Cerebral Palsy
Conditions
Keywords
Spastic Hemiparetic Cerebral Palsy, Robot-Assisted Gait Training, Hydrotherapy, Conventional Physiotherapy, Pediatric Rehabilitation
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.
Interventions
BEHAVIORALRobot-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.
BEHAVIORALHydrotherapy
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.
BEHAVIORALConventional 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.
Sponsors
Kayseri University
Istanbul Arel University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
5 Years to 15 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Turkey (Türkiye)
Contacts
Primary ContactÖzge Baykan Çopuroğlu, Asst. Prof.
Outcome results
None listed