Ride-on Toys to Improve Arm Function in Children with Hemiplegia
This study is looking at two types of play-based training programs to help children aged 3 to 8 with hemiplegia (weakness on one side of the body) improve their arm function. One program, called SPEED Training, uses ride-on toys controlled with the child's affected arm to navigate and complete challenges. The other, CRAFT Training, involves seated activities like traditional occupational therapy, also with playful themes. Researchers want to see how well these programs can be put into practice and if families are happy with them. They will also compare how each program affects the child's arm movement and how much they use their affected arm in daily life. The study aims to enroll 30 children.
- Study design
- This is an interventional study that will enroll 30 participants. Children will be randomly assigned to either the SPEED Training or CRAFT Training group.
- What's involved
- You would have a phone screening, a pretest session with assessments and activity monitors for one week, a 6-week intervention phase, and then posttest and 1-month follow-up assessments.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 1 month after the 6-week intervention phase, with assessments at week 8 and week 12.
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A Novel Program Using Ride-on Toys to Improve Upper Extremity Function in Children With Hemiplegia
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
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What this trial measures
- Treatment adherenceFrom 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 retentionFrom 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 satisfactionAt 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 activitiesBaseline (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 strengthBaseline (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.