A Novel Program Using Ride-on Toys to Improve Upper Extremity Function in Children With Hemiplegia
- Conditions
- HemiplegiaCerebral PalsyChildren, Only
- Interventions
- Device: SPEED TrainingBehavioral: CRAFT Training
- Registration Number
- NCT06579027
- Lead Sponsor
- University of Connecticut
- Brief Summary
The purpose of this study is to assess the feasibility and utility of 2 types of play-based training programs co-delivered by researchers and caregivers within home/community settings to promote arm function among 3-to-8-year-old children with hemiplegia. Specifically, investigators will assess the feasibility of implementation and acceptance/satisfaction associated with a researcher-caregiver co-delivered community-based training program involving either joystick-operated powered ride-on toys (SPEED training) or creative upper extremity training (CRAFT training).
The investigators will also compare the effects of these 2 types of training programs on children's arm motor function and spontaneous use of their affected arm during daily activities.
- 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 (week 1), 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 attach small sensors on the child's arms and ask them to complete arm movements and functional tasks (e.g., lifting blocks and putting them into a small cup). At the pretest, the child will also be provided 2 activity monitors (similar to wrist watches) to wear on both wrists for 1 week. The activity monitors will allow the researchers to track the child's habitual arm activity over the duration of a week. 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 posttest (i.e., at week 8 that corresponds with completion of the 6-week intervention phase) and at 1-month follow-up following intervention completion (i.e., week 12).
Following the pretest, the child will be randomized into one of the training groups (SPEED or CRAFT). During the 6-week intervention phase, the research team will visit the child's home/community 2 times/week to provide the training. Caregivers will be requested to practice 2 additional sessions every week with their child in both groups.
Children in the Strength and Power in upper Extremities through Exploratory Driving (SPEED) training group will engage in multidirectional navigation games and object-based upper extremity quests using the ride-on toys. The toy will be modified to enable operation in a single joystick control mode with the joystick control provided on the child's affected side. The training activities will be designed to encourage children to use their affected arm for training activities. The training will involve children driving through incrementally challenging courses/paths and completing object-based tasks that require use of their affected arm for reaching, grasping, release, and fine manipulation activities. Children will be asked to wear a mitten on their unaffected hand during the sessions. Children in the Creative Rehabilitation for Arm Functional Training (CRAFT) group will engage in seated creative motor games that will encourage use of their affected arm. Training activities will involve stretching and strengthening exercises, building activities (e.g., using Play-doh, blocks, etc.), and art-craft projects, all of which will require the skillful use of the affected arm for reach, grasp, release, and manipulation activities.
Research-delivered sessions in both groups will last around 30-45 minutes. Caregivers will be encouraged to provide 2 more sessions every week lasting about 15-20 minutes/session. The research team will provide caregivers in both groups with the required materials for caregiver sessions. In the SPEED group, the ride-on toy will be left with the family for the duration of the intervention (i.e., 6 weeks). Both researchers and caregivers will be asked to keep track of training sessions (duration, frequency, etc.) using a training log. During the course of the study, children in both groups will continue to receive treatment-as-usual through school or private settings. Families will be asked to log the therapies their child is receiving every week over the course of the study using a training diary (# of times/week, duration of each session, type of therapy received) provided by the researchers. Researchers will video record all testing and researcher-delivered training sessions so that children's performance can be scored later.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- Boys and girls between the ages of 3 - 8 years
- Diagnosed with hemiplegia by a medical doctor with clear asymmetry in upper extremity strength and control (i.e., one upper limb is clearly weaker than the other)
- Can maintain a supported sitting position for at least 15 minutes
- Only lower limb involvement
- Recent history (within past 6 months) of trauma or surgery or Botox
- Uncorrected blindness/profound visual impairment
- Fixed deformities at wrist or hand
- No active control in affected UE
- Inability to follow 2-step directions
- Weight > 150 lbs.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SPEED (Strength and Power in upper Extremities through Exploratory Driving) SPEED Training Children will receive training focused on improving affected arm function using modified, joystick-operated ride-on toys. The commercial ride-on toys will be modified to allow operation in a single joystick control mode provided on the child's affected side. The manualized SPEED sessions will involve 2 components: (a) Multidirectional navigational games where children will use their affected UE to drive and maneuver the toy and (b) Object-based UE tasks completed at intermediate stops/stations during navigation. Navigational opportunities will encourage children to navigate through paths of different shapes, sizes, and complexity levels (e.g., straight, circle, diamond, slalom, obstacle courses etc.) Object-based tasks will encourage functional UE movement patterns during object interactions such as reaching, throwing, catching, pulling, pushing, lifting, knocking, holding, grasping, opening, closing, release, and manipulation. CRAFT (Creative Rehabilitation for Arm Functional Training) CRAFT Training Children will engage in seated creative motor games focused on promoting gross and fine motor UE function. Training sessions will encourage use of the affected UE during unimanual and bimanual activities. Each training session will involve the following components: (a) Stretching exercises and (b) Task-oriented strengthening activities. Stretching exercises will involve range of motion exercises to encourage active warmup of proximal (shoulder, elbow) and distal (wrist, hand) UE muscles and movement dissociation. Task-oriented strengthening will involve use of the affected UE as a mobilizer and a stabilizer during building (e.g., Play-Doh, blocks, puzzles) and art-craft activities (e.g., folding, cutting, pasting, coloring). Task-oriented practice will emphasize skills such as reaching, grasping, release, and manipulation of training supplies.
- Primary Outcome Measures
Name Time Method Treatment adherence From start to end of the 6-week intervention phase on a weekly basis Researchers and caregivers will maintain training logs to document the frequency (# of sessions/week) and duration (time per session) of training sessions. In the SPEED group, the ride-on toy will collect data on amount of device use during training sessions.
Treatment retention From date of randomization to date of the final data collection visit with the last participant, assessed over 24 months Researchers will report treatment retention (# of families who withdrew). The researchers will track the # of families who withdrew from the study, the timepoint within the study timeline of withdrawal, and the reasons for withdrawal.
Treatment satisfaction At 8 weeks (i.e., at the posttest visit conducted following completion of the 6-week intervention phase) The researchers will use the 16-item Physical Activity Enjoyment Scale (PAES) with children (delivered in an interview format) scored on a Likert scale of 1 (Disagree a lot) to 5 (Agree a lot) at posttest to assess perceived competence, pleasure/enjoyment, control, and sense of success. Caregivers will complete exit questionnaires/interviews to assess perceived program satisfaction, burden, willingness to continue training beyond the study, likelihood of recommending training to others, and child motivation/engagement during the training.
Changes in use of affected arm in functional activities Baseline (i.e., pretest conducted in week 1), at 8 weeks (i.e., at posttest after completion of the 6-week intervention), and at 12 weeks (i.e., at 1-month followup after the end of intervention phase) The Shriner's Hospital Upper Extremity Evaluation (SHUEE) is a video-based test that analyzes affected UE use spontaneously and on tester demand during 16 bimanual tasks in 3-18-year-olds. It has 3 components: spontaneous functional analysis (SFA), dynamic positional analysis (DPA), and grasp-release analysis (GRA), scored on a 2- to 6-point ordinal scale. The SHUEE assessment includes evaluation of spontaneous use of the involved UE and segmental alignment of the affected UE during performance of tasks on demand, for example, unscrewing a bottle cap, removing money from a wallet, putting socks on, etc. The SFA is scored on a scale from 0 to 5 where higher ratings indicate better performance. The DPA is scored on a scale from 0 to 3, where higher ratings indicate better performance. The GRA is scored on scale from 0 to 1, where higher ratings indicate better performance.
Changes in hand grip strength Baseline (i.e., pretest conducted in week 1), at 8 weeks (i.e., at posttest after completion of the 6-week intervention), and at 12 weeks (i.e., at 1-month followup after the end of the intervention phase) A calibrated digital Jamar dynamometer will be used to measure grip strength while seated with forearm supported. Following a single sub-maximal practice trial, a single maximal trial of 3-4 seconds will be collected from each hand.
- Secondary Outcome Measures
Name Time Method Changes in parent-rated scores on functional use of the affected arm Baseline (i.e., pretest conducted in week 1), at 8 weeks (i.e., at posttest after completion of the 6-week intervention), and at 12 weeks (i.e., at 1-month followup after 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 21 manual activities are rated by parents on a 3-point scale of "impossible", "difficult", or "easy". Items become increasingly difficult in terms of required bimanual function. Investigators will report changes in logit scores over the course of the training program.
Changes in child engagement during training sessions Early (week 1), Mid (week 3), and Late (week 6) training sessions within the 6-week intervention phase The researchers will code 1 early, 1 mid, and 1 late researcher-administered session during the intervention phase in both groups (using Datavyu video coding software) to assess the child's affect and attention to the task. Specifically, in terms of affect, for each training session (early, mid, and late), researchers will code the percent duration of session spent in positive and negative affective states. In addition, training sessions (early, mid, and late session) will be coded for the child's attention patterns. The research team will code the percent duration of the session that the child attended towards task-appropriate and task-inappropriate targets. Specifically, investigators will code for attention directed towards: (a) task, (b) social partners, and (d) elsewhere.
Changes in implementation fidelity during training sessions and factors impacting training delivery Early (week 1), Mid (week 3), and late (week 6) training sessions within the 6-week intervention phase and at week 8 (posttest following completion of the intervention phase) In both training groups, a coder naïve to study aims will randomly choose and code videos (one each of early, mid, and late researcher-delivered sessions) using custom-designed fidelity checklists to assess adherence to the manualized training protocols. Caregivers will fill exit questionnaires at posttest to report ease of implementation of the training programs, barriers and facilitators related to session delivery, and adequacy of researcher support to deliver caregiver sessions.
Changes in habitual arm activity and arm asymmetry Baseline (i.e., pretest conducted in week 1), at 8 weeks (i.e., at posttest after completion of the 6-week intervention), and at 12 weeks (i.e., at 1-month followup after the end of intervention phase) Children will be asked to wear 2 wrist activity monitors (ActiGraph devices), one each on both wrists, for the duration of 1 week, at 3 time points : (a) baseline/pretest, (b) posttest following completion of the 6-week intervention phase, and (c) followup (i.e., 1 month following intervention completion). Children will be asked to wear the monitors for a period of 1 week at all 3 time points. Children will be asked to wear the monitors continuously when awake and while sleeping (minimum of 4 days - 1 weekend day and 3 weekdays) over the course of the week. Investigators will report extent of asymmetry in affected versus unaffected arm use across the time points.
Change in affected arm movement control Baseline (i.e., pretest conducted in week 1), at 8 weeks (i.e., at posttest after completion of the 6-week intervention), and at 12 weeks (i.e., at 1-month followup after 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 movements, grasp, protective extension, and weight bearing. The tool includes 36 items that evaluate movement patterns and hand function in children with Cerebral Palsy and are scored on a dichotomous scale (minimum value = 1, maximum value = 2), with higher scores indicating better performance. The research team will report total scores and 4 sub-domain scores on the QUEST.
Changes in independent navigational control Early (week 1), Mid (week 3), and Late (week 6) training sessions within the 6-week intervention phase Early, mid, \& late training sessions (one session at each time point) of children in the SPEED group will be coded for percent duration of session engaged in assisted (child needs trainer-provided manual assistance) versus independent (child is able to drive the toy unassisted) navigation.
Changes in maximum UE joint angles and overall range of motion on the affected arm Baseline (i.e., pretest conducted in week 1), at 8 weeks (i.e., at posttest after completion of the 6-week intervention), and at 12 weeks (i.e., at 1-month followup after the end of intervention phase) Movement kinematics will be collected from both UEs during the following tasks: (a) range of motion tasks involving shoulder, elbow, forearm, and wrist movements (adapted from tasks from the QUEST and SHUEE tests) and (b) sequential bimanual tasks adapted from motor tests (i.e., clean-up task with 6 blocks requiring the child to grasp each block, transfer to the other hand, and release into a small cup). Sensors (Inertial Measurement Units (IMUs)) will be placed on both hands, both forearms, both arms, and the C7 spinous process. The research team will report maximum joint angles and overall joint range of motion.
Trial Locations
- Locations (1)
Physical Therapy Program, Department of Kinesiology, University of Connecticut
🇺🇸Storrs, Connecticut, United States