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

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: Cerebral Palsy
• Intervention / Treatment: Behavioral: Robot-assisted gait training using Lokomat; Behavioral: Hydrotherapy; Behavioral: Conventional Physiotherapy

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Özge Baykan Çopuroğlu, Asst. Prof.; Phone Number: +905544562877; Email: ozgebaykancopuroglu@gmail.com

Study Locations

• Turkey
  • Kayseri, Turkey, 38130
    • Kayseri University

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

3

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	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	Change in balance performance assessed by Pediatric Balance Scale (PBS).	Baseline and Week 6
Functional Mobility	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	Change in psychosocial adjustment scores based on the Hacettepe Psychological Adjustment Scale for Children (parent-rated).	Baseline and Week 6
Treatment Tolerance and Adherence	Number of completed sessions out of 12 scheduled sessions during the 6-week intervention period.	Ongoing through 6 weeks

Collaborators and Investigators

• Sponsor: Istanbul Arel University
• Collaborators: Kayseri University

Publications and helpful links

General 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.

Study record dates

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: Robot-Assisted Gait Training; Hydrotherapy; Conventional Physiotherapy; Spastic Hemiparetic Cerebral Palsy; Pediatric Rehabilitation
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• 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