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Robotic TruST-Postural Intervention for Children With Cerebral Palsy

Primary Purpose

Cerebral Palsy

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Robotic Trunk-Support-Trainer (TruST)
Static Trunk Support
Sponsored by
Teachers College, Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring Posture, Reaching, Robotics, Motor Learning, Motor Control

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Columbia UniversityRecruiting
  • Teachers College, Columbia UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Robotic Trunk-Support-Trainer (TruST)

Static Trunk Support

Arm Description

Postural-reaching control intervention with TruST

Postural-reaching control intervention with Rigid Trunk Support

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
May 12, 2021
Last Updated
October 26, 2022
Sponsor
Teachers College, Columbia University
Collaborators
Columbia University
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1. Study Identification

Unique Protocol Identification Number
NCT04897347
Brief Title
Robotic TruST-Postural Intervention for Children With Cerebral Palsy
Official Title
Postural Control Intervention With the Robotic Trunk-Support-Trainer (TruST) in Children With Cerebral Palsy: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 26, 2022 (Actual)
Primary Completion Date
December 2026 (Anticipated)
Study Completion Date
June 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Teachers College, Columbia University
Collaborators
Columbia University

4. Oversight

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

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
Posture, Reaching, Robotics, Motor Learning, Motor Control

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
82 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Robotic Trunk-Support-Trainer (TruST)
Arm Type
Experimental
Arm Description
Postural-reaching control intervention with TruST
Arm Title
Static Trunk Support
Arm Type
Active Comparator
Arm Description
Postural-reaching control intervention with Rigid Trunk Support
Intervention Type
Device
Intervention Name(s)
Robotic Trunk-Support-Trainer (TruST)
Intervention Description
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)
Intervention Type
Device
Intervention Name(s)
Static Trunk Support
Intervention Description
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)
Primary Outcome Measure Information:
Title
Change in Modified Functional Reach Test (mFRT) after intervention
Description
The mFRT measures proactive postural control during maximum reaching distance. It is a valid and reliable tool in CP; and it discriminates GMFCS levels.
Time Frame
Through study completion, an average of 4 months
Title
Change in Postural Star-Sitting Test (PSST) after intervention
Description
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.
Time Frame
Through study completion, an average of 4 months
Title
Change in Box and Blocks Test (BBT) after intervention
Description
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.
Time Frame
Through study completion, an average of 4 months
Secondary Outcome Measure Information:
Title
Change in Gross Motor Function Measure-Item Set (GMFM-IS) after intervention
Description
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.
Time Frame
Through study completion, an average of 4 months
Title
Change in Canadian Occupational Performance Measure (COPM) after intervention
Description
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.
Time Frame
Through study completion, an average of 4 months
Title
Change in Participation and Environment Measure - Children and Youth (PEM-CY) after intervention
Description
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.
Time Frame
Through study completion, an average of 4 months
Title
Change in Seated Postural & Reaching Control (SP&R-co) after intervention
Description
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.
Time Frame
Through study completion, an average of 4 months
Title
Change in Postural and Reaching Kinematics after intervention
Description
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.
Time Frame
Through study completion, an average of 4 months
Title
Change in Segmental Assessment of Trunk Control (SATCo) after intervention
Description
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.
Time Frame
Through study completion, an average of 4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Victor Santamaria, PT, PhD
Phone
212.678.3332
Email
vs2578@columbia.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Karen Chin, MA
Phone
212.678.3332
Email
cpresearch@tc.columbia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sunil Agrawal, PhD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrew Gordon, PhD
Organizational Affiliation
Teachers College, Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10027
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victor Santamaria, PT, PhD
Phone
212-678-3332
Email
vs2578@columbia.edu
Facility Name
Teachers College, Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10027
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen Chin, MA
Phone
212-678-3332
Email
cpresearch@tc.columbia.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Time Frame
Data will be made available upon completion of data collection.
IPD Sharing Access Criteria
Data will be provided upon request.

Learn more about this trial

Robotic TruST-Postural Intervention for Children With Cerebral Palsy

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