TiDiER checklist for comparison between TruST intervention and static trunk support interventions
| Name | Trunk-Support-Trainer-intervention (experimental) | Static Trunk-Support-intervention (control) |
| Why | Motor learning principles and motor-task progression implemented. Postural task progression is objectively tailored to the child’s sitting balance status and systematically progressed in each training session. | The therapeutic elements and intervention protocol are the same. However, the postural task progression is implemented by lowering the static trunk support as the child improves in segmental trunk control stability across sessions. |
| What: equipment | Toys, balloons, balls, cups, blocks, board games, buzzers, white board and coloured pens. A bench with adjustable height and straps to support the pelvis is fixed to a mechanical lifter. The robotic TruST dynamically controls the trunk in sitting; and thus, the entire upper body moves within the pre-defined sitting stability boundaries. | Same equipment and bench. However, the bench is integrated with a rigid apparatus to adjust the level of support at the specific sub-region of the torso where the child loses sitting balance control. Thus, only the upper body region above the rigid support can freely move during the motor intervention. |
| What: procedures | Age-appropriate discrete, serial, and continuous motor tasks, including: reaching (pointing and grasping with whole hand and fingers), catching, throwing, punching, tapping, and lifting. Motor activities will be practised along eight star-radiated directions that are approximately spaced 45° apart and have their centre at the child’s pelvis. Motor practice will be within and beyond reaching distance in each one of the eight directions covering the full child’s peripersonal space (360°). A total of 30–50 repetitions will be trained in a clockwise and counterclockwise fashion to train the more-impaired and less-impaired upper limbs. | Same intervention structure and procedures. |
| Providers | Two researchers with clinical/kinesiology knowledge and a bioengineer will participate in each session. The assignment of the personnel providing the intervention will be counterbalanced. | Same providers and counterbalance design. |
| How | A one-on-one intervention delivery. Motor learning-based intervention that is task-oriented (predefined motor goal), age-appropriate (engaging practice), intensive mass practice (training>resting and high number of trials and performance over time), sequential skill progression (part-task training) and motor randomisation (variability during task practice). Motor control parameters modulated to challenge motor performance. TruST provides visual feedback on a screen to guide the clinician to train two distances: ‘within boundaries’ (maximum active reaching distance) and ‘beyond boundaries’ (beyond active reaching distance). TruST-force fields assist the child in performing postural trunk movements. | Same therapeutic programme, clinical delivery and motor learning and control principles will be applied. The motor tasks are equally practised at two distances: ‘within maximum active reaching distance’ and ‘beyond active reaching distance’. The rigid trunk support system assists the postural trunk movements by statically holding the sub-region of the child’s torso where the loss of sitting balance is found. |
| Where | Laboratory setting | Same setting |
| When and how much: a) intensity, b) frequency, c) session time, d) overall duration | The training dosage and schedule will be 2 hour sessions, 3x/week, over 4 weeks, with an estimated overall duration of 24 hours of training. | Same intervention schedule and dosage. |
| Tailoring | Postural task progression will be implemented via assist-as-needed force fields that are equivalent to 10% of the child’s body weight. These force fields will be determined by the area and boundaries of stable sitting control measured by a customised postural star-sitting test (ie, a trunk control-based kinematic measurement). Force fields are re-adjusted at the beginning of each training session to maintain the postural and motor challenge at a maximum level during the motor intervention. | The static support will be placed at the trunk region at which the child loses sitting balance, as determined by the SATCo. Postural task progression will be implemented by lowering the rigid support, as the child acquires greater trunk control. The SATCo, starting at the most-impaired trunk segment, will be systematically used prior to each intervention session to re-adjust the support system and ensure maximum postural challenge during the motor intervention. |
| Modifications | Games and motor activities will be selected based on the child’s preferences. Otherwise, no modifications are expected to occur. | Same method for the selection of games and motor activities. |
| How well: planned a) fidelity strategies b) fidelity assessment | Videos and logs will be used to monitor (i) study attendance, (ii) VAS for discomfort/pain (Wong-Baker FACES),66 (iii) perceived physical exertion (OMNI),25 (iv) motor control parameters used and modulated during training. Video-coding of training sessions to determine effectiveness of training (ie, active movements without considering breaks, training setup features, time to transfer between motor activities, breaks such as toilet use), type of motor activity and practice time, and motor capacity (eg, successful trials). | Same procedure to monitor study attendance, child’s discomfort/pain, physical exertion, and motor learning/control modulation for ensuring intervention fidelity. |
| How well: actual | We will determine whether the study and intervention plans are achieved based on attendance to measure participation, data from the customised postural star-sitting test (ie, increases in assistive force fields boundaries and improved sitting workspace area), and video-coding data to measure motor capacity. The presence of unexpected accidents or therapeutic adverse effects together with the level of fatigue and discomfort or pain will determine intervention safety and feasibility in a large scale of children with BCP. | Similarly, we will determine whether the study and intervention plans are achieved based on attendance to measure participation, data from the SATCo across sessions to determine enhanced postural trunk control, and video-coding data about the type of motor activity to study improved motor capacity. The presence of unexpected accidents or therapeutic adverse effects together with the level of fatigue and discomfort or pain will inform on intervention safety and feasibility in a large scale of children with BCP. |
BCP, bilateral cerebral palsy; OMNI, OMNI Picture System for rating of perceived exertion; SATCo, Segmental Assessment of Trunk Control; TruST, Trunk-Support-Trainer.