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

NCT07690722 | Completed

• 1 other identifier: AEŞH-EK1-2025-046
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cerebral Palsy (CP); Cerebral Palsy, Hemiplegic

Keywords

Cerebral Palsy; Hemiplegic Cerebral Palsy; Botulinum Toxin A; Spasticity; Whirlpool Therapy; Hydrotherapy; Gait Analysis; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Modified Ashworth Scale (MAS)

  Week 0, Week 4, Week 12

• Pediatric Motivation Scale

  Week 4, Week 12

• DIERS 4D Motion Analysis System

  Baseline (Week 0), Week 4, Week 12

• 10-Meter Walk Test (10MWT)

  Baseline (Week 0), Week 4, Week 12

• Gross Motor Function Measure-88 (GMFM-88) - Dimension D (Standing)

  Baseline (Week 0), Week 4, Week 12

Study Arms (2)

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).

Behavioral: Conventional Rehabilitation; Other: Whirlpool Therapy

Botulinum Toxin + Conventional Physiotherapy

ACTIVE COMPARATOR

Patients receiving 4 weeks of conventional physical therapy alone.

Behavioral: Conventional Rehabilitation

Interventions

Conventional Rehabilitation BEHAVIORAL

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.

Botulinum Toxin + Conventional Physiotherapy; Botulinum Toxin + Conventional Physiotherapy + Whirlpool Therapy

Whirlpool Therapy OTHER

Whirlpool therapy administered 3 times per week for 4 weeks, 20 minutes per session (total 12 sessions), in addition to conventional rehabilitation.

Botulinum Toxin + Conventional Physiotherapy + Whirlpool Therapy

Eligibility Criteria

• Age: 3 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara Etlik City Hospital: lead

Study Sites (1)

Ankara Etlik City Hospital

Ankara, Ankara, 06010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy; Muscle Spasticity

Interventions

Hydrotherapy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Therapy Modalities; Therapeutics; Rehabilitation

Study Officials

• DAMLA CANKURTARAN, MD

  Ankara Etlik City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors were blinded to group allocation. Participants and physiotherapists were not blinded due to the nature of the intervention. Group assignments were concealed from evaluators during all assessments and data analyses were performed using coded group labels.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician

Model Details: 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.

Study Record Dates

• First Submitted: June 13, 2026
• First Posted: July 8, 2026
• Study Start: February 1, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 31, 2026
• Last Updated: July 8, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)