Use of Joystick-operated Ride-on-toys to Improve Affected Arm Use and Function in Children With Hemiplegic Cerebral Palsy

The Quality of Upper Extremity Skills Test (QUEST) is a criterion-referenced, valid, and reliable measure for use between 18 months-12 years to assesses quality of UE function in 4 domains: dissociated movement, grasp, protective extension, and weight bearing. The tool includes 36 items that evaluate movement patterns and hand function in children with CP and are scored on a dichotomous scale. Scores for each sub-domain and the total score are calculated as percentages. The total QUEST score was calculated by summing scores for each sub-domain tested divided by the total number of sub-domains tested. The total scores on the QUEST range from 0 to 100. Higher scores represent better quality of movement.

Time frame: Baseline, at 6-weeks (i.e., at the end of the control phase), at 12-weeks (i.e., at the end of intervention phase)

We will provide children with the Actigraph wrist activity monitors that can be worn like a wristwatch. Children will be asked to wear 2 wrist monitors, one each on both wrists, at 6 timepoints: (a) for one week at the pretest, (b) for one week at mid-point assessment, (c) during first week of training, (d) during last week of training, and (e) for one week at posttest. Children will be provided 2 watches during the pretest visit and they will be requested to wear the watches on both wrists for the next 1 week prior to the start of the training program. Children will be asked to wear the monitor continuously when awake and while sleeping for a minimum of 4 days - 1 weekend day and 3 weekdays.

Time frame: Baseline, at 6-weeks (i.e., at the end of the control phase), at 12-weeks (i.e., at the end of intervention phase)

Data will be collected during a unilateral and bilateral reach-grasp task at self-selected speed involving different objects (foam ball, rattle, and square block) placed at half arm's length (near) and at arm's length (far) on the table. Sensors (Inertial Measurement Units (IMUs)) will be placed on both hands, both forearms, both arms, and the C7 spinous process. We will assess range of motion of joints during upper extremity activities.

Time frame: at 6-weeks (i.e., at the end of the control phase), at 12-weeks (i.e., at the end of intervention phase)

Sensors mounted on the toy will collect data on amount of use (in minutes/week) of the toy during training weeks. We will assess toy use on a weekly basis across the training period.

Time frame: From start to end of 6-week intervention phase on a weekly basis

An unbiased coder randomly coded video data (one each of early, mid, and late sessions) from researcher-delivered sessions within the intervention phase using a fidelity checklist to assess adherence to the training protocol. A 159-item fidelity checklist (total possible score: 159) specific to the training program was used for scoring treatment fidelity. Each item was rated on scale of 0 to 1, where 0 meant that the criterion was not satisfied and 1 meant that the fidelity criterion was satisfied. The total scores on the checklist could range from 0 to 159. We calculated a percent fidelity score by dividing the total score received by the total possible score (i.e., 159) and then multiplied this value by 100.

Time frame: Early (week 1), Mid (week 3), and late (week 6) training sessions within the 6-week intervention phase

The Shriner's Hospital Upper Extremity Evaluation (SHUEE) is a video-based assessment designed to assess spontaneous use and dynamic segmental alignment of the affected UE during functional tasks in children with hemiplegic CP between 3 and 18 years. The SHUEE includes 16 bimanual tasks. Of these 16 tasks, to assess the child's actual function of the affected UE a spontaneous use score is calculated during performance of 9 out of the 16 tasks. This Spontaneous Functional Analysis (SFA) score per task is rated on a scale of 0 to 5, where higher values indicate more spontaneous use of the affected UE. We summed the SFA scores across all 9 tasks, divided this sum by the total possible score, and then multiplied this value by 100 to express SFA as a percentage of normal or optimal score.

Time frame: Baseline, at 6-weeks (i.e., at the end of the control phase), at 12-weeks (i.e., at the end of intervention phase)

Trainers will fill out posttest exit questionnaires to assess ease of implementation of the training program.

Time frame: At 12 weeks (i.e. following completion of the intervention and control phases each lasting for 6 weeks)

Population: child and caregiver

Researchers will also maintain training logs during the intervention phase to document # of training sessions completed out of the total possible sessions (12).

Time frame: From start to end of 6-week intervention phase on a weekly basis

Children and caregivers will fill out exit questionnaires to assess training satisfaction, enjoyment, repeatability, and caregiver burden.

Time frame: At 12 weeks (i.e. following completion of the intervention and control phases each lasting for 6 weeks)

Children will complete the valid and reliable 16-item Physical Activity Enjoyment Scale (PAES) to rate their experience with the intervention. The PAES includes a mix of 9 positively phrased (e.g., I enjoy it, It gives me energy, etc.) and 7 negatively phrased (e.g., I feel bored, It's no fun at all, etc.) questions that are rated on a 5-point Likert scale (1: Disagree a lot, 5 - Agree a lot). The negatively coded items were reverse coded and an average total score across all items was calculated. The PAES total score ranges from 1 to 5, with higher scores indicating greater levels of enjoyment with training activities.

Time frame: At 6-weeks (i.e., at the end of the control phase), at 12 weeks (i.e. following completion of the intervention phase)

Early, mid, & late training sessions will be coded for % duration of assisted (child needs trainer-provided manual assistance) versus independent navigation.

Time frame: Early (week 1), mid (week 3), and late (week 6) training sessions within the 6-week intervention phase

Training sessions (one early, mid, and late session each) will be video-coded for child affect (i.e., smile rates, % duration of positive/interested and negative affect)

Time frame: Early (week 1), mid (week 3), and late (week 6) sessions during the 6-week intervention phase

Training sessions (one early, mid, and late session each) will be video-coded for attention (i.e., % duration of attention to task-relevant targets).

Time frame: Early (week 1), mid (week 3), and late (week 6) sessions during the 6-week intervention phase

The ABILHAND-Kids is a valid and reliable parent-rated questionnaire assessing parent perceptions of their child's level of ease or difficulty in performing 21 manual activities independently over the last 3 months. The questionnaire has been validated as a measure of manual ability for 6-16-year-old children with CP. The 21 manual activities are rated by parents on a 3-point scale of impossible (given a score of 0), difficult (given a score of 1), or easy (given a score of 2). ABILHAND score is expressed in logits, resulting from the conversion of the ordinal raw score into a linear measure of ability located on a unidimensional scale. The logit is a linear unit that expresses the odds of success of the patient on any given item. This unit is constant throughout the measurement scale. The manual ability scale is, by convention, centered on the average item difficulty (0 logit), the scale ranging from -6.75 to 6.68, with higher scores indicating better manual abilities.

Time frame: Baseline, at 6-weeks (i.e., at the end of the control phase), at 12-weeks (i.e., at the end of intervention phase)

The path navigation test will be coded for the number of times the child bumps/crashes against obstacles during the navigation. We will report on the number of such bumps/crashes per minute of navigation time. Higher values of this variable indicate worse performance (poor navigational control).

Time frame: Baseline, at 6-weeks (i.e., at the end of the control phase), at 12-weeks (i.e., at the end of intervention phase)

The path navigation test will involve children navigating through paths that are clearly demarcated using tape/chalk. We counted the number of times per minute that children went outside the demarcated path during the navigation test. Higher values of this variable indicate worse performance (poor navigational control).

Time frame: Baseline, at 6-weeks (i.e., at the end of the control phase), at 12-weeks (i.e., at the end of intervention phase)

The path navigation test will be coded for the average duration of child-initiated, movement bouts normalized by driving time (a bout comprises 1 acceleration and 1 deceleration phase).

Time frame: Baseline, at 6-weeks (i.e., at the end of the control phase), at 12-weeks (i.e., at the end of intervention phase)