- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04897347
Robotic TruST-Postural Intervention for Children With Cerebral Palsy
Postural Control Intervention With the Robotic Trunk-Support-Trainer (TruST) in Children With Cerebral Palsy: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Victor Santamaria, PT, PhD
- Phone Number: 212.678.3332
- Email: vs2578@columbia.edu
Study Contact Backup
- Name: Karen Chin, MA
- Phone Number: 212.678.3332
- Email: cpresearch@tc.columbia.edu
Study Locations
-
-
New York
-
New York, New York, United States, 10027
- Recruiting
- Columbia University
-
Contact:
- Victor Santamaria, PT, PhD
- Phone Number: 212-678-3332
- Email: vs2578@columbia.edu
-
New York, New York, United States, 10027
- Recruiting
- Teachers College, Columbia University
-
Contact:
- Karen Chin, MA
- Phone Number: 212-678-3332
- Email: cpresearch@tc.columbia.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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")
Exclusion Criteria:
- 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
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Robotic Trunk-Support-Trainer (TruST)
Postural-reaching control intervention with 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) |
Active Comparator: Static Trunk Support
Postural-reaching control intervention with Rigid Trunk Support
|
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) |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Through study completion, an average of 4 months
|
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.
|
Through study completion, an average of 4 months
|
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.
|
Through study completion, an average of 4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Gross Motor Function Measure-Item Set (GMFM-IS) after intervention
Time Frame: Through study completion, an average of 4 months
|
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.
|
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
|
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.
|
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
|
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.
|
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
|
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.
|
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
|
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.
|
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
|
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.
|
Through study completion, an average of 4 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Sunil Agrawal, PhD, Columbia University
- Principal Investigator: Andrew Gordon, PhD, Teachers College, Columbia University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAAS7804
- 1R01HD101903-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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