A Novel Program Using Ride-on Toys to Improve Upper Extremity Function in Children With Hemiplegia

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-8
SponsorUniversity of Connecticut

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • SPEED Training

    Device

    Children will use ride-on toys controlled using their affected arm to navigate through their environment and complete playful theme-based challenges. Children will use their affected UE during navigation to start and stop the toy, move steadily forward and backward, turn to the right and left, perform 180° and 360° turns to either side, and avoid obstacles. Children will complete object-based UE tasks requiring gross and fine motor control at intermediate stops during navigation. Navigational tasks will be progressed by increasing complexity of paths (straight to slalom paths needing more directional changes), spaces (wide to narrow spaces), and precision (obstacle courses and mazes requiring skillful navigation, motor planning, and route finding). Object-based tasks will be progressed in terms of force requirements (small to large forces), range of motion (near to far reaches), precision (manipulation of large to small objects), and speed of movements (slow to fast).

  • CRAFT Training

    Behavioral

    Children will engage in predominantly seated activities based on conventional occupational therapy to promote unimanual and bimanual UE function. Training sessions will be based on playful child-friendly themes (e.g., dinosaurs, space exploration, aquatic theme, etc.) and all training activities will incorporate the session theme. Activities will involve practice of functional gross and fine motor UE movement patterns that children typically use during daily life. Training will emphasize the use of the affected UE in different roles (i.e., stabilizer, mobilizer, and active and passive assist) during warm-up, building, and art-craft activities. The training will be progressed in terms of forces needed, range of motion, precision, and movement speed.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: SPEED (Strength and Power in upper Extremities through Exploratory Driving)Experimental treatment 1 intervention
Group B: CRAFT (Creative Rehabilitation for Arm Functional Training)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Treatment adherence

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.

Time frame
From start to end of the 6-week intervention phase on a weekly basis
2

Treatment retention

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.

Time frame
From date of randomization to date of the final data collection visit with the last participant, assessed over 24 months
3

Treatment satisfaction

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.

Time frame
At 8 weeks (i.e., at the posttest visit conducted following completion of the 6-week intervention phase)
4

Changes in use of affected arm in functional activities

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.

Time frame
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)

Secondary outcomes

1

Changes in implementation fidelity during training sessions and factors impacting training delivery

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.

Time frame
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)
2

Changes in child engagement during training sessions

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.

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

Changes in parent-rated scores on functional use of the affected arm

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.

Time frame
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)
4

Change in affected arm movement control

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.

Time frame
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)

Other outcomes

Sponsors and contacts

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University of Connecticut

Lead sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator