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Not yet recruiting NCT07031609

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

No phase Interventional Cerebral Palsy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Robot-assisted gait training using Lokomat, Hydrotherapy, Conventional Physiotherapy.
Who it may be relevant to
Registry conditions: Cerebral Palsy. Basic parameters: 5 years — 15 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official 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

Overview

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.

Interventions

  • Behavioral Robot-assisted gait training using Lokomat
    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.
  • Behavioral Hydrotherapy
    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.
  • Behavioral Conventional Physiotherapy
    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.

Primary outcome measures

  • Muscle Strength [Time frame: Baseline and Week 6]
  • Balance [Time frame: Baseline and Week 6]
  • Functional Mobility [Time frame: Baseline and Week 6]
Secondary outcome measures (2)
  • Psychological Adjustment [Time frame: Baseline and Week 6]
  • Treatment Tolerance and Adherence [Time frame: Ongoing through 6 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Kayseri University — Kayseri

Publications

  • Graham HK, Rosenbaum P, Paneth N, Dan B, Lin JP, Damiano DL, Becher JG, Gaebler-Spira D, Colver A, Reddihough DS, Crompton KE, Lieber RL. Cerebral palsy. Nat Rev Dis Primers. 2016 Jan 7;2:15082. doi: 10.1038/nrdp.2015.82. PMID 27188686

Identifiers

NCT: NCT07031609 · KayseriUniversity

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗