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

NCT07031609 | Not Yet Recruiting

• 1 other identifier: KayseriUniversity
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

Keywords

Spastic Hemiparetic Cerebral Palsy; Robot-Assisted Gait Training; Hydrotherapy; Conventional Physiotherapy; Pediatric Rehabilitation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Psychological Adjustment

  Baseline and Week 6

• Treatment Tolerance and Adherence

  Ongoing through 6 weeks

Study Arms (3)

Robot-Assisted Gait Training Group

EXPERIMENTAL

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

Hydrotherapy Group

EXPERIMENTAL

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

Conventional Physiotherapy Group

EXPERIMENTAL

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

Interventions

Robot-assisted gait training using Lokomat 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.

Also known as: Lokomat-based gait rehabilitation

Robot-Assisted Gait Training Group

Hydrotherapy 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.

Also known as: Aquatic exercise program, Water-based physiotherapy

Hydrotherapy Group

Conventional Physiotherapy 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.

Also known as: Standard conventional physiotherapy, Traditional physiotherapy

Conventional Physiotherapy Group

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Arel University: lead
• Kayseri University: collaborator

Study Sites (1)

Kayseri University

Kayseri, Kayseri, 38130, Turkey (Türkiye)

Location

Related Publications (1)

• 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 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Hydrotherapy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Physical Therapy Modalities; Therapeutics; Rehabilitation

Central Study Contacts

Özge Baykan Çopuroğlu, Asst. Prof.

CONTACT

+905544562877; ozgebaykancopuroglu@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking will be implemented in this study. All participants, care providers, investigators, and outcome assessors will be aware of the assigned interventions due to the nature of the treatment protocols.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof.

Model Details: This is a randomized controlled trial with a parallel assignment model. Participants will be randomly allocated into three parallel intervention groups: (1) robot-assisted gait training, (2) hydrotherapy, and (3) conventional physiotherapy. Each group will receive two sessions per week for six weeks. The interventions will be administered independently, with no crossover between groups. Outcome measures will be assessed at baseline and after the six-week intervention period.

Study Record Dates

• First Submitted: June 13, 2025
• First Posted: June 22, 2025
• Study Start: July 15, 2025
• Primary Completion: January 15, 2026
• Study Completion (Estimated): July 15, 2026
• Last Updated: June 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)