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

Not Applicable

Completed

Conditions: Hemiplegic Cerebral Palsy

Registration Number: NCT05559320

Lead Sponsor: University of Connecticut

Brief Summary: This research is being done to explore if modified, commercially available, joystick-operated, ride-on-cars can be used to promote bilateral arm function in children with hemiplegic Cerebral Palsy (CP). Specifically, the study evaluates the effects of a 6-week, home-based, child-friendly, innovative program that uses modified, commercially available, joystick-operated, powered ride-on-toys to promote spontaneous affected arm use and function in children with hemiplegic CP.

Detailed Description: Prior to the start of the study, researchers will conduct a phone screening with the family to confirm their child's eligibility to participate in the study. Once eligibility is confirmed, during the pretest session, standardized assessments will be conducted to evaluate the child's ability to use their affected arm for different functional activities. During this testing visit, researchers will also use small sensors on the child's arms and observe their movements as they complete a reaching task. In addition, caregivers will be asked to complete questionnaires to obtain information on their child's overall health, development, and their ability to use their affected arm for various activities of daily living.

Assessments and questionnaires will be repeated again at the mid-point of the study (that corresponds with completion of the 6-week control phase), and at posttest (that corresponds with completion of the 6-week home-based intervention phase). Researchers will video record all testing and training sessions so that children's performance can be scored later. Children will also be asked to wear wrist monitors on both hands to assess their habitual activity levels on dominant and non-dominant arms for 1 week at the pretest, at the mid-point assessment, during the first and last weeks of the training, and at posttest.

This study consists of 2 phases: the control phase and the intervention phase. During the first 6-week control phase, the researchers will contact families on a weekly basis to obtain information regarding different therapies that their child receives both in and out of school. In the next 6-week intervention phase, researchers will visit the child's home twice a week to provide a training program involving joystick-operated ride-on-toys that will encourage the child to use their affected arm to control and navigate the ride-on-car through their physical environment. During the intervention phase the ride-on-car will be left at the child's home so that children can practice driving the car under caregiver supervision for additional days during the week. All testing sessions will be conducted before and after the control and intervention phases of the study.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 15

Inclusion Criteria

Are boys or girls between the ages of 3 - 8 years
Have been diagnosed with hemiplegic Cerebral palsy by a medical doctor with clear asymmetry in upper extremity strength and control, i.e., one upper limb is clearly weaker than the other;
Have had no physical trauma (including surgery) in the past 6 months;
Demonstrate awareness of objects in their environment through their visual system;
Can use their upper extremity or trunk to activate a joystick placed within reachable distance;
Can maintain a supported sitting position for at least 20 minutes

Exclusion Criteria

Have only lower limb involvement
Are capable of using both hands together very well for functional activities;
Age >8 years or below 3 years of age
Exceed safe weight or height limits of the device;
Have parents who know at the time of the initial contact that they will not be able to complete training and all the posttest sessions

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in Affected Arm Movement Control	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 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.
Changes in Use of Affected Arm in Functional Activities	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 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.
Changes in Habitual Arm Activity on the Affected Side	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.
Treatment Satisfaction	At 6-weeks (i.e., at the end of the control phase), at 12 weeks (i.e. following completion of the intervention phase)	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.
Perceived Satisfaction With Intervention	At 12 weeks (i.e. following completion of the intervention and control phases each lasting for 6 weeks)	Children and caregivers will fill out exit questionnaires to assess training satisfaction, enjoyment, repeatability, and caregiver burden.
Ease of Implementation of Training	At 12 weeks (i.e. following completion of the intervention and control phases each lasting for 6 weeks)	Trainers will fill out posttest exit questionnaires to assess ease of implementation of the training program.
Changes in Treatment Fidelity Across Training Weeks	Early (week 1), Mid (week 3), and late (week 6) training sessions within the 6-week intervention phase	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.
Changes in Toy Use (in Minutes/Week) Across Training Weeks	From start to end of 6-week intervention phase on a weekly basis	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.
# of Training Sessions Completed Assessed Using Training Logs	From start to end of 6-week intervention phase on a weekly basis	Researchers will also maintain training logs during the intervention phase to document # of training sessions completed out of the total possible sessions (12).
Changes in Kinematic Measures of Movement Control on the Affected Arm	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.

Secondary Outcome Measures

Name	Time	Method
Changes in Child Attention During Training Sessions	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).
Changes in Child Affect Across Training Sessions	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 child affect (i.e., smile rates, % duration of positive/interested and negative affect)
Changes in the Duration of Movement Bouts During Navigation Across Testing Sessions	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).
Changes in Parent-rated Scores on Functional Use of the Affected Arm	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 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.
Changes in Amount of Trainer Assistance Needed During Navigation	Early (week 1), mid (week 3), and late (week 6) training sessions within the 6-week intervention phase	Early, mid, \& late training sessions will be coded for % duration of assisted (child needs trainer-provided manual assistance) versus independent navigation.
Changes in Rates of Obstacle Contacts Across Testing Sessions	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).
Changes in Rates of Path Deviations Across Testing Sessions	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).

Trial Locations

Locations (1): Physical Therapy Program, Department of Kinesiology, University of Connecticut
🇺🇸
Storrs, Connecticut, United States
Physical Therapy Program, Department of Kinesiology, University of Connecticut
🇺🇸Storrs, Connecticut, United States