Cerebral PalsyNCT07031609
Effects of Robotic Gait, Hydrotherapy, and Conventional Physiotherapy in Spastic Hemiparetic CP
A study testing Robot-assisted gait training using Lokomat, Hydrotherapy and Conventional Physiotherapy in people with Cerebral Palsy, run by Istanbul Arel University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Robot-assisted gait training using Lokomat, Hydrotherapy and Conventional Physiotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2025to 15 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Spastik Hemiparetik Serebral Palsili Bireylerde Robotik Destekli Yürüyüş Eğitimi, Hidroterapi ve Konvansiyoel Fizyoterapi Yöntemlerinin Kas Kuvveti, Denge, Fonksiyonel Mobilite ve Ruhsal Uyum Üzerindeki Etkileri
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
- Being tested
- Robot-assisted gait training using Lokomat, Hydrotherapy, Conventional Physiotherapy
- Keywords
- Spastic Hemiparetic Cerebral Palsy, Robot-Assisted Gait Training, Hydrotherapy, Conventional Physiotherapy, Pediatric Rehabilitation
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot-assisted gait training using LokomatBehavioural
Also called 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.
HydrotherapyBehavioural
Also called 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 PhysiotherapyBehavioural
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Conventional Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Strength
Change in lower extremity muscle strength measured by hand-held dynamometer (MicroFET® 2) at baseline and after 6 weeks of intervention.
Measured: Baseline and Week 6
Balance
Change in balance performance assessed by Pediatric Balance Scale (PBS).
Measured: Baseline and Week 6
Functional Mobility
Change in mobility measured using the Timed Up and Go (TUG) test.
Measured: Baseline and Week 6
Secondary outcomes (2)
Psychological Adjustment
Change in psychosocial adjustment scores based on the Hacettepe Psychological Adjustment Scale for Children (parent-rated).
Measured: Baseline and Week 6
Treatment Tolerance and Adherence
Number of completed sessions out of 12 scheduled sessions during the 6-week intervention period.
Measured: Ongoing through 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start15 Jul 2025 (estimated)
- Primary completion15 Jan 2026 (estimated)
- Study completion15 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Arel University
- Sponsor type
- University, hospital or other
- Collaborators
- Kayseri University
- Responsible party
- Principal investigator, Ozge Baykan Copuroglu, Istanbul Arel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07031609
- Sponsor's protocol ID
- KayseriUniversity
- Status last verified
- Jun 2025
- First submitted
- 13 Jun 2025
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 27188686
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spastik Hemiparetik Serebral Palsili Bireylerde Robotik Destekli Yürüyüş Eğitimi, Hidroterapi ve Konvansiyoel Fizyoterapi Yöntemlerinin Kas Kuvveti, Denge, Fonksiyonel Mobilite ve Ruhsal Uyum Üzerindeki Etkileri
- ClinicalTrials.gov ID
- NCT07031609
- Acronym / sponsor ID
- KayseriUniversity
- Conditions
- Cerebral Palsy
- Keywords
- Spastic Hemiparetic Cerebral Palsy, Robot-Assisted Gait Training, Hydrotherapy, Conventional Physiotherapy, Pediatric Rehabilitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Istanbul Arel UniversityUniversity, hospital or other
- Collaborators
- Kayseri University
- Study start
- 15 Jul 2025 (estimated)
- Primary completion
- 15 Jan 2026 (estimated)
- Study completion
- 15 Jul 2026 (estimated)
- First posted
- 22 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Robot-Assisted Gait Training Group | Experimental | Behavioral: Robot-assisted gait training using LokomatParticipants 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: HydrotherapyParticipants 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 PhysiotherapyThis 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. |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robot-assisted gait training using LokomatAlso: Lokomat-based gait rehabilitationThis 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. | Behavioural | Robot-Assisted Gait Training Group |
| HydrotherapyAlso: Aquatic exercise program, Water-based physiotherapyParticipants 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. | Behavioural | Hydrotherapy Group |
| Conventional PhysiotherapyAlso: Standard conventional physiotherapy, Traditional physiotherapyThis 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. | Behavioural | Conventional Physiotherapy Group |
Primary outcome
Muscle Strength
Time frame: 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
Time frame: Baseline and Week 6
Change in balance performance assessed by Pediatric Balance Scale (PBS).
Functional Mobility
Time frame: Baseline and Week 6
Change in mobility measured using the Timed Up and Go (TUG) test.
2 secondary outcomes
Psychological Adjustment
Time frame: Baseline and Week 6
Treatment Tolerance and Adherence
Time frame: Ongoing through 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2025.
- Background: PubMed 27188686Graham 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robot-assisted gait training using Lokomat, Hydrotherapy and Conventional Physiotherapy in people with Cerebral Palsy, run by Istanbul Arel University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Özge Baykan Çopuroğlu, Asst. Prof. (+905544562877, ozgebaykancopuroglu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle Strength (time frame: Baseline and Week 6). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07031609, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2025.