Cerebral PalsyNCT04897347
Robotic TruST-Postural Intervention for Children With Cerebral Palsy
A study testing Robotic Trunk-Support-Trainer (TruST) and Static Trunk Support in people with Cerebral Palsy, run by Teachers College, Columbia University at 2 sites in United States.
Trial summary
The purpose of this study is to test the efficacy of a motor learning-based postural and reaching control intervention delivered with the robotic Trunk-Support-Trainer (TruST) compared to the same motor learning-based intervention delivered with Static Trunk Support Equipment in children with cerebral palsy (CP)… Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Robotic Trunk-Support-Trainer (TruST) and Static Trunk Support
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 2 sitesUnited States
- Study dates
- 26 Feb 2022to Jun 2027
- 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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 6-17 years
- Diagnosis of Bilateral CP: diplegia, triplegia, or quadriplegia
- Gross Motor Function Classification Systems-Expanded \& Review (GMFCS) levels III or IV
- Ability to sit 5s with trunk support between mid-ribs and pelvis (SATCo = 3-7)
- Cognitive capacity to follow basic verbal instructions (i.e., "do not put your hands on your lap" or "follow and reach the toy")
Who cannot join
- Absent head control (SATCo = 1)
- Current medical illness unrelated to CP at the time of the study
- Severe dyskinesia that prevents the child from maintaining sitting and recovering balance during reaching movements
- History of recurrent seizures (daily) or drug-resistance epilepsy
- Severe Spinal Deformities: scoliosis >40◦ and/or kyphosis >45◦
- Spinal osteosynthesis or orthopedic surgery of spine, upper or lower extremities in the last 6 months
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- Severe spasticity of biceps/triceps in both upper extremities (Modified Ashworth Scale = 4)
- Local chemodenervation therapy in spastic muscles (e.g., botulinum toxin or phenol injections) in upper or lower extremities in the previous 3 months or planned during the study
- Other major surgeries in the previous 6 months (if medically contraindicated)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Columbia University
New York, New York, 10027
Victor Santamaria, PT, PhD, 212-678-3332, vs2578@columbia.edu
- Recruiting
Teachers College, Columbia University
New York, New York, 10027
Karen Chin, MA, 212-678-3332, cpresearch@tc.columbia.edu
About this study
Official title: Postural Control Intervention With the Robotic Trunk-Support-Trainer (TruST) in Children With Cerebral Palsy: A Randomized Controlled Trial
The purpose of this study is to test the efficacy of a motor learning-based postural and reaching control intervention delivered with the robotic Trunk-Support-Trainer (TruST) compared to the same motor learning-based intervention delivered with Static Trunk Support Equipment in children with cerebral palsy (CP) classified as III and IV with the Gross Motor Function Classification System (GMFCS).
Read the detailed description
This study is a prospective Clinical Randomized Control Trial (RCT) in a group of 82 children with cerebral palsy. The experimental and control groups will receive effective postural-reaching training based on motor learning and control principles. In both groups, participants will engage in play and functional activities that elicit arm movement and challenge trunk postural control, and the motor tasks and activities will be progressed. The main difference is that the experimental group will be trained with TruST in order to add postural task-progression via assistive force fields; which will be tailored to the child's sitting control balance status across training sessions. However, in the control group, postural task-progression will be addressed by lowering the level of rigid trunk support segment by segment across training sessions. The trunk subregion where the support is placed will depend on the child's trunk control ability. Participants will be recruited from the United States.
- Conditions
- Cerebral Palsy
- Being tested
- Robotic Trunk-Support-Trainer (TruST), Static Trunk Support
- Keywords
- Posture, Reaching, Robotics, Motor Learning, Motor Control
- 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 Trunk-Support-Trainer (TruST)Device
This will involve tailoring the level of postural assistance via force fields and systematically introduce postural task-progression across training sessions. Age-appropriate activities, including toys and games, will be used in training.
- Twelve 2hr training sessions (3 times per week for 4 weeks)
Static Trunk SupportDevice
This will involve static support for the trunk via a trained therapist. Age-appropriate activities, including toys and games, will be used in training.
- Twelve 2hr training sessions (3 times per week for 4 weeks)
| Study group | Role | What they receive |
|---|---|---|
| Robotic Trunk-Support-Trainer (TruST) | Experimental | Postural-reaching control intervention with TruST Receives: Device: Robotic Trunk-Support-Trainer (TruST) |
| Static Trunk Support | Active comparator | Postural-reaching control intervention with Rigid Trunk Support Receives: Device: Static Trunk Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Modified Functional Reach Test (mFRT) after intervention
The mFRT measures proactive postural control during maximum reaching distance. It is a valid and reliable tool in CP; and it discriminates GMFCS levels.
Measured: Through study completion, an average of 4 months
Change in Postural Star-Sitting Test (PSST) after intervention
The PSST will be performed before and after interventions to monitor sitting control progression in both TruST- and control-intervention groups. The investigators have several motivations that rationalize this customized measurement. It: 1) is age-appropriate, 2) is goal-oriented, 3) directly measures sitting based on trunk control improvements, 4) is responsive to capture sitting workspace area increases, and 5) offers data with a straightforward functional interpretation.
Measured: Through study completion, an average of 4 months
Change in Box and Blocks Test (BBT) after intervention
The BBT examines manual dexterity. The child moves the maximum number of blocks (2.5cm2), one at a time, between the compartments of a partitioned box within 60s. B\&B is sensitive to post-intervention changes with the more- and less-affected hand. Arm displacement and grasping will be analyzed with Datavyu. An instruction manual has been created to standardize video-coding procedures and define the reaching variables. Grasping will be defined from the moment the hand contacts the block to the time this is lifted from the surface. Arm displacement will be defined from end of grasping to block release. Reaching performance will be the summation of grasping and arm displacement. Two coders will be used to determine video-coding reliability.
Measured: Through study completion, an average of 4 months
Secondary outcomes (6)
Change in Gross Motor Function Measure-Item Set (GMFM-IS) after intervention
The GMFM-IS determines the gross motor function of children with CP-A: lying and rolling, B: sitting, C: crawling, D: standing and E: walking, running \& jumping. It is an abbreviated and validated version of the GMFM-66. It includes an algorithm with three critical items to decide which one of four item sets is most appropriate to assess motor function and obtain a GMFM-66 score. GMFM has been shown to be valid, reliable, and responsive to change in CP. The minimum clinically important difference (MCID) is 0.8-1.6 for medium effect size and 1.3-2.6 for large effect size.
Measured: Through study completion, an average of 4 months
Change in Canadian Occupational Performance Measure (COPM) after intervention
The COPM will be used to investigate perceived parent- and child-based goals, and preferences that are specific to motor impediments in seated posture and reaching abilities that restrict participation. COPM can detect clinical important differences across time and above the MCID of 2 points.
Measured: Through study completion, an average of 4 months
Change in Participation and Environment Measure - Children and Youth (PEM-CY) after intervention
The PEM-CY is a valid and reliable tool to measure participation-home, school and community-including environmental factors. PEM-CY can capture post-intervention changes in each of its dimensions in children with physical disabilities.
Measured: Through study completion, an average of 4 months
Change in Seated Postural & Reaching Control (SP&R-co) after intervention
The theoretical framework, reliability, internal consistency, and construct validity of the SP\&R-co has been validated in CP. It targets children with moderate-to-severe CP within a play-oriented framework. Similar to the SATCo, the SP\&R-co follows a segment-by-segment approach to assess quantitatively sitting control across static, active, proactive (via bimanual and unimanual reaches), and reactive dimensions. Responsiveness has not been addressed, but the standard error measurement of each SP\&R-co dimension are available.
Measured: Through study completion, an average of 4 months
Change in Postural and Reaching Kinematics after intervention
We will follow the seated postural framework validated in the SP\&R-co to capture motor improvements in the next tasks: (1) Static Seated Task: Postural orientation and balance in sitting during 10s. (2) Active Seated Task: Simultaneous control of the trunk and head rotations when the child visually follows an object to the right and left at a 90° angle. (3) Proactive Seated Task: Sitting control via anticipatory and compensatory postural adjustments during direction-specific reaches straight and 45° to the right and left.
Measured: Through study completion, an average of 4 months
Change in Segmental Assessment of Trunk Control (SATCo) after intervention
The SATCo is a valid and reliable test in CP. The evaluator offers support at various trunk segments (shoulders, axillae, inferior angle of scapulae, on lower ribs, below lower ribs, and pelvis) to measure trunk control across 3 dimensions: static (during 5s), proactive (visually following an object), and reactive (postural responses to nudges). The score is from 1 (no head control) to 8 (full trunk control). Test responsiveness has not been established but studies show potential to identify trunk balance improvements in each of the tested trunk segments.
Measured: Through study completion, an average of 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2021
- Study start26 Feb 2022
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Teachers College, Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Columbia University
- Responsible party
- Sponsor
- Investigators
- Sunil Agrawal, PhD, Principal investigator, Columbia UniversityAndrew Gordon, PhD, Principal investigator, Teachers College, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04897347
- Sponsor's protocol ID
- AAAS7804
- Other IDs
- 1R01HD101903-01
- Status last verified
- Dec 2023
- First submitted
- 12 May 2021
- Last updated
- 22 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All study data will be made available via the Data and Specimen Hub (DASH), a data sharing platform of the Eunice Kennedy Shriver National Institute of Child Health and Development.
Publications
Santamaria V, Ai X, Chin K, Dutkowsky JP, Gordon AM, Agrawal SK. Study protocol for a randomised controlled trial to determine the efficacy of an intensive seated postural intervention delivered with robotic and rigid trunk support systems. BMJ Open. 2023 Aug 17;13(8):e073166. doi: 10.1136/bmjopen-2023-073166.
PubMed 37591642
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postural Control Intervention With the Robotic Trunk-Support-Trainer (TruST) in Children With Cerebral Palsy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04897347
- Acronym / sponsor ID
- AAAS7804
- Conditions
- Cerebral Palsy
- Keywords
- Posture, Reaching, Robotics, Motor Learning, Motor Control
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Teachers College, Columbia UniversityUniversity, hospital or other
- Collaborators
- Columbia University
- Study start
- 26 Feb 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 21 May 2021 (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 purpose of this study is to test the efficacy of a motor learning-based postural and reaching control intervention delivered with the robotic Trunk-Support-Trainer (TruST) compared to the same motor learning-based intervention delivered with Static Trunk Support Equipment in children with cerebral palsy (CP) classified as III and IV with the Gross Motor Function Classification System (GMFCS).
Detailed description
This study is a prospective Clinical Randomized Control Trial (RCT) in a group of 82 children with cerebral palsy. The experimental and control groups will receive effective postural-reaching training based on motor learning and control principles. In both groups, participants will engage in play and functional activities that elicit arm movement and challenge trunk postural control, and the motor tasks and activities will be progressed. The main difference is that the experimental group will be trained with TruST in order to add postural task-progression via assistive force fields; which will be tailored to the child's sitting control balance status across training sessions. However, in the control group, postural task-progression will be addressed by lowering the level of rigid trunk support segment by segment across training sessions. The trunk subregion where the support is placed will depend on the child's trunk control ability. Participants will be recruited from the United States.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic Trunk-Support-Trainer (TruST) | Experimental | Device: Robotic Trunk-Support-Trainer (TruST)Postural-reaching control intervention with TruST |
| Static Trunk Support | Active comparator | Device: Static Trunk SupportPostural-reaching control intervention with Rigid Trunk Support |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age 6-17 years
- Diagnosis of Bilateral CP: diplegia, triplegia, or quadriplegia
- Gross Motor Function Classification Systems-Expanded \& Review (GMFCS) levels III or IV
- Ability to sit 5s with trunk support between mid-ribs and pelvis (SATCo = 3-7)
- Cognitive capacity to follow basic verbal instructions (i.e., "do not put your hands on your lap" or "follow and reach the toy")
Key exclusion criteria (9 listed)
- Absent head control (SATCo = 1)
- Current medical illness unrelated to CP at the time of the study
- Severe dyskinesia that prevents the child from maintaining sitting and recovering balance during reaching movements
- History of recurrent seizures (daily) or drug-resistance epilepsy
- Severe Spinal Deformities: scoliosis >40◦ and/or kyphosis >45◦
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 Trunk-Support-Trainer (TruST)This will involve tailoring the level of postural assistance via force fields and systematically introduce postural task-progression across training sessions. Age-appropriate activities, including toys and games, will be used in training. - Twelve 2hr training sessions (3 times per week for 4 weeks) | Device | Robotic Trunk-Support-Trainer (TruST) |
| Static Trunk SupportThis will involve static support for the trunk via a trained therapist. Age-appropriate activities, including toys and games, will be used in training. - Twelve 2hr training sessions (3 times per week for 4 weeks) | Device | Static Trunk Support |
Primary outcome
Change in Modified Functional Reach Test (mFRT) after intervention
Time frame: Through study completion, an average of 4 months
The mFRT measures proactive postural control during maximum reaching distance. It is a valid and reliable tool in CP; and it discriminates GMFCS levels.
Change in Postural Star-Sitting Test (PSST) after intervention
Time frame: Through study completion, an average of 4 months
The PSST will be performed before and after interventions to monitor sitting control progression in both TruST- and control-intervention groups. The investigators have several motivations that rationalize this customized measurement. It: 1) is age-appropriate, 2) is goal-oriented, 3) directly measures sitting based on trunk control improvements, 4) is responsive to capture sitting workspace area increases, and 5) offers data with a straightforward functional interpretation.
Change in Box and Blocks Test (BBT) after intervention
Time frame: Through study completion, an average of 4 months
The BBT examines manual dexterity. The child moves the maximum number of blocks (2.5cm2), one at a time, between the compartments of a partitioned box within 60s. B\&B is sensitive to post-intervention changes with the more- and less-affected hand. Arm displacement and grasping will be analyzed with Datavyu. An instruction manual has been created to standardize video-coding procedures and define the reaching variables. Grasping will be defined from the moment the hand contacts the block to the time this is lifted from the surface. Arm displacement will be defined from end of grasping to block release. Reaching performance will be the summation of grasping and arm displacement. Two coders will be used to determine video-coding reliability.
6 secondary outcomes
Change in Gross Motor Function Measure-Item Set (GMFM-IS) after intervention
Time frame: Through study completion, an average of 4 months
Change in Canadian Occupational Performance Measure (COPM) after intervention
Time frame: Through study completion, an average of 4 months
Change in Participation and Environment Measure - Children and Youth (PEM-CY) after intervention
Time frame: Through study completion, an average of 4 months
Change in Seated Postural & Reaching Control (SP&R-co) after intervention
Time frame: Through study completion, an average of 4 months
Change in Postural and Reaching Kinematics after intervention
Time frame: Through study completion, an average of 4 months
Change in Segmental Assessment of Trunk Control (SATCo) after intervention
Time frame: Through study completion, an average of 4 months
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 Dec 2023.
- Derived from this study: PubMed 37591642Santamaria V, Ai X, Chin K, Dutkowsky JP, Gordon AM, Agrawal SK. Study protocol for a randomised controlled trial to determine the efficacy of an intensive seated postural intervention delivered with robotic and rigid trunk support systems. BMJ Open. 2023 Aug 17;13(8):e073166. doi: 10.1136/bmjopen-2023-073166.
- Individual participant dataSharing planned: Yes. All study data will be made available via the Data and Specimen Hub (DASH), a data sharing platform of the Eunice Kennedy Shriver National Institute of Child Health and Development.
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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.
Sunil Agrawal, PhD principal investigator
Columbia University
Andrew Gordon, PhD principal investigator
Teachers College, Columbia University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic Trunk-Support-Trainer (TruST) and Static Trunk Support in people with Cerebral Palsy, run by Teachers College, Columbia University at 2 sites 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 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: looking for participants now, as of the sponsor's last update on 22 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Victor Santamaria, PT, PhD (212.678.3332, vs2578@columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Modified Functional Reach Test (mFRT) after intervention (time frame: Through study completion, an average of 4 months). 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 NCT04897347, 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 Dec 2023.