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

Istanbul Arel University

Status: Not yet enrolling

Conditions: Cerebral Palsy

Treatments: Behavioral: Robot-assisted gait training using Lokomat; Behavioral: Hydrotherapy; Behavioral: Conventional Physiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07031609

KayseriUniversity

Details and patient eligibility

About

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.

Enrollment: 45 estimated patients

Sex: All

Ages: 5 to 15 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 3 patient groups

Robot-Assisted Gait Training Group

Experimental group

Description:

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.

Treatment:

Behavioral: Robot-assisted gait training using Lokomat

Hydrotherapy Group

Experimental group

Description:

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.

Treatment:

Behavioral: Hydrotherapy

Conventional Physiotherapy Group

Experimental group

Description:

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.

Treatment:

Behavioral: Conventional Physiotherapy