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

NCT ID: NCT07031609

Last Updated: 2025-06-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-15
• Study Completion Date: 2026-07-15

Brief Summary

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.

Conditions

Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Robot-assisted gait training using Lokomat

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Hydrotherapy

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Conventional Physiotherapy

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Lokomat-based gait rehabilitation; Aquatic exercise program; Water-based physiotherapy; Standard conventional physiotherapy; Traditional physiotherapy

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kayseri University

OTHER

Sponsor Role: collaborator

Istanbul Arel University

OTHER

Sponsor Role: lead

Responsible Party

Ozge Baykan Copuroglu

Asst. Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kayseri University

Kayseri, Kayseri, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Özge Baykan Çopuroğlu, Asst. Prof.

Role: CONTACT

ozgebaykancopuroglu@gmail.com

+905544562877

References

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.

Reference Type: BACKGROUND

PMID: 27188686 (View on PubMed)

Other Identifiers

KayseriUniversity

Identifier Type: -

Identifier Source: org_study_id