Robotic TruST-Postural Intervention for Children With Cerebral Palsy

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ClinicalTrials.gov Identifier: NCT04897347

Recruitment Status : Recruiting

First Posted : May 21, 2021

Last Update Posted : December 22, 2023

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Sponsor:

Collaborator:

Columbia University

Information provided by (Responsible Party):

Teachers College, Columbia University

Tracking Information

First Submitted Date ^ICMJE

May 12, 2021

First Posted Date ^ICMJE

May 21, 2021

Last Update Posted Date

December 22, 2023

Actual Study Start Date ^ICMJE

February 26, 2022

Estimated Primary Completion Date

December 2026 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Change in Modified Functional Reach Test (mFRT) after intervention [ Time Frame: Through study completion, an average of 4 months ]
This is a clinically validated test in CP that measures proactive postural control during maximal reaching distance. It takes into account motor planning and unidirectional control of the trunk in the sagittal/frontal planes during the reach in sitting.
Change in Postural Star-Sitting Test (PSST) after intervention [ Time Frame: Through study completion, an average of 4 months ]
This postural assessment will be performed prior to and after training sessions to monitor sitting control progression in both TruST- and control-intervention groups. In sitting, the child performs eight star-shaped maximal trunk displacements while displacing a large ball with the head. We have several motivations that rationalize this customized measurement: 1) it is age-appropriate, 2) it is goal-oriented, 3) it directly measures sitting based on trunk control improvements, 4) it is sensitive to capture symmetrical and asymmetrical increases in the sitting workspace area (cm2), and 5) it 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 B&B is a validated test in CP to examine manual dexterity. The child moves the maximum number of blocks (2.5cm2), one at a time, between compartments of a partitioned box within. Video-coding of reaching performance (arm displacement and grasping) during the B&B will be analyzed with Datavyu. A manual will be created to define the reaching variables and to standardize video-coding procedures. Grasping will be defined as the time window from the moment the hand contacts the block to the time this is lifted from the surface. Arm displacement will be defined as the time to transport the block (from end of grasping to its release). Reaching performance will be the summation of grasping and arm displacement. Two coders will be used to determine inter-rater reliability between video-coders.

Change History

Current Secondary Outcome Measures ^ICMJE

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.
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.
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.
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.
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.
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.

Original Secondary Outcome Measures ^ICMJE

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. It is an abbreviated and validated version of the GMFM-66, which provides information on the level of difficulty of each item to define motor goals to attain. It uses an algorithm with three critical decision items to determine which one of the four items sets is most appropriate for a child's level of functioning. Similarly to the GMFM-66, the GMFM-IS scores gross motor function across five dimensions (A: lying and rolling, B: sitting, C: crawling, D: standing and E: walking, running & jumping).
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 upper extremities abilities that restrict participation.
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 measure participation-home, school and community-including environmental factors.
Change in Seated Postural & Reaching Control (SP&R-co) after intervention [ Time Frame: Through study completion, an average of 4 months ]
The SP&R-co has been validated in children with CP, and it mainly targets children with moderate-to-severe CP within a play-oriented framework. The test framework is built upon principles of postural control and falls under the definition of "body function and body structure" category of the International Classification of Functioning, Disability and Health: children and youth version. The SP&R-co has been constructed following a segment-by-segment approach, as the one found in the SATCo, to assess quantitatively postural sitting control across static, active, proactive via bimanual and unimanual reaches, and reactive dimensions.
Change in Postural and Reaching Kinematics after intervention [ Time Frame: Through study completion, an average of 4 months ]
Kinematics data collections will follow the postural framework validated in the Seated Postural & Reaching Control (SP&R-co) test to capture the potential motor improvements in the postural and reaching control capabilities of children. We will measure: Static Seated Task: Postural orientation and balance during sitting for 10s. Active Seated Task: The simultaneous control steady trunk position during head rotations when the child follows an object 90degrees to the right and left. Proactive Seated Task: Optimal postural sitting control via anticipatory and compensatory postural adjustments (APAs and CPAs, respectively) when children execute direction-specific reaches straight and 45degrees right and left.
Change in Segmental Assessment of Trunk Control (SATCo) after intervention [ Time Frame: Through study completion, an average of 4 months ]
The SATCo is a clinical tool validated in children with CP. With the SATCo, the evaluator offers support at 7 different trunk segments (shoulders, axillae, inferior angle of scapulae, on lower ribs, below lower ribs, and pelvis). It measures segmental trunk control across 3 dimensions: static-during 5s-proactive-visually following an object-and reactive postural responses to external nudges. The scores are from 0 (no head control) to 7 (full trunk control) and identify the trunk segment where the child loses trunk balance control-when one, or more, postural dimension is absent.

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

Robotic TruST-Postural Intervention for Children With Cerebral Palsy

Official Title ^ICMJE

Postural Control Intervention With the Robotic Trunk-Support-Trainer (TruST) in Children With Cerebral Palsy: A Randomized Controlled Trial

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).

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 Type ^ICMJE

Interventional

Study Phase ^ICMJE

Not Applicable

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Cerebral Palsy

Intervention ^ICMJE

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)
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)

Study Arms ^ICMJE

Experimental: Robotic Trunk-Support-Trainer (TruST)
Postural-reaching control intervention with TruST

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

Intervention: Device: Static Trunk Support

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date ^ICMJE

June 2027

Estimated Primary Completion Date

December 2026 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

6 Years to 17 Years (Child)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact: Victor Santamaria, PT, PhD	212.678.3332	vs2578@columbia.edu
Contact: Karen Chin, MA	212.678.3332	cpresearch@tc.columbia.edu

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT04897347

Other Study ID Numbers ^ICMJE

AAAS7804
1R01HD101903-01 ( U.S. NIH Grant/Contract )

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

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

IPD Sharing Statement ^ICMJE

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.