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
2 other identifiers
interventional
82
1 country
2
Brief 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) classified as III and IV with the Gross Motor Function Classification System (GMFCS).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2022
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 12, 2021
CompletedFirst Posted
Study publicly available on registry
May 21, 2021
CompletedStudy Start
First participant enrolled
February 26, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2027
December 22, 2023
December 1, 2023
4.8 years
May 12, 2021
December 21, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
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.
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.
Through study completion, an average of 4 months
Secondary Outcomes (6)
Change in Gross Motor Function Measure-Item Set (GMFM-IS) after intervention
Through study completion, an average of 4 months
Change in Canadian Occupational Performance Measure (COPM) after intervention
Through study completion, an average of 4 months
Change in Participation and Environment Measure - Children and Youth (PEM-CY) after intervention
Through study completion, an average of 4 months
Change in Seated Postural & Reaching Control (SP&R-co) after intervention
Through study completion, an average of 4 months
Change in Postural and Reaching Kinematics after intervention
Through study completion, an average of 4 months
- +1 more secondary outcomes
Study Arms (2)
Robotic Trunk-Support-Trainer (TruST)
EXPERIMENTALPostural-reaching control intervention with TruST
Static Trunk Support
ACTIVE COMPARATORPostural-reaching control intervention with Rigid Trunk Support
Interventions
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)
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)
Eligibility Criteria
You may qualify if:
- 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")
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Teachers College, Columbia Universitylead
- Columbia Universitycollaborator
Study Sites (2)
Columbia University
New York, New York, 10027, United States
Teachers College, Columbia University
New York, New York, 10027, United States
Related Publications (1)
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.
PMID: 37591642DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sunil Agrawal, PhD
Columbia University
- PRINCIPAL INVESTIGATOR
Andrew Gordon, PhD
Teachers College, Columbia University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 12, 2021
First Posted
May 21, 2021
Study Start
February 26, 2022
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
June 1, 2027
Last Updated
December 22, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- SAP
- Time Frame
- Data will be made available upon completion of data collection.
- Access Criteria
- Data will be provided upon request.
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.