Neurodevelopmental DisordersRAGTNEUDEVNCT06645795
Robot Asissted Training on Neurodevelopmental Alterations
A study testing Robot assisted gait training plus conventional physical therapy and Conventional pjysical therapy in people with Neurodevelopmental Disorders and Cerebral Palsy, run by University of Valencia at 1 site in Spain.
Trial summary
The aim of this randomized crossover clinical trial is to determine the effect of robot assisted gait training combined with physiotherapy on body composition and functional variables in a pediatric population with neurodevelopmental disorders.The main questions to answer are: Does this treatment improve body… Read more about this study
- Who is it for?
- Ages 1 year to 16 years
- Conditions the study is for
- Neurodevelopmental Disorders, Cerebral Palsy
- What is being tested?
- Robot assisted gait training plus conventional physical therapy and Conventional pjysical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteSpain
- Study dates
- 17 Oct 2024to 15 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 1 year to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediactric population with neurodevelopmental disorders who have been diagnosed with cerebral palsy.
- With a level IV or V of the GMFCS.
- Adapted to the school environment (> 6 months).
- Unable to stand without support.
- Receiving conventional physiotherapy (> 6 months).
- Receiving a standing program (standing duration at school: at least 45 minutes/day).
- With ankle orthosis.
- Meeting the specific criteria of the exoskeleton manufacturer (ATLAS 2030 Marsibionics https://www.marsibionics.com/): Weight less than 35 kg, Hip width less than 35 cm, Distance from the center of rotation of the hip to that of the knee between 24 and 33 cm, distance from the center of rotation of the knee to that of the ankle between 23 and 32 cm, the ankle can reach close to 90º with or without an orthosis, shoe size less than 33, hip and knee flexion less than or equal to 20º (even after having previously warmed up).
Who cannot join
- Severe spinal deformity.
- Severe hip dysplasia.
- Knee and hip flexion greater than 20º.
- Children treated surgically within the 1-year period prior to the evaluation date.
- Skin inflammation and open skin lesions around the trunk or limbs.
- Uncontrolled epilepsy: active epilepsy resistant to medication.
- Pacemaker, defibrillator or osteosynthesis material carriers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Physiotherapy Based on Robot Assited Gait Training on Body Composition and Functional Variables in Pediatric Patient With Neurodevelopmental Alterations: Randomized and Crossover Clinical Trial
The aim of this randomized crossover clinical trial is to determine the effect of robot assisted gait training combined with physiotherapy on body composition and functional variables in a pediatric population with neurodevelopmental disorders.The main questions to answer are:
- Does this treatment improve body composition parameters?
- Does the treatment help maintaining functionality and without causing discomfort or pain?
Participants will perform 2 weekly physiotherapy sessions for 8 weeks, then there will be 4 weeks of washout, afer which each patient will cross over to the other group for 8 more weeks.
Read the detailed description
Pediatric population with neurodevelopmental disorders, such as cerebral palsy (CP), levels IV-V of the Gross Motor Function Classification System (GMFCS), do not walk independently due to their significant physical limitations, so their body composition may be altered, which in turn affects their functional level and may lead to the appearance of musculoskeletal complications. Robot assisted gait training (RAGT) offers a new opportunity to improve mobility of pediatric population with CP levels IV-V of GMFCS, although scientific literature is still scarce in this population.
The main aim of this study is to determine the effect of RAGT on body composition and functional variables in a pediatric population with neurodevelopmental disorders. Also to analyze changes in functional, musculoeskeletal, and stress biomarkers variables after the intervention, and to evaluate the cardiorespiratory adaptation to the RAGT.
A convenience sample of 10-12 participants will be selected, who will serve as their own control. It has been taken into account that previous studies conducted on pediatric population with CP this sample size is adequate.
At the beginning of the study, 50% of the participants will be part of the RAGT group, which will perform 2 weekly sessions of RAGT plus conventional therapy; and the other 50% will belong to the conventional physical therapy group. The study consists of phases 1 and 2 of treatment with a washout period between phases: after "phase 1" (8 weeks of therapy in one of the two groups), there will be 4 weeks of washout, after which each patient will cross over to the other group in "phase 2" (for 8 weeks).
Participants will be assessed before phase 1 (T1), after phase 1 (T2), before phase 2 (T3) and after phase 2 (T4).
- Conditions
- Neurodevelopmental Disorders, Cerebral Palsy
- Being tested
- Robot assisted gait training plus conventional physical therapy, Conventional pjysical therapy
- Keywords
- cerebral palsy, neurodevelopmental disorders, robot assisted gait training, physical therapy, body composition, musculoeskeletal
- Medical subject headings
- Neurodevelopmental Disorders, 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 plus conventional physical therapyCombination product
Participants will complete 8 weeks of intervention of robot assisted gait training with the ATLAS 2030 exoskeleton (Marsi Bionics) owned by the school which they attend to. They will have 2 weekly sessions (16 sessions in total) for 4 weeks. Each session will last up to 1 hour (depending on the child's tolerance) although a minimum of 30 minutes per session and a minimum of 12 sessions will be set in this time. The training mode will be automatic. In addition, they will continue to carry out the rest of their usual treatments.
Conventional pjysical therapyOther
Participants will complete 8 weeks of conventional therapy, with 2 sessions per week (16 sessions total). During the conventional treatment period, participants will continue with the conventional physical therapy they have received thus far. The content of the usual care treatment does not specifically address gait training, but consists of elements addressing range of motion, tone reduction, balance, activities of daily living, etc. The conventional intervention may be different for each individual based on their needs (to represent usual care), however, participants will be advised not to change the intervention, type, and frequency during the study.
| Study group | Role | What they receive |
|---|---|---|
| robot assisted gait training plus conventional physical therapy | Experimental | Participants will complete 8 weeks of intervention of robot assisted gait training plus conventional physical therapy. Receives: Combination Product: Robot assisted gait training plus conventional physical therapy |
| Conventional physical therapy | Active comparator | Participants will complete 8 weeks of conventional therapy. Receives: Other: Conventional pjysical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body composition, fat %
Measured by bioimpedanciometry (BIA): fat (%).
Measured: Before phase 1 (T1, pre intervention), after phase 1 (T2, after 8 weeks intervention), before phase 2 (T3, pre intervention) and after phase 2 (T4, after 8 weeks intervention).
Body composition, fat in kg
Measured by bioimpedanciometry (BIA): fat (kg)
Measured: Before phase 1 (T1, pre intervention), after phase 1 (T2, after 8 weeks intervention), before phase 2 (T3, pre intervention) and after phase 2 (T4, after 8 weeks intervention).
Body composition, lean mass (kg)
Measured by bioimpedanciometry (BIA): lean mass (kg), lean mass (%), total mass (%), dry lean weight (%), Body mass index, and resistance at 50 kHz measured in Ohms
Measured: Before phase 1 (T1, pre intervention), after phase 1 (T2, after 8 weeks intervention), before phase 2 (T3, pre intervention) and after phase 2 (T4, after 8 weeks intervention).
Body composition, lean mass (%)
Measured by bioimpedanciometry (BIA): lean mass (%).
Measured: Before phase 1 (T1, pre intervention), after phase 1 (T2, after 8 weeks intervention), before phase 2 (T3, pre intervention) and after phase 2 (T4, after 8 weeks intervention).
Body composition, dry lean weight
Measured by bioimpedanciometry (BIA): dry lean weight (%).
Measured: Before phase 1 (T1, pre intervention), after phase 1 (T2, after 8 weeks intervention), before phase 2 (T3, pre intervention) and after phase 2 (T4, after 8 weeks intervention).
Bone mineral density.
Measured by ultrasound densitometry.
Measured: Before phase 1 (T1, pre intervention), after phase 1 (T2, after 8 weeks intervention), before phase 2 (T3, pre intervention) and after phase 2 (T4, after 8 weeks intervention).
Secondary outcomes (14)
Functional and musculoeskeletal assessmement, clinical data.
Measured by the "Cerebral Palsy Follow-Up Program" (CPUP): clinical data.
Measured: Before phase 1 (T1, pre intervention), after phase 1 (T2, after 8 weeks intervention), before phase 2 (T3, pre intervention) and after phase 2 (T4, after 8 weeks intervention).
Functional and musculoeskeletal assessmement, musculoskeletal history.
Measured by the "Cerebral Palsy Follow-Up Program" (CPUP): musculoskeletal history (previous history of fractures, subluxation or hip dysplasia), technical aids that are currently needed, neurorehabilitation treatments that are currently received at the center.
Measured: Before phase 1 (T1, pre intervention), after phase 1 (T2, after 8 weeks intervention), before phase 2 (T3, pre intervention) and after phase 2 (T4, after 8 weeks intervention).
Functional and musculoeskeletal assessmement, disability assessment
Measured by the "Cerebral Palsy Follow-Up Program" (CPUP): disability assessment using the Pediatric Evaluation Disability Inventory (PEDI), range of motion of lower limb joints (it will be measured with a goniometer for hip, knee and ankle), spasticity in the muscles of the lower limbs (it will be measured with the modified Asworth Scale), and also the functional capacity using the Functional Mobility Scale (FMS).
Measured: Before phase 1 (T1, pre intervention), after phase 1 (T2, after 8 weeks intervention), before phase 2 (T3, pre intervention) and after phase 2 (T4, after 8 weeks intervention).
Functional and musculoeskeletal assessmement, range of motion
Measured by the "Cerebral Palsy Follow-Up Program" (CPUP): range of motion of lower limb joints (it will be measured with a goniometer for hip, knee and ankle), spasticity in the muscles of the lower limbs (it will be measured with the modified Asworth Scale), and also the functional capacity using the Functional Mobility Scale (FMS).
Measured: Before phase 1 (T1, pre intervention), after phase 1 (T2, after 8 weeks intervention), before phase 2 (T3, pre intervention) and after phase 2 (T4, after 8 weeks intervention).
Functional and musculoeskeletal assessmement, spasticity
Measured by the "Cerebral Palsy Follow-Up Program" (CPUP): spasticity in the muscles of the lower limbs (it will be measured with the modified Asworth Scale), and also the functional capacity using the Functional Mobility Scale (FMS).
Measured: Before phase 1 (T1, pre intervention), after phase 1 (T2, after 8 weeks intervention), before phase 2 (T3, pre intervention) and after phase 2 (T4, after 8 weeks intervention).
Functional and musculoeskeletal assessmement, functional capacity
Measured by the "Cerebral Palsy Follow-Up Program" (CPUP): functional capacity using the Functional Mobility Scale (FMS).
Measured: Before phase 1 (T1, pre intervention), after phase 1 (T2, after 8 weeks intervention), before phase 2 (T3, pre intervention) and after phase 2 (T4, after 8 weeks intervention).
Anthropometric measurements, weight
Weight (kg)
Measured: Before phase 1 (T1, pre intervention), after phase 1 (T2, after 8 weeks intervention), before phase 2 (T3, pre intervention) and after phase 2 (T4, after 8 weeks intervention).
Anthropometric measurements, height
Height (cm)
Measured: Before phase 1 (T1, pre intervention), after phase 1 (T2, after 8 weeks intervention), before phase 2 (T3, pre intervention) and after phase 2 (T4, after 8 weeks intervention).
Anthropometric measurements, BMI
Body Mass Index (kg/m2)
Measured: Before phase 1 (T1, pre intervention), after phase 1 (T2, after 8 weeks intervention), before phase 2 (T3, pre intervention) and after phase 2 (T4, after 8 weeks intervention).
Anthropometric measurements, circumferences
circumferences of arm, calf, waist and hip (cm)
Measured: Before phase 1 (T1, pre intervention), after phase 1 (T2, after 8 weeks intervention), before phase 2 (T3, pre intervention) and after phase 2 (T4, after 8 weeks intervention).
Nutritional status
The nutritional status of each participant will be defined by weight-for-age percentiles, height-for-age percentiles, weight-for-height ratio, and BMI-for-age, following WHO growth charts and ASPEN standards, as in previous studies in this population.
Measured: Before phase 1 (T1, pre intervention), after phase 1 (T2, after 8 weeks intervention), before phase 2 (T3, pre intervention) and after phase 2 (T4, after 8 weeks intervention).
Postural ability
Posture and Postural Ability Scale (PPAS) in sitting, supine and prone.
Measured: Before phase 1 (T1, pre intervention), after phase 1 (T2, after 8 weeks intervention), before phase 2 (T3, pre intervention) and after phase 2 (T4, after 8 weeks intervention).
Cardio-respiratory measurement, heart rate
Heart rate (HR) will be measured by pulse oximetry.
Measured: Before phase 1 (T1, pre intervention), after phase 1 (T2, after 8 weeks intervention), before phase 2 (T3, pre intervention) and after phase 2 (T4, after 8 weeks intervention).
Cardio-respiratory measurement, oxygen saturation
Oxygen saturation (SaO2) will be measured by pulse oximetry.
Measured: Before phase 1 (T1, pre intervention), after phase 1 (T2, after 8 weeks intervention), before phase 2 (T3, pre intervention) and after phase 2 (T4, after 8 weeks intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start17 Oct 2024
- Primary completion30 Jun 2026
- Study completion15 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Neurodevelopmental DisordersStudies 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
- Crossover
- Model description
- Randomized crossover clinical trial.
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Investigacion Sanitaria La Fe, CEE Cruz Roja Valencia
- Responsible party
- Principal investigator, Anna Arnal Gómez, University of Valencia
- Investigators
- ANNA ARNAL-GOMEZ, Dr., Principal investigator, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06645795
- Sponsor's protocol ID
- RAGT_NEUROVELOP
- Acronym
- RAGTNEUDEV
- Status last verified
- May 2026
- First submitted
- 4 Oct 2024
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Engsberg JR, Ross SA, Collins DR. Increasing ankle strength to improve gait and function in children with cerebral palsy: a pilot study. Pediatr Phys Ther. 2006 Winter;18(4):266-75. doi: 10.1097/01.pep.0000233023.33383.2b.
PubMed 17108800McCormick AM, Alazem H, Zaidi S, Barrowman NJ, Ward LM, McMillan HJ, Longmuir P, Larin M, Dalton K. A randomized, cross-over trial comparing the effect of innovative robotic gait training and functional clinical therapy in children with cerebral palsy; a protocol to test feasibility. Contemp Clin Trials. 2023 Apr;127:107086. doi: 10.1016/j.cct.2023.107086. Epub 2023 Jan 17.
PubMed 36669727Peungsuwan P, Parasin P, Siritaratiwat W, Prasertnu J, Yamauchi J. Effects of Combined Exercise Training on Functional Performance in Children With Cerebral Palsy: A Randomized-Controlled Study. Pediatr Phys Ther. 2017 Jan;29(1):39-46. doi: 10.1097/PEP.0000000000000338.
PubMed 27984466Zhao X, Chen M, Du S, Li H, Li X. Evaluation of stress and pain in young children with cerebral palsy during early developmental intervention programs: a descriptive study. Am J Phys Med Rehabil. 2015 Mar;94(3):169-75; quiz 176-9. doi: 10.1097/PHM.0000000000000252.
PubMed 25500686
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Physiotherapy Based on Robot Assited Gait Training on Body Composition and Functional Variables in Pediatric Patient With Neurodevelopmental Alterations: Randomized and Crossover Clinical Trial
- ClinicalTrials.gov ID
- NCT06645795
- Acronym / sponsor ID
- RAGTNEUDEV / RAGT_NEUROVELOP
- Conditions
- Neurodevelopmental Disorders, Cerebral Palsy
- Keywords
- cerebral palsy, neurodevelopmental disorders, robot assisted gait training, physical therapy, body composition, musculoeskeletal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Collaborators
- Instituto de Investigacion Sanitaria La Fe, CEE Cruz Roja Valencia
- Study start
- 17 Oct 2024 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 15 Oct 2026 (actual)
- First posted
- 17 Oct 2024 (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.
The aim of this randomized crossover clinical trial is to determine the effect of robot assisted gait training combined with physiotherapy on body composition and functional variables in a pediatric population with neurodevelopmental disorders.The main questions to answer are:
- Does this treatment improve body composition parameters?
- Does the treatment help maintaining functionality and without causing discomfort or pain?
Participants will perform 2 weekly physiotherapy sessions for 8 weeks, then there will be 4 weeks of washout, afer which each patient will cross over to the other group for 8 more weeks.
Detailed description
Pediatric population with neurodevelopmental disorders, such as cerebral palsy (CP), levels IV-V of the Gross Motor Function Classification System (GMFCS), do not walk independently due to their significant physical limitations, so their body composition may be altered, which in turn affects their functional level and may lead to the appearance of musculoskeletal complications. Robot assisted gait training (RAGT) offers a new opportunity to improve mobility of pediatric population with CP levels IV-V of GMFCS, although scientific literature is still scarce in this population.
The main aim of this study is to determine the effect of RAGT on body composition and functional variables in a pediatric population with neurodevelopmental disorders. Also to analyze changes in functional, musculoeskeletal, and stress biomarkers variables after the intervention, and to evaluate the cardiorespiratory adaptation to the RAGT.
A convenience sample of 10-12 participants will be selected, who will serve as their own control. It has been taken into account that previous studies conducted on pediatric population with CP this sample size is adequate.
At the beginning of the study, 50% of the participants will be part of the RAGT group, which will perform 2 weekly sessions of RAGT plus conventional therapy; and the other 50% will belong to the conventional physical therapy group. The study consists of phases 1 and 2 of treatment with a washout period between phases: after "phase 1" (8 weeks of therapy in one of the two groups), there will be 4 weeks of washout, after which each patient will cross over to the other group in "phase 2" (for 8 weeks).
Participants will be assessed before phase 1 (T1), after phase 1 (T2), before phase 2 (T3) and after phase 2 (T4).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized crossover clinical trial.
| Arm | Type | Receives |
|---|---|---|
| robot assisted gait training plus conventional physical therapy | Experimental | Combination Product: Robot assisted gait training plus conventional physical therapyParticipants will complete 8 weeks of intervention of robot assisted gait training plus conventional physical therapy. |
| Conventional physical therapy | Active comparator | Other: Conventional pjysical therapyParticipants will complete 8 weeks of conventional therapy. |
Who may qualify
- Ages
- 1 year to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Pediactric population with neurodevelopmental disorders who have been diagnosed with cerebral palsy.
- With a level IV or V of the GMFCS.
- Adapted to the school environment (> 6 months).
- Unable to stand without support.
- Receiving conventional physiotherapy (> 6 months).
Key exclusion criteria (7 listed)
- Severe spinal deformity.
- Severe hip dysplasia.
- Knee and hip flexion greater than 20º.
- Children treated surgically within the 1-year period prior to the evaluation date.
- Skin inflammation and open skin lesions around the trunk or limbs.
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 plus conventional physical therapyParticipants will complete 8 weeks of intervention of robot assisted gait training with the ATLAS 2030 exoskeleton (Marsi Bionics) owned by the school which they attend to. They will have 2 weekly sessions (16 sessions in total) for 4 weeks. Each session will last up to 1 hour (depending on the child's tolerance) although a minimum of 30 minutes per session and a minimum of 12 sessions will be set in this time. The training mode will be automatic. In addition, they will continue to carry out the rest of their usual treatments. | Combination product | robot assisted gait training plus conventional physical therapy |
| Conventional pjysical therapyParticipants will complete 8 weeks of conventional therapy, with 2 sessions per week (16 sessions total). During the conventional treatment period, participants will continue with the conventional physical therapy they have received thus far. The content of the usual care treatment does not specifically address gait training, but consists of elements addressing range of motion, tone reduction, balance, activities of daily living, etc. The conventional intervention may be different for each individual based on their needs (to represent usual care), however, participants will be advised not to change the intervention, type, and frequency during the study. | Other | Conventional physical therapy |
Primary outcome
Body composition, fat %
Time frame: Before phase 1 (T1, pre intervention), after phase 1 (T2, after 8 weeks intervention), before phase 2 (T3, pre intervention) and after phase 2 (T4, after 8 weeks intervention).
Measured by bioimpedanciometry (BIA): fat (%).
Body composition, fat in kg
Time frame: Before phase 1 (T1, pre intervention), after phase 1 (T2, after 8 weeks intervention), before phase 2 (T3, pre intervention) and after phase 2 (T4, after 8 weeks intervention).
Measured by bioimpedanciometry (BIA): fat (kg)
Body composition, lean mass (kg)
Time frame: Before phase 1 (T1, pre intervention), after phase 1 (T2, after 8 weeks intervention), before phase 2 (T3, pre intervention) and after phase 2 (T4, after 8 weeks intervention).
Measured by bioimpedanciometry (BIA): lean mass (kg), lean mass (%), total mass (%), dry lean weight (%), Body mass index, and resistance at 50 kHz measured in Ohms
Body composition, lean mass (%)
Time frame: Before phase 1 (T1, pre intervention), after phase 1 (T2, after 8 weeks intervention), before phase 2 (T3, pre intervention) and after phase 2 (T4, after 8 weeks intervention).
Measured by bioimpedanciometry (BIA): lean mass (%).
Body composition, dry lean weight
Time frame: Before phase 1 (T1, pre intervention), after phase 1 (T2, after 8 weeks intervention), before phase 2 (T3, pre intervention) and after phase 2 (T4, after 8 weeks intervention).
Measured by bioimpedanciometry (BIA): dry lean weight (%).
Bone mineral density.
Time frame: Before phase 1 (T1, pre intervention), after phase 1 (T2, after 8 weeks intervention), before phase 2 (T3, pre intervention) and after phase 2 (T4, after 8 weeks intervention).
Measured by ultrasound densitometry.
14 secondary outcomes
Functional and musculoeskeletal assessmement, clinical data.
Time frame: Before phase 1 (T1, pre intervention), after phase 1 (T2, after 8 weeks intervention), before phase 2 (T3, pre intervention) and after phase 2 (T4, after 8 weeks intervention).
Functional and musculoeskeletal assessmement, musculoskeletal history.
Time frame: Before phase 1 (T1, pre intervention), after phase 1 (T2, after 8 weeks intervention), before phase 2 (T3, pre intervention) and after phase 2 (T4, after 8 weeks intervention).
Functional and musculoeskeletal assessmement, disability assessment
Time frame: Before phase 1 (T1, pre intervention), after phase 1 (T2, after 8 weeks intervention), before phase 2 (T3, pre intervention) and after phase 2 (T4, after 8 weeks intervention).
Functional and musculoeskeletal assessmement, range of motion
Time frame: Before phase 1 (T1, pre intervention), after phase 1 (T2, after 8 weeks intervention), before phase 2 (T3, pre intervention) and after phase 2 (T4, after 8 weeks intervention).
Functional and musculoeskeletal assessmement, spasticity
Time frame: Before phase 1 (T1, pre intervention), after phase 1 (T2, after 8 weeks intervention), before phase 2 (T3, pre intervention) and after phase 2 (T4, after 8 weeks intervention).
Functional and musculoeskeletal assessmement, functional capacity
Time frame: Before phase 1 (T1, pre intervention), after phase 1 (T2, after 8 weeks intervention), before phase 2 (T3, pre intervention) and after phase 2 (T4, after 8 weeks intervention).
Anthropometric measurements, weight
Time frame: Before phase 1 (T1, pre intervention), after phase 1 (T2, after 8 weeks intervention), before phase 2 (T3, pre intervention) and after phase 2 (T4, after 8 weeks intervention).
Anthropometric measurements, height
Time frame: Before phase 1 (T1, pre intervention), after phase 1 (T2, after 8 weeks intervention), before phase 2 (T3, pre intervention) and after phase 2 (T4, after 8 weeks intervention).
Anthropometric measurements, BMI
Time frame: Before phase 1 (T1, pre intervention), after phase 1 (T2, after 8 weeks intervention), before phase 2 (T3, pre intervention) and after phase 2 (T4, after 8 weeks intervention).
Anthropometric measurements, circumferences
Time frame: Before phase 1 (T1, pre intervention), after phase 1 (T2, after 8 weeks intervention), before phase 2 (T3, pre intervention) and after phase 2 (T4, after 8 weeks intervention).
Nutritional status
Time frame: Before phase 1 (T1, pre intervention), after phase 1 (T2, after 8 weeks intervention), before phase 2 (T3, pre intervention) and after phase 2 (T4, after 8 weeks intervention).
Postural ability
Time frame: Before phase 1 (T1, pre intervention), after phase 1 (T2, after 8 weeks intervention), before phase 2 (T3, pre intervention) and after phase 2 (T4, after 8 weeks intervention).
Cardio-respiratory measurement, heart rate
Time frame: Before phase 1 (T1, pre intervention), after phase 1 (T2, after 8 weeks intervention), before phase 2 (T3, pre intervention) and after phase 2 (T4, after 8 weeks intervention).
Cardio-respiratory measurement, oxygen saturation
Time frame: Before phase 1 (T1, pre intervention), after phase 1 (T2, after 8 weeks intervention), before phase 2 (T3, pre intervention) and after phase 2 (T4, after 8 weeks intervention).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Background: PubMed 17108800Engsberg JR, Ross SA, Collins DR. Increasing ankle strength to improve gait and function in children with cerebral palsy: a pilot study. Pediatr Phys Ther. 2006 Winter;18(4):266-75. doi: 10.1097/01.pep.0000233023.33383.2b.
- Background: PubMed 36669727McCormick AM, Alazem H, Zaidi S, Barrowman NJ, Ward LM, McMillan HJ, Longmuir P, Larin M, Dalton K. A randomized, cross-over trial comparing the effect of innovative robotic gait training and functional clinical therapy in children with cerebral palsy; a protocol to test feasibility. Contemp Clin Trials. 2023 Apr;127:107086. doi: 10.1016/j.cct.2023.107086. Epub 2023 Jan 17.
- Background: PubMed 27984466Peungsuwan P, Parasin P, Siritaratiwat W, Prasertnu J, Yamauchi J. Effects of Combined Exercise Training on Functional Performance in Children With Cerebral Palsy: A Randomized-Controlled Study. Pediatr Phys Ther. 2017 Jan;29(1):39-46. doi: 10.1097/PEP.0000000000000338.
- Background: PubMed 25500686Zhao X, Chen M, Du S, Li H, Li X. Evaluation of stress and pain in young children with cerebral palsy during early developmental intervention programs: a descriptive study. Am J Phys Med Rehabil. 2015 Mar;94(3):169-75; quiz 176-9. doi: 10.1097/PHM.0000000000000252.
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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. This study is not recruiting at the moment.
ANNA ARNAL-GOMEZ, Dr. principal investigator
University of Valencia
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 plus conventional physical therapy and Conventional pjysical therapy in people with Neurodevelopmental Disorders and Cerebral Palsy, run by University of Valencia at 1 site in Spain.
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 8 inclusion and 7 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: finished, as of the sponsor's last update on 16 Oct 2026. 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body composition, fat % (time frame: Before phase 1 (T1, pre intervention), after phase 1 (T2, after 8 weeks intervention), before phase 2 (T3, pre intervention) and after phase 2 (T4, after 8 weeks intervention).). The study lists 6 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 NCT06645795, which also lists 4 linked publications.
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 16 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.