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NCT Number: NCT07031609

Effects of Robotic Gait, Hydrotherapy, and Conventional Physiotherapy in Spastic Hemiparetic CP

This study aims to evaluate the effects of three different physiotherapy approaches-robot-assisted gait training, hydrotherapy, and conventional physiotherapy-on muscle strength, balance, functional mobility, and psychological adjustment in children diagnosed with spastic hemiparetic cerebral palsy. A total of 45 ambulatory children aged 5 to 15 years will be randomly assigned to one of the three intervention groups. All participants will receive therapy twice a week for six weeks.

Muscle strength will be assessed using a handheld dynamometer, balance with the Pediatric Balance Scale, mobility with the Timed Up and Go test, and psychological adjustment with a standardized behavioral checklist. The study will help determine which therapeutic approach provides the most benefit in improving physical function and emotional well-being. Results may guide healthcare providers and families in selecting the most effective rehabilitation method for children with cerebral palsy.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

5 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kayseri University

Kayseri, 38130, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children aged between 5 and 15 years
  • Diagnosed with spastic hemiparetic cerebral palsy
  • Classified as Level I or II on the Gross Motor Function Classification System (GMFCS)
  • Able to follow simple instructions and participate in therapy sessions
  • Written informed consent obtained from parents or legal guardians

Exclusion criteria

  • Severe cognitive or mental impairment that interferes with communication
  • Lower extremity joint contractures preventing use of robotic gait device
  • Uncontrolled cardiac disease
  • Active infection at the time of intervention
  • Open skin lesions on the legs or trunk
  • Inability to properly fit orthoses required for therapy
  • Withdrawal of consent by the child or parent/guardian
  • Failure to complete the assessment tests
  • New illness or surgical intervention during the study period

Treatment and study plan

Robot-assisted gait training using Lokomat

Behavioral

This intervention involves robotic-assisted gait training with the Lokomat device. Sessions will last 40 minutes, twice a week for 6 weeks. The intervention targets lower extremity motor function in children with spastic hemiparetic cerebral palsy. The robotic system provides adjustable support and real-time feedback to improve gait patterns and mobility.

Other names: Lokomat-based gait rehabilitation

Hydrotherapy

Behavioral

Participants will engage in supervised aquatic therapy including structured exercises in a therapeutic pool. Each session lasts 40 minutes, twice a week, for 6 weeks. Exercises include water walking, floating resistance training, jumping, and balance activities designed for children with spastic hemiparetic cerebral palsy to improve strength, coordination, and functional mobility.

Other names: Aquatic exercise program, Water-based physiotherapy

Conventional Physiotherapy

Behavioral

This intervention includes 20 minutes of faradic electrical stimulation and 20 minutes of therapeutic exercises such as stretching, positioning, range of motion, and gait training. Administered twice a week for 6 weeks. The protocol aims to support neuromuscular activation and improve gait and mobility in children with spastic hemiparetic cerebral palsy.

Other names: Standard conventional physiotherapy, Traditional physiotherapy

Primary outcomes

  1. Muscle Strength

    Time frame: Baseline and Week 6

    Change in lower extremity muscle strength measured by hand-held dynamometer (MicroFET® 2) at baseline and after 6 weeks of intervention.

  2. Balance

    Time frame: Baseline and Week 6

    Change in balance performance assessed by Pediatric Balance Scale (PBS).

  3. Functional Mobility

    Time frame: Baseline and Week 6

    Change in mobility measured using the Timed Up and Go (TUG) test.

Secondary outcomes

  1. Psychological Adjustment

    Time frame: Baseline and Week 6

    Change in psychosocial adjustment scores based on the Hacettepe Psychological Adjustment Scale for Children (parent-rated).

  2. Treatment Tolerance and Adherence

    Time frame: Ongoing through 6 weeks

    Number of completed sessions out of 12 scheduled sessions during the 6-week intervention period.

Study contacts

Contact information is provided by the study sponsor or research team.

Özge Baykan Çopuroğlu, Asst. Prof.

CONTACT

[email protected]

+905544562877

Sponsors and collaborators

Lead sponsor

Istanbul Arel University

Other

Collaborators

  • Kayseri University

Registry information

Official study title

Spastik Hemiparetik Serebral Palsili Bireylerde Robotik Destekli Yürüyüş Eğitimi, Hidroterapi ve Konvansiyoel Fizyoterapi Yöntemlerinin Kas Kuvveti, Denge, Fonksiyonel Mobilite ve Ruhsal Uyum Üzerindeki Etkileri

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 22, 2025
Registry last updated
Jun 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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