Robotic TruST-Postural Intervention for Children With Cerebral Palsy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-17
SponsorTeachers College, Columbia University

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Robotic Trunk-Support-Trainer (TruST)

    Device

    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)

  • Static Trunk Support

    Device

    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)

Treatment groups

82 Participants
are divided into 2 treatment groups
Group A: Robotic Trunk-Support-Trainer (TruST)Experimental treatment 1 intervention
Group B: Static Trunk SupportActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Through study completion, an average of 4 months
2

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.

Time frame
Through study completion, an average of 4 months
3

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.

Time frame
Through study completion, an average of 4 months

Secondary outcomes

1

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.

Time frame
Through study completion, an average of 4 months
2

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.

Time frame
Through study completion, an average of 4 months
3

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.

Time frame
Through study completion, an average of 4 months
4

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.

Time frame
Through study completion, an average of 4 months

Other outcomes

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