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Table 2 TIDieR Guidelines comparing experimental and control interventions

From: Discovering the sense of touch: protocol for a randomised controlled trial examining the efficacy of a somatosensory discrimination intervention for children with hemiplegic cerebral palsy

Item

Experimental intervention

Control intervention

Name

Sense© for Kids

Goal Directed Training via a Home Program

Why

Rationale: The ability to gain a sense of touch and use this information in goal-directed use of the arm and daily activities is supported by theories of perceptual learning and neural plasticity and may be enhanced by addressing somatosensory discrimination functions through intervention [36, 61]. Sense© for Kids is a structured and graded intervention program based on Sense© somatosensory discrimination training [36].

Theory: Underlying principles of Sense©

 • Principles of perceptual learning and learning-dependent neural plasticity inform Sense© training principles. Sense© is based on seven principles [43], with the theory underlying three core principles outlined. Goal directed attention and deliberate anticipation are important for learning and to facilitate links to somatosensory regions of the brain. Calibration across and within modality improve and create new somatosensory neural connections. Graded progression within and across sensory attributes and tasks are used to facilitate perceptual learning and transfer to novel stimuli [61].

Sense© Essential Elements: as applied to children with cerebral palsy:

 • Active exploration without vision of new and known stimuli where the child explores objects/textures/body positions with focus on discriminating differences.

 • Anticipation is used for previously experienced stimuli; the child knows what to expect to feel and concentrates on attributes of difference without vision.

 • Calibration occurs within and across modalities with comparison of what is felt by the impaired hand with the less affected hand and with vision. The child matches what they know from visual confirmation and calibration with the less affected hand with their impaired hand. They are prompted to imagine what the sensory stimulus is supposed to feel like based on this knowledge.

 • Each level of stimulus difference is trained to an accuracy level of 75% correct responses before progressing to a more difficult level of difference.

 • Transfer to untrained tasks is facilitated by training on a large variety of stimuli and integrating training principles into occupational tasks important the child. Occupational tasks are trained using grading of stimuli, feedback on distinctive features of difference and method of exploration. Additional information can be found in SENSe: A Manual for Therapists [42].

Rationale: Children with CP learn movements best when they are engaged in practicing real-life activities that are meaningful to them, based on self-identified goals and practice occurs in real-life environments.

Theory: Underlying principles of Goal Directed Training

 ▪ Dynamic systems theories of motor control, where movement emerges as a result of the interaction between the person’s abilities, the environment and their goal inform Goal Directed Training.

Underlying principles of Home Programs

 ▪ The therapist coaches caregiver and child to build confidence and capabilities

 ▪ The child and parents are more motivated by self-set goals

 ▪ Programs set up in the home environment are ecologically valid

 ▪ Practice is embedded in family routine to permit opportunity for functional practice

 ▪ Practice of a skill evolves based on performance

Goal Directed Training Essential Elements:

 ▪ Caregiver and child set goals about real-life activities the child wants or needs to perform and determines with the therapist which are realistic for intervention.

 ▪ Examination of the goal-limiting factors at the child, task and environment level.

 ▪ Changing the task and environment to facilitate child-active independence task performance.

 ▪ Establishment of a child-active motor practice schedule based on current motor performance, including intense repetition, variation and structured feedback.

Home Program Essential Elements:

 ▪ Development of a collaborative partnership characterised by empowerment of parents

 ▪ Therapist takes on a coaching role in partnership with the parent as the expert in their unique context

 ▪ Goals are set by the child and parent

 ▪ A menu of tasks to practice using Goal Directed Training principles are provided to support home practice

 ▪ Therapists actively support implementation to ensure the program continues to meet family needs and help identify successes [62].

Materials

Therapist: The Sense© training kit will be required to train the individual components of sensation. Materials for practice relating to occupational goals will vary depending on the child’s goal e.g. If the goal is using a knife and fork, food items with varying textures will be required that provide the right level of difference of somatosensory feedback during cutlery use.

A log book will be provided to all families as a reminder to complete home practice incorporating Sense© principles into child’s goals, and as an opportunity to increase the challenge as the child improves.

Materials for each child will vary depending on the child’s goal and which elements of the task and environment are being changed to enhance independent performance e.g. If the goal is catching a tennis ball, materials required may initially include balloons and then light large balls as task modifications to facilitate catching practice at the “just right challenge”.

A log book will be provided to all families as a reminder to practice, and as an opportunity to update the home program as the child improves.

Who

CHILD: Sets functional goals with a clear somatosensory demand in partnership with caregiver if appropriate.

THERAPIST: Identifies deficit in somatosensory function and works with child through component training in relevant domains (body position sense, haptic object recognition, tactile discrimination). Supports parent with incorporating Sense© principles into child’s goals.

PARENT: Incorporates Sense© principles into child’s goal.

CHILD: Sets functional goals in partnership with caregiver if appropriate.

THERAPIST: Determines goal limiting factors and partners with the parent to develop a home-based practice schedule. Also offers coaching and support via home visits

PARENT: Carries out the intervention with the child.

How

Home based

Home based

How much

The total dose of Sense© for kids will be three hours per week for six weeks with a home visit from a therapist for two hours a week and the family undertaking the remaining one hour of incorporating Sense© principles into goal practice. (same dose)

The total dose of this intervention will be three hours per week for six weeks with a home visit from a therapist one hour a week and the family undertaking the remaining accumulative two hours per week of practice. (same dose)

Tailoring

Because children will set their own goals, the activities pertaining to the goal itself may differ but in all other aspects this intervention will remain the same for all participants.

Because children will set their own goals, the activities pertaining to the goal itself may differ but in all other aspects this intervention will remain the same for all participants.

How well

This study will seek to define and measure fidelity of the Sense© for Kids intervention for:

 • Clinician adherence to active ingredients

 • Intervention receipt

There is a home program component of Sense© for Kids training which focuses on incorporating somatosensory cues into occupational task performance and the facilitation of goal attainment by utilising these somatosensory cues within tasks.

This study will seek to define and measure fidelity of Goal Directed Therapy via Home Programs for:

 • Clinician adherence to active ingredients

 • Intervention receipt

It is acknowledged that children receiving home programs will have incidental exposure to sensory stimuli through movement and interaction with objects during purposeful activity, however these stimuli will not be emphasised nor will the process of making sense of these somatosensory stimuli.