Child BehaviorNCT05805410
Neuromuscular Mechanisms of Specific Trunk Interventions in Children With CP
A study testing robotic hippotherapy and Conventional physical therapy in people with Child Behavior, run by Shirley Ryan AbilityLab at 1 site in United States.
Trial summary
Determine the effect of repeated pelvis perturbation training on trunk posture and locomotor function in children with CP. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Child Behavior
- What is being tested?
- robotic hippotherapy and Conventional physical therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2022to 31 Dec 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 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with a diagnosis of bilateral spastic CP attributed to complications of prematurity, intracranial hemorrhage and periventricular leukmalacia according to the definition of Bax.
- Children aged 4 to 12 years old without Botulinum toxin treatment within 6 months, and without surgeries (such as selective dorsal rhizotomy) within 12 months before the onset of the training.
- Subjects will be able to remain seated without help for ≥10s.
- GMFCS levels will be I to IV.
- Children must be able to signal pain, fear or discomfort reliably.
- Children with mild scoliosis (Cobb angle < 20 °).
- Children with CP who have no prior hippotherapy experiences within 6 months.
Who cannot join
- severe lower extremity contractures, fractures, osseous instabilities, osteoporosis.
- severe disproportional bone growth.
- unhealed skin lesions in the lower extremities.
- thromboembolic diseases, cardiovascular instability.
- aggressive or self-harming behaviors.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Shirley Ryan AbilityLab
Chicago, Illinois, 60611
Ming Wu, PhD, 3122380700, mwu@ric.org
About this study
Official title: Neuromuscular Mechanisms of Specific Trunk Interventions in Children With Cerebral Palsy
Determine the effect of repeated pelvis perturbation training on trunk posture and locomotor function in children with CP.
Read the detailed description
We will determine whether repeat exposure to pelvis perturbation during sitting astride will induce functional improvements in trunk postural control and locomotion in children with CP.
- Conditions
- Child Behavior
- Being tested
- robotic hippotherapy, Conventional physical therapy
- Medical subject headings
- Child Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
robotic hippotherapyBehavioural
A custom designed cable-driven robotic system that mimics horseback movement during walking was used in this study.
Conventional physical therapyBehavioural
Stretching of trunk and leg muscles, followed by sitting and standing balance training, and conventional treadmill walking.
| Study group | Role | What they receive |
|---|---|---|
| Robotic hippotherapy | Experimental | For the robotic training group, each subject will be trained for 40 minutes. Specifically, each participant will sit astride on a robotic horse with the force perturbation will be applied in the anterior-posterior direction and up/down direction. Receives: Behavioral: robotic hippotherapy |
| Conventional physical therapy | Active comparator | For the conventional physical therapy group, each subject will be trained for 40 minutes, which will include 10 minutes of stretching, followed by 10 minutes of sitting and 10 minutes of standing balance training, and 10 minutes of treadmill walking. Receives: Behavioral: Conventional physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Trunk Control Measurement Scale (TCMS) score from baseline.
The maximum value for the total TCMS is 58 points (no unit). Specifically, there is 20 points for the category 'static sitting balance', 28 points for 'selective movement control', and 10 points for 'dynamic reaching'). A higher TCMS scores indicates a better motor performance in trunk control.
Measured: baseline, post 6 weeks of training and 8 weeks after the end of training.
Secondary outcomes (3)
Change in Walking speed from baseline
Overground walking speed
Measured: baseline, post 6 weeks of training and 8 weeks after the end of training.
Chang in 6-minute walking distance from baseline
Walking distance within 6 minutes
Measured: baseline, post 6 weeks of training and 8 weeks after the end of training.
Change in GMFM-66
Gross Motor Function Measure
Measured: baseline, post 6 weeks of training and 8 weeks after the end of training.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2023
- Study start1 Nov 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child BehaviorStudies of the same condition, open and under way.
- More trials run by Shirley Ryan AbilityLabThe sponsor's other registered studies.
- 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
- Participants will be randomly assigned to two groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ming Wu, Shirley Ryan AbilityLab
- Investigators
- Ming Wu, Principal investigator, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05805410
- Sponsor's protocol ID
- R01NS115487
- Status last verified
- May 2025
- First submitted
- 7 Dec 2022
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromuscular Mechanisms of Specific Trunk Interventions in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05805410
- Acronym / sponsor ID
- R01NS115487
- Conditions
- Child Behavior
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Apr 2023 (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.
Determine the effect of repeated pelvis perturbation training on trunk posture and locomotor function in children with CP.
Detailed description
We will determine whether repeat exposure to pelvis perturbation during sitting astride will induce functional improvements in trunk postural control and locomotion in children with CP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to two groups
| Arm | Type | Receives |
|---|---|---|
| Robotic hippotherapy | Experimental | Behavioral: robotic hippotherapyFor the robotic training group, each subject will be trained for 40 minutes. Specifically, each participant will sit astride on a robotic horse with the force perturbation will be applied in the anterior-posterior direction and up/down direction. |
| Conventional physical therapy | Active comparator | Behavioral: Conventional physical therapyFor the conventional physical therapy group, each subject will be trained for 40 minutes, which will include 10 minutes of stretching, followed by 10 minutes of sitting and 10 minutes of standing balance training, and 10 minutes of treadmill walking. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Children with a diagnosis of bilateral spastic CP attributed to complications of prematurity, intracranial hemorrhage and periventricular leukmalacia according to the definition of Bax.
- Children aged 4 to 12 years old without Botulinum toxin treatment within 6 months, and without surgeries (such as selective dorsal rhizotomy) within 12 months before the onset of the training.
- Subjects will be able to remain seated without help for ≥10s.
- GMFCS levels will be I to IV.
- Children must be able to signal pain, fear or discomfort reliably.
Key exclusion criteria (5 listed)
- severe lower extremity contractures, fractures, osseous instabilities, osteoporosis.
- severe disproportional bone growth.
- unhealed skin lesions in the lower extremities.
- thromboembolic diseases, cardiovascular instability.
- aggressive or self-harming behaviors.
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 hippotherapyA custom designed cable-driven robotic system that mimics horseback movement during walking was used in this study. | Behavioural | Robotic hippotherapy |
| Conventional physical therapyStretching of trunk and leg muscles, followed by sitting and standing balance training, and conventional treadmill walking. | Behavioural | Conventional physical therapy |
Primary outcome
Change in Trunk Control Measurement Scale (TCMS) score from baseline.
Time frame: baseline, post 6 weeks of training and 8 weeks after the end of training.
The maximum value for the total TCMS is 58 points (no unit). Specifically, there is 20 points for the category 'static sitting balance', 28 points for 'selective movement control', and 10 points for 'dynamic reaching'). A higher TCMS scores indicates a better motor performance in trunk control.
3 secondary outcomes
Change in Walking speed from baseline
Time frame: baseline, post 6 weeks of training and 8 weeks after the end of training.
Chang in 6-minute walking distance from baseline
Time frame: baseline, post 6 weeks of training and 8 weeks after the end of training.
Change in GMFM-66
Time frame: baseline, post 6 weeks of training and 8 weeks after the end of training.
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 3 Jun 2025.
- 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.
Ming Wu principal investigator
Shirley Ryan AbilityLab
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 hippotherapy and Conventional physical therapy in people with Child Behavior, run by Shirley Ryan AbilityLab at 1 site in United States.
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 7 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 3 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 United States. 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 Ming Wu (3122380700, w-ming@northwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Trunk Control Measurement Scale (TCMS) score from baseline. (time frame: baseline, post 6 weeks of training and 8 weeks after the end of training.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jun 2025.