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

June 13, 2025 updated by: Ozge Baykan Copuroglu, Istanbul Arel University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Kayseri, Turkey, 38130
        • Kayseri University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Robot-Assisted Gait Training Group
Participants in this arm will receive robot-assisted gait training using the Lokomat device for 40 minutes, twice a week, over a 6-week period. The intervention aims to improve lower limb muscle strength, balance, and mobility.
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.
Other Names:
  • Lokomat-based gait rehabilitation
Experimental: Hydrotherapy Group
Participants will undergo supervised aquatic exercises in a therapeutic pool for 40 minutes, twice a week, for 6 weeks. The exercises are designed to enhance strength, coordination, and balance in children with spastic hemiparetic cerebral palsy.
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.
Other Names:
  • Aquatic exercise program
  • Water-based physiotherapy
Experimental: Conventional Physiotherapy Group
This group will receive conventional physiotherapy consisting of electrotherapy (faradic stimulation), passive and active range of motion exercises, gait training, and positioning techniques. Sessions last 40 minutes, twice a week, for 6 weeks.
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.
Other Names:
  • Traditional physiotherapy
  • Standard conventional physiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and Week 6
Balance
Time Frame: Baseline and Week 6
Change in balance performance assessed by Pediatric Balance Scale (PBS).
Baseline and Week 6
Functional Mobility
Time Frame: Baseline and Week 6
Change in mobility measured using the Timed Up and Go (TUG) test.
Baseline and Week 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psychological Adjustment
Time Frame: Baseline and Week 6
Change in psychosocial adjustment scores based on the Hacettepe Psychological Adjustment Scale for Children (parent-rated).
Baseline and Week 6
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.
Ongoing through 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Arel University

Collaborators

Kayseri University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 15, 2025

Primary Completion (Estimated)

January 15, 2026

Study Completion (Estimated)

July 15, 2026

Study Registration Dates

First Submitted

June 13, 2025

First Submitted That Met QC Criteria

June 13, 2025

First Posted (Actual)

June 22, 2025

Study Record Updates

Last Update Posted (Actual)

June 22, 2025

Last Update Submitted That Met QC Criteria

June 13, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KayseriUniversity

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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