Robotic TruST-Postural Intervention for Children With Cerebral Palsy

• ClinicalTrials.gov Identifier: NCT04897347
• Recruitment Status: Recruiting
• First Posted: May 21, 2021
• Last Update Posted: December 22, 2023
• Sponsor: Teachers College, Columbia University
• Collaborator: Columbia University
• Information provided by (Responsible Party): Teachers College, Columbia University

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Cerebral Palsy	Device: Robotic Trunk-Support-Trainer (TruST); Device: Static Trunk Support	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 82 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Postural Control Intervention With the Robotic Trunk-Support-Trainer (TruST) in Children With Cerebral Palsy: A Randomized Controlled Trial
• Actual Study Start Date: February 26, 2022
• Estimated Primary Completion Date: December 2026
• Estimated Study Completion Date: June 2027

Arms and Interventions

Arm	Intervention/treatment
Experimental: Robotic Trunk-Support-Trainer (TruST); Postural-reaching control intervention with TruST	Device: 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)
Active Comparator: Static Trunk Support; Postural-reaching control intervention with Rigid Trunk Support	Device: Static 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)

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.
3. 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.

Secondary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.

Eligibility Criteria

• Ages Eligible for Study: 6 Years to 17 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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)

Contacts and Locations

Contacts

Contact: Victor Santamaria, PT, PhD; 212.678.3332; vs2578@columbia.edu

Contact: Karen Chin, MA; 212.678.3332; cpresearch@tc.columbia.edu

Locations

United States, New York

Columbia University; Recruiting

New York, New York, United States, 10027

Contact: Victor Santamaria, PT, PhD 212-678-3332 vs2578@columbia.edu

Teachers College, Columbia University; Recruiting

New York, New York, United States, 10027

Contact: Karen Chin, MA 212-678-3332 cpresearch@tc.columbia.edu

Sponsors and Collaborators

Teachers College, Columbia University

Columbia University

Investigators

• Principal Investigator: Sunil Agrawal, PhD; Columbia University
• Principal Investigator: Andrew Gordon, PhD; Teachers College, Columbia University

  Study Documents (Full-Text)

Documents provided by Teachers College, Columbia University:

Statistical Analysis Plan  [PDF] May 10, 2021

Informed Consent Form  [PDF] December 9, 2020

More Information

• Responsible Party: Teachers College, Columbia University
• ClinicalTrials.gov Identifier: NCT04897347
• Other Study ID Numbers: AAAS7804; 1R01HD101903-01 ( U.S. NIH Grant/Contract )
• First Posted: May 21, 2021
• Last Update Posted: December 22, 2023
• Last Verified: December 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: 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.
• Supporting Materials: Statistical Analysis Plan (SAP)
• Time Frame: Data will be made available upon completion of data collection.
• Access Criteria: Data will be provided upon request.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Teachers College, Columbia University:

Posture; Reaching; Robotics; Motor Learning; Motor Control

Additional relevant MeSH terms:

Cerebral Palsy; Nervous System Diseases; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases