Cerebral PalsyNCT07049523
Robotic Exoskeleton Gait Training for Children With Cerebral Palsy
A study testing Robotic-assisted gait training in people with Cerebral Palsy, run by Hunan Normal University at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate whether robotic-assisted gait training can improve motor function, walking capacity, joint flexibility, muscle structure, and psychological well-being in children aged 6 to 12 years with spastic cerebral palsy (CP) classified as Gross Motor Function Classification System… Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Robotic-assisted gait training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2025to 1 Mar 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- No history of heart disease or family history of heart disease;
- Children classified as GMFCS level IV;
- Dependent on assistive mobility devices, such as wheelchairs or posture support walkers, for activities of daily living;
- Medically stable and able to sit upright for at least 30 minutes;
- Able to understand simple verbal or visual instructions.
Who cannot join
- Aged under 6 years or over 12 years;
- Received botulinum toxin A injections for lower limb muscles within six months prior to baseline assessment;
- Implanted with an intrathecal baclofen pump, or has a history of lower limb-related orthopedic or neurosurgical interventions (such as tendon lengthening, osteotomy, or selective dorsal rhizotomy);
- Has uncontrolled epilepsy, severe cognitive impairment, or other comorbidities.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Protocol for the "Stand the Future" Trial: Robotic Exoskeleton Gait Training for Non-Ambulatory Children With Spastic Cerebral Palsy
The goal of this clinical trial is to evaluate whether robotic-assisted gait training can improve motor function, walking capacity, joint flexibility, muscle structure, and psychological well-being in children aged 6 to 12 years with spastic cerebral palsy (CP) classified as Gross Motor Function Classification System (GMFCS) level IV.
The main questions it aims to answer are:
Read more
Can robotic gait training improve gross motor function and walking ability in children with GMFCS level IV CP?
Does robotic training enhance joint range of motion, muscle morphology, and psychological satisfaction in this population?
Researchers will compare a robotic gait training group to a usual care group to see if the robotic intervention leads to better physical and psychological outcomes.
Participants will:
Be randomly assigned to receive either robotic gait training or continue their usual care for 6 months
Complete three 45-minute training sessions per week (robotic group only)
Undergo physical and psychological assessments at the beginning, midpoint, and end of the study
Have their gross motor function, walking ability, joint flexibility, muscle structure, and quality of life measured using validated tools
Read the detailed description
Cerebral palsy (CP) remains the most common motor disability in childhood, affecting approximately 17 million people worldwide, with an estimated 2-3 per 1,000 live births. In China alone, the number of children with CP is estimated to exceed 6 million, with approximately 40,000 new cases occurring each year. Notably, a substantial proportion of these children are classified as Gross Motor Function Classification System (GMFCS) levels IV or V, indicating they are either non-ambulatory or severely limited in voluntary movement (Li et al., 2018). Children with GMFCS levels IV and V often exhibit pronounced spasticity, limited voluntary muscle control, and severe deficits in selective motor control. Muscle fibers in these children show altered histological features including reduced cross-sectional area, increased collagen deposition, and impaired oxidative capacity. These pathological characteristics further exacerbate limitations in force generation and movement efficiency. These children experience profound impairments in mobility, postural control, and independence, presenting critical challenges for their physical and psychological development.
As the investigators recently reported in a systematic review, current physical rehabilitation strategies for children with CP are derived from studies involving ambulatory children (GMFCS I-III), while the severely affected population (GMFCS IV-V) remains underrepresented in the literature. The absence of walking ability in these children precludes participation in many conventional physiotherapeutic or strength-based programs, resulting in stagnated motor development and a cascade of secondary complications including muscle atrophy, contractures, and social exclusion. In addition to clinical burdens, non-ambulatory children with CP present significant lifelong economic challenges for families and healthcare systems. Estimates suggest that the lifetime cost of care for a single individual with CP can exceed $1.6 million USD in high-income countries, with costs related to direct medical care, assistive equipment, caregiving, and loss of productivity. In China, the economic burden is compounded by disparities in access to rehabilitation services and limited insurance coverage for long-term care.
Recent advancements in robotics and wearable technologies have opened new avenues for restoring movement in neurologically impaired individuals. Robotic exoskeletons and powered orthoses offer the potential to provide task-specific, repetitive, and intensive gait training while minimizing therapist workload. Such devices have shown promise in adult populations with spinal cord injury and stroke, and early-stage trials have extended these technologies to pediatric neuromuscular disorders, including CP. However, empirical data on the feasibility, safety, and efficacy of prolonged robotic gait training in children with GMFCS IV and V classifications are virtually nonexistent.
This protocol outlines a prospective 6-month intervention trial aimed at evaluating the effectiveness of robotic exoskeleton gait training on motor and psychological outcomes in children with severe CP. Through this study, the investigators aim to establish initial empirical evidence for the feasibility and potential benefits of exoskeleton-assisted rehabilitation in children who are traditionally excluded from active gait training. The investigators hypothesize that children with GMFCS level IV CP will demonstrate measurable improvements in motor function, mobility, and subjective well-being. This trial addresses a major gap in pediatric neurorehabilitation and may provide a critical foundation for scaling up robotic interventions in underserved clinical populations.
- Conditions
- Cerebral Palsy
- Being tested
- Robotic-assisted gait training
- Keywords
- fascicle length, muscle volume, motor development, gait, 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.
Robotic-assisted gait trainingDevice
The intervention group will receive robotic-assisted gait training using the RoboCT Pediatric Lower Limb Rehabilitation Robot (RoboCT Limited Co., Hangzhou, China), a pediatric exoskeleton system designed for overground locomotor training. This device integrates real-time motion sensing, adaptive control algorithms, and customizable joint actuation to deliver precise and individualized gait training for children with minimal voluntary motor control. The system allows for the modulation of key gait parameters including joint angles, step length, and walking speed, and incorporates both postural correction and dynamic support harnessing to maintain safety and alignment throughout the session.
Robotic sessions will be conducted three times per week over a period of 24 weeks, with each session lasting approximately 45 minutes. All sessions will be conducted at a designat
| Study group | Role | What they receive |
|---|---|---|
| Regular rehabilitation | No intervention | Participants assigned to the regular rehabilitation (control) group will continue receiving their usual care as determined by their caregivers. Usual care may include activities such as home-based stretching, passive range-of-motion exercises, school-based physiotherapy, or outpatient therapy. There will be no restrictions on care choices. |
| Robotic-assisted gait training | Experimental | The intervention group will receive robotic-assisted gait training using the RoboCT Pediatric Lower Limb Rehabilitation Robot (RoboCT Limited Co., Hangzhou, China), a pediatric exoskeleton system designed for overground locomotor training. Receives: Device: Robotic-assisted gait training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gross Motor Function Measure - Item Set (GMFM-IS)
Gross motor function will be evaluated using the Gross Motor Function Measure - Item Set (GMFM-IS), a validated short-form tool derived from the full GMFM-66, appropriate for assessing changes in children with CP (Russell et al., 2010). It focuses on key motor tasks across five dimensions: lying and rolling, sitting, crawling and kneeling, standing, and walking, running, and jumping. In this study, trained evaluators will observe children as they perform selected motor tasks from the GMFM-IS. Each task will be scored on a 4-point ordinal scale: 0 = does not initiate; 1 = initiates (<10% of the task); 2 = partially completes (10-99%); 3 = completes the task independently. The assessment will take place in a quiet, controlled environment with standardized instructions and safety precautions. Scores will be entered into the Gross Motor Ability Estimator software to generate interval-level total scores, allowing for sensitive tracking of changes in motor function over time.
Measured: Baseline (week 0), mid-point (week 12), and post-intervention (week 24)
1-minute walk test
To assess functional walking capacity, participants will undergo the 1-minute walk test, performed on a marked 20-meter indoor course. Children will be instructed to walk as quickly and safely as possible without running, and the total distance covered in 60 seconds will be recorded. For participants who require orthoses or walkers, such assistive devices will be permitted during testing, consistent with real-world functionality.
Measured: Baseline (week 0), mid-point (week 12), and post-intervention (week 24)
Passive ankle joint range of motion
Passive ankle joint range of motion (ROM) will be measured using an isokinetic dynamometer. Each child will be seated with the knee fully extended, the ankle joint aligned with the dynamometer's rotational axis, and the foot securely fixed to a footplate. Passive dorsiflexion and plantar flexion will be conducted through full available range to determine ROM and passive torque.
Measured: Baseline (week 0), mid-point (week 12), and post-intervention (week 24)
Muscle morphological properties
Muscle morphological properties of the lower limbs will be assessed via ultrasonography using a 6-12 MHz linear transducer (Meinianda BX-5, Zibo, China). Images will be acquired for the rectus femoris, quadriceps femoris, and medial gastrocnemius on both lower limbs. Standardized anatomical landmarks will be used for probe placement, and muscle thickness and muscle fascicle length will be quantified offline by blinded assessors.
Measured: Baseline (week 0) and post-intervention (week 24)
Secondary outcomes (1)
Pediatric Quality of Life Inventory
Psychological satisfaction and treatment engagement will be evaluated using the Pediatric Quality of Life Inventory (PedsQL™ 3.0 NMM), which is validated for children with chronic motor impairments (Iannaccone et al., 2009). This instrument includes child self-report and parent-proxy versions and assesses multiple dimensions including physical functioning, communication, and emotional well-being. Higher scores represent better perceived quality of life and satisfaction with daily function.
Measured: Baseline (week 0), mid-point (week 12), and post-intervention (week 24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start1 Oct 2025
- Primary completion1 Feb 2026
- Study completion1 Mar 2026
Why it stopped: The study was terminated due to regulatory conflicts.
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
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hunan Normal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Zhang, Hunan Normal University
- Investigators
- Bo Zhou, PhD, Study director, Hunan Normal University, College of Physical Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07049523
- Sponsor's protocol ID
- 2025-506
- Status last verified
- Jun 2026
- First submitted
- 25 Jun 2025
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD sharing is not approved in the institutional review board.
Publications
Xia B, Mi N, Wen Z, Zhang Y. Protocol for the "stand the future" trial: robotic exoskeleton gait training for non-ambulatory children with spastic cerebral palsy. Front Neurol. 2025 Oct 15;16:1651913. doi: 10.3389/fneur.2025.1651913. eCollection 2025.
PubMed 41170334
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol for the "Stand the Future" Trial: Robotic Exoskeleton Gait Training for Non-Ambulatory Children With Spastic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT07049523
- Acronym / sponsor ID
- 2025-506
- Conditions
- Cerebral Palsy
- Keywords
- fascicle length, muscle volume, motor development, gait, rehabilitation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated due to regulatory conflicts.
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Hunan Normal UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 3 Jul 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.
The goal of this clinical trial is to evaluate whether robotic-assisted gait training can improve motor function, walking capacity, joint flexibility, muscle structure, and psychological well-being in children aged 6 to 12 years with spastic cerebral palsy (CP) classified as Gross Motor Function Classification System (GMFCS) level IV.
The main questions it aims to answer are:
Can robotic gait training improve gross motor function and walking ability in children with GMFCS level IV CP?
Does robotic training enhance joint range of motion, muscle morphology, and psychological satisfaction in this population?
Researchers will compare a robotic gait training group to a usual care group to see if the robotic intervention leads to better physical and psychological outcomes.
Participants will:
Be randomly assigned to receive either robotic gait training or continue their usual care for 6 months
Complete three 45-minute training sessions per week (robotic group only)
Undergo physical and psychological assessments at the beginning, midpoint, and end of the study
Have their gross motor function, walking ability, joint flexibility, muscle structure, and quality of life measured using validated tools
Detailed description
Cerebral palsy (CP) remains the most common motor disability in childhood, affecting approximately 17 million people worldwide, with an estimated 2-3 per 1,000 live births. In China alone, the number of children with CP is estimated to exceed 6 million, with approximately 40,000 new cases occurring each year. Notably, a substantial proportion of these children are classified as Gross Motor Function Classification System (GMFCS) levels IV or V, indicating they are either non-ambulatory or severely limited in voluntary movement (Li et al., 2018). Children with GMFCS levels IV and V often exhibit pronounced spasticity, limited voluntary muscle control, and severe deficits in selective motor control. Muscle fibers in these children show altered histological features including reduced cross-sectional area, increased collagen deposition, and impaired oxidative capacity. These pathological characteristics further exacerbate limitations in force generation and movement efficiency. These children experience profound impairments in mobility, postural control, and independence, presenting critical challenges for their physical and psychological development.
As the investigators recently reported in a systematic review, current physical rehabilitation strategies for children with CP are derived from studies involving ambulatory children (GMFCS I-III), while the severely affected population (GMFCS IV-V) remains underrepresented in the literature. The absence of walking ability in these children precludes participation in many conventional physiotherapeutic or strength-based programs, resulting in stagnated motor development and a cascade of secondary complications including muscle atrophy, contractures, and social exclusion. In addition to clinical burdens, non-ambulatory children with CP present significant lifelong economic challenges for families and healthcare systems. Estimates suggest that the lifetime cost of care for a single individual with CP can exceed $1.6 million USD in high-income countries, with costs related to direct medical care, assistive equipment, caregiving, and loss of productivity. In China, the economic burden is compounded by disparities in access to rehabilitation services and limited insurance coverage for long-term care.
Recent advancements in robotics and wearable technologies have opened new avenues for restoring movement in neurologically impaired individuals. Robotic exoskeletons and powered orthoses offer the potential to provide task-specific, repetitive, and intensive gait training while minimizing therapist workload. Such devices have shown promise in adult populations with spinal cord injury and stroke, and early-stage trials have extended these technologies to pediatric neuromuscular disorders, including CP. However, empirical data on the feasibility, safety, and efficacy of prolonged robotic gait training in children with GMFCS IV and V classifications are virtually nonexistent.
This protocol outlines a prospective 6-month intervention trial aimed at evaluating the effectiveness of robotic exoskeleton gait training on motor and psychological outcomes in children with severe CP. Through this study, the investigators aim to establish initial empirical evidence for the feasibility and potential benefits of exoskeleton-assisted rehabilitation in children who are traditionally excluded from active gait training. The investigators hypothesize that children with GMFCS level IV CP will demonstrate measurable improvements in motor function, mobility, and subjective well-being. This trial addresses a major gap in pediatric neurorehabilitation and may provide a critical foundation for scaling up robotic interventions in underserved clinical populations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regular rehabilitation | No intervention | –Participants assigned to the regular rehabilitation (control) group will continue receiving their usual care as determined by their caregivers. Usual care may include activities such as home-based stretching, passive range-of-motion exercises, school-based physiotherapy, or outpatient therapy. There will be no restrictions on care choices. |
| Robotic-assisted gait training | Experimental | Device: Robotic-assisted gait trainingThe intervention group will receive robotic-assisted gait training using the RoboCT Pediatric Lower Limb Rehabilitation Robot (RoboCT Limited Co., Hangzhou, China), a pediatric exoskeleton system designed for overground locomotor training. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- No history of heart disease or family history of heart disease;
- Children classified as GMFCS level IV;
- Dependent on assistive mobility devices, such as wheelchairs or posture support walkers, for activities of daily living;
- Medically stable and able to sit upright for at least 30 minutes;
- Able to understand simple verbal or visual instructions.
Key exclusion criteria (4 listed)
- Aged under 6 years or over 12 years;
- Received botulinum toxin A injections for lower limb muscles within six months prior to baseline assessment;
- Implanted with an intrathecal baclofen pump, or has a history of lower limb-related orthopedic or neurosurgical interventions (such as tendon lengthening, osteotomy, or selective dorsal rhizotomy);
- Has uncontrolled epilepsy, severe cognitive impairment, or other comorbidities.
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 |
|---|---|---|
| Robotic-assisted gait trainingThe intervention group will receive robotic-assisted gait training using the RoboCT Pediatric Lower Limb Rehabilitation Robot (RoboCT Limited Co., Hangzhou, China), a pediatric exoskeleton system designed for overground locomotor training. This device integrates real-time motion sensing, adaptive control algorithms, and customizable joint actuation to deliver precise and individualized gait training for children with minimal voluntary motor control. The system allows for the modulation of key gait parameters including joint angles, step length, and walking speed, and incorporates both postural correction and dynamic support harnessing to maintain safety and alignment throughout the session. Robotic sessions will be conducted three times per week over a period of 24 weeks, with each session lasting approximately 45 minutes. All sessions will be conducted at a designat | Device | Robotic-assisted gait training |
Primary outcome
Gross Motor Function Measure - Item Set (GMFM-IS)
Time frame: Baseline (week 0), mid-point (week 12), and post-intervention (week 24)
Gross motor function will be evaluated using the Gross Motor Function Measure - Item Set (GMFM-IS), a validated short-form tool derived from the full GMFM-66, appropriate for assessing changes in children with CP (Russell et al., 2010). It focuses on key motor tasks across five dimensions: lying and rolling, sitting, crawling and kneeling, standing, and walking, running, and jumping. In this study, trained evaluators will observe children as they perform selected motor tasks from the GMFM-IS. Each task will be scored on a 4-point ordinal scale: 0 = does not initiate; 1 = initiates (<10% of the task); 2 = partially completes (10-99%); 3 = completes the task independently. The assessment will take place in a quiet, controlled environment with standardized instructions and safety precautions. Scores will be entered into the Gross Motor Ability Estimator software to generate interval-level total scores, allowing for sensitive tracking of changes in motor function over time.
1-minute walk test
Time frame: Baseline (week 0), mid-point (week 12), and post-intervention (week 24)
To assess functional walking capacity, participants will undergo the 1-minute walk test, performed on a marked 20-meter indoor course. Children will be instructed to walk as quickly and safely as possible without running, and the total distance covered in 60 seconds will be recorded. For participants who require orthoses or walkers, such assistive devices will be permitted during testing, consistent with real-world functionality.
Passive ankle joint range of motion
Time frame: Baseline (week 0), mid-point (week 12), and post-intervention (week 24)
Passive ankle joint range of motion (ROM) will be measured using an isokinetic dynamometer. Each child will be seated with the knee fully extended, the ankle joint aligned with the dynamometer's rotational axis, and the foot securely fixed to a footplate. Passive dorsiflexion and plantar flexion will be conducted through full available range to determine ROM and passive torque.
Muscle morphological properties
Time frame: Baseline (week 0) and post-intervention (week 24)
Muscle morphological properties of the lower limbs will be assessed via ultrasonography using a 6-12 MHz linear transducer (Meinianda BX-5, Zibo, China). Images will be acquired for the rectus femoris, quadriceps femoris, and medial gastrocnemius on both lower limbs. Standardized anatomical landmarks will be used for probe placement, and muscle thickness and muscle fascicle length will be quantified offline by blinded assessors.
1 secondary outcome
Pediatric Quality of Life Inventory
Time frame: Baseline (week 0), mid-point (week 12), and post-intervention (week 24)
Results and safety
The study was stopped early (reason given: The study was terminated due to regulatory conflicts.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Derived from this study: PubMed 41170334Xia B, Mi N, Wen Z, Zhang Y. Protocol for the "stand the future" trial: robotic exoskeleton gait training for non-ambulatory children with spastic cerebral palsy. Front Neurol. 2025 Oct 15;16:1651913. doi: 10.3389/fneur.2025.1651913. eCollection 2025.
- Individual participant dataSharing planned: No. IPD sharing is not approved in the institutional review board.
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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.
Bo Zhou, PhD study director
Hunan Normal University, College of Physical Education
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic-assisted gait training in people with Cerebral Palsy, run by Hunan Normal University at 1 site in China.
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 4 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: stopped early, as of the sponsor's last update on 22 Jun 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 China. 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 was stopped early (reason given: The study was terminated due to regulatory conflicts.). Results are not available in the source record.
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?
Gross Motor Function Measure - Item Set (GMFM-IS) (time frame: Baseline (week 0), mid-point (week 12), and post-intervention (week 24)). The study lists 4 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 NCT07049523, 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 2026.