Effect of Whirlpool Therapy Combined With Botulinum Toxin in Children With Cerebral Palsy

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy (CP); Cerebral Palsy, Hemiplegic
• Intervention / Treatment: Behavioral: Conventional Rehabilitation; Other: Whirlpool Therapy

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 Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Ankara
    • Ankara, Ankara, Turkey (Türkiye), 06010
      • Ankara Etlik City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Botulinum Toxin + Conventional Physiotherapy + Whirlpool Therapy; Patients receiving 4 weeks of conventional physical therapy combined with whirlpool therapy (20 minutes per session, 3 times per week).	Behavioral: Conventional Rehabilitation; 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.; Other: Whirlpool Therapy; Whirlpool therapy administered 3 times per week for 4 weeks, 20 minutes per session (total 12 sessions), in addition to conventional rehabilitation.
Active Comparator: Botulinum Toxin + Conventional Physiotherapy; Patients receiving 4 weeks of conventional physical therapy alone.	Behavioral: Conventional Rehabilitation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline (Week 0), Week 4 (post-treatment), Week 12 (follow-up)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	Week 0, Week 4, Week 12

Collaborators and Investigators

• Sponsor: Ankara Etlik City Hospital
• Investigators: Principal Investigator: DAMLA CANKURTARAN, MD, Ankara Etlik City Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2025
• Primary Completion (Actual): May 1, 2026
• Study Completion (Actual): May 31, 2026

Study Registration Dates

• First Submitted: June 13, 2026
• First Submitted That Met QC Criteria: July 6, 2026
• First Posted (Actual): July 8, 2026

Study Record Updates

• Last Update Posted (Actual): July 8, 2026
• Last Update Submitted That Met QC Criteria: July 6, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Rehabilitation; Cerebral Palsy; Botulinum Toxin A; Spasticity; Gait Analysis; Hemiplegic Cerebral Palsy; Hydrotherapy; Whirlpool Therapy
• Additional Relevant MeSH Terms: Neurologic Manifestations; Musculoskeletal Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Muscular Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Brain Damage, Chronic; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Muscle Spasticity; Cerebral Palsy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Hydrotherapy
• Other Study ID Numbers: AEŞH-EK1-2025-046

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