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

NCT07031609 — Not applicable, Not yet recruiting, 45 participants, Istanbul Arel University

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

Registry	NCT07031609
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	45 (Estimated)
Sponsor	Istanbul Arel University (Other); collaborators: Kayseri University
Conditions	Cerebral Palsy
Interventions	Robot-assisted gait training using Lokomat, Hydrotherapy, Conventional Physiotherapy (Behavioral)
Dates	start 2025-07-15 (estimated), primary completion 2026-01-15 (estimated), completion 2026-07-15 (estimated), first posted 2025-06-22, last updated 2025-06-22
Locations	1 site in Turkey (Türkiye)

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Robot-Assisted Gait Training Group	Experimental	Behavioral: Robot-assisted gait training using Lokomat	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.
Hydrotherapy Group	Experimental	Behavioral: Hydrotherapy	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.
Conventional Physiotherapy Group	Experimental	Behavioral: Conventional Physiotherapy	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.

Robot-assisted gait training using Lokomat (Behavioral), also known as Lokomat-based gait rehabilitation: 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 (Behavioral), also known as Aquatic exercise program, Water-based physiotherapy: 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 (Behavioral), also known as Standard conventional physiotherapy, Traditional 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.

+Outcome measures

Primary outcomes

Muscle Strength [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.
Balance [Baseline and Week 6]: Change in balance performance assessed by Pediatric Balance Scale (PBS).
Functional Mobility [Baseline and Week 6]: Change in mobility measured using the Timed Up and Go (TUG) test.

Secondary outcomes

Psychological Adjustment [Baseline and Week 6]: Change in psychosocial adjustment scores based on the Hacettepe Psychological Adjustment Scale for Children (parent-rated).
Treatment Tolerance and Adherence [Ongoing through 6 weeks]: Number of completed sessions out of 12 scheduled sessions during the 6-week intervention period.

+Eligibility

Sex: All, ages: 5 Years to 15 Years

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

+Locations (1)

Facility	City	Country	Status
Kayseri University	Kayseri, Kayseri	Turkey (Türkiye)

+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. PMID 27188686