping abilities in children with hemiplegic cerebral palsy. Each item is scored on a 4-point scale (0-3), and raw scores are converted to percentage values (0-100). Dimension E consists of 24 items, with a maximum raw score of 72 points.
6 secondary outcomes
Modified Ashworth Scale (MAS)
Time frame: Week 0, Week 4, Week 12
Pediatric Motivation Scale
Time frame: Week 4, Week 12
DIERS 4D Motion Analysis System
Time frame: Baseline (Week 0), Week 4, Week 12
10-Meter Walk Test (10MWT)
Time frame: Baseline (Week 0), Week 4, Week 12
Gross Motor Function Measure-88 (GMFM-88) - Dimension D (Standing)
Time frame: Baseline (Week 0), Week 4, Week 12
Modified Tardieu Scale (MTS)
Time frame: Week 0, Week 4, Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- 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.
DAMLA CANKURTARAN, MD principal investigator
Ankara Etlik City Hospital
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 Whirlpool Therapy in people with Cerebral Palsy (CP) and Cerebral Palsy, Hemiplegic, run by Ankara Etlik City Hospital 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 7 inclusion and 8 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: finished, as of the sponsor's last update on 8 Jul 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Gross Motor Function Measure-88 (GMFM-88) - Dimension E (Walking, Running and Jumping) (time frame: Baseline (Week 0), Week 4 (post-treatment), Week 12 (follow-up)). 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 8 Jul 2026.