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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-15
SponsorIstanbul Arel University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

  • 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.

Treatment groups

45 Participants
are divided into 3 treatment groups
Group A: Robot-Assisted Gait Training GroupExperimental treatment 1 intervention
Group B: Hydrotherapy GroupExperimental treatment 1 intervention
Group C: Conventional Physiotherapy GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Muscle Strength

Change in lower extremity muscle strength measured by hand-held dynamometer (MicroFET® 2) at baseline and after 6 weeks of intervention.

Time frame
Baseline and Week 6
2

Balance

Change in balance performance assessed by Pediatric Balance Scale (PBS).

Time frame
Baseline and Week 6
3

Functional Mobility

Change in mobility measured using the Timed Up and Go (TUG) test.

Time frame
Baseline and Week 6

Secondary outcomes

1

Psychological Adjustment

Change in psychosocial adjustment scores based on the Hacettepe Psychological Adjustment Scale for Children (parent-rated).

Time frame
Baseline and Week 6
2

Treatment Tolerance and Adherence

Number of completed sessions out of 12 scheduled sessions during the 6-week intervention period.

Time frame
Ongoing through 6 weeks

Other outcomes

Sponsors and contacts

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Istanbul Arel University

Lead sponsor

Kayseri University

Collaborator

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