Hemiplegic Cerebral Palsy Clinical Trial
Official title:
Effects of a Novel, Home-based Training Program Using a Joystick-operated, Modified, Powered Ride-on-car on Bilateral Upper Extremity Function in Children With Hemiplegic Cerebral Palsy
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.
Status | Recruiting |
Enrollment | 15 |
Est. completion date | April 30, 2025 |
Est. primary completion date | April 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Years to 8 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Physical Therapy Program, Department of Kinesiology, University of Connecticut | Storrs | Connecticut |
Lead Sponsor | Collaborator |
---|---|
University of Connecticut | American Academy for Cerebral Palsy & Developmental Medicine, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute for Biomedical Imaging and Bioengineering (NIBIB), National Institute of Neurological Disorders and Stroke (NINDS), Virginia Tech (National Pediatric Rehabilitation Resource Center i.e. C-PROGRESS) |
United States,
Amonkar N, Kumavor P, Morgan K, Bubela D, Srinivasan S. Feasibility of Using Joystick-Operated Ride-on-Toys to Promote Upper Extremity Function in Children With Cerebral Palsy: A Pilot Study. Pediatr Phys Ther. 2022 Oct 1;34(4):508-517. doi: 10.1097/PEP.0000000000000944. Epub 2022 Aug 30. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 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. | Baseline, at 6-weeks (i.e., at the end of the control phase), at 12-weeks (i.e., at the end of intervention phase) | |
Primary | Changes in use of affected arm in functional activities | 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. It provides a descriptive profile for comparing UE dynamic segmental alignment from pretest to posttest. The SHUEE assessment includes evaluation of active and passive range of motion (ROM), tone, a history-based assessment of the performance of activities of daily living, 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. | Baseline, at 6-weeks (i.e., at the end of the control phase), at 12-weeks (i.e., at the end of intervention phase) | |
Primary | Changes in habitual arm activity on the affected side | 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. | Baseline, at 6-weeks (i.e., at the end of the control phase), at 12-weeks (i.e., at the end of intervention phase); during the 6-week intervention phase: early (week 1) and late (week 6) training weeks | |
Primary | Changes in kinematic measures of movement control on the affected arm | 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 the speed, smoothness, variability, and symmetry of reaching trajectories. | Baseline, at 6-weeks (i.e., at the end of the control phase), at 12-weeks (i.e., at the end of intervention phase) | |
Primary | Changes in kinematic measures of movement control on the affected arm during ride-on-car navigation sessions | Kinematic data will be obtained during weekly researcher-delivered ride-on-car training sessions. | Early (week 1) and late (week 6) training weeks within the 6-week intervention phase | |
Primary | Treatment satisfaction | Children will complete the valid and reliable 16-item Physical Activity Enjoyment Scale (PAES) to rate their experience with the intervention. | At 12 weeks (i.e. following completion of the intervention and control phases each lasting for 6 weeks) | |
Primary | Perceived satisfaction with intervention | Children and caregivers will fill out exit questionnaires to assess training satisfaction, enjoyment, repeatability, and caregiver burden. | At 12 weeks (i.e. following completion of the intervention and control phases each lasting for 6 weeks) | |
Primary | Ease of implementation of training | Trainers will fill out posttest exit questionnaires to assess ease of implementation of the training program. | At 12 weeks (i.e. following completion of the intervention and control phases each lasting for 6 weeks) | |
Primary | Changes in treatment fidelity across training weeks | An unbiased coder will randomly code video data (one each of early, mid, and late sessions) from researcher-delivered sessions within the intervention phase using fidelity checklists to assess adherence to the training protocol. | Early (week 1), Mid (week 3), and late (week 6) training sessions within the 6-week intervention phase | |
Primary | Changes in toy use (in minutes/week) across training weeks | 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. | From start to end of 6-week intervention phase on a weekly basis | |
Primary | # of training sessions completed assessed using training logs | Researchers and caregivers will also maintain training logs during the intervention phase to document training # of sessions completed with information on session duration and child engagement | From start to end of 6-week intervention phase on a weekly basis | |
Secondary | 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 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", "difficult", or "easy". Items become increasingly difficulty in terms of required bimanual function. | Baseline, at 6-weeks (i.e., at the end of the control phase), at 12-weeks (i.e., at the end of intervention phase) | |
Secondary | Changes in amount of trainer assistance needed during navigation | Early, mid, & late training sessions will be coded for % duration of assisted (child needs trainer-provided manual assistance) versus independent navigation. | Early (week 1), mid (week 3), and late (week 6) training sessions within the 6-week intervention phase | |
Secondary | Changes in child attention during training sessions | Training sessions (one early, mid, and late session each) will be video-coded for attention (i.e., % duration of attention to task-relevant targets). | Early (week 1), mid (week 3), and late (week 6) sessions during the 6-week intervention phase | |
Secondary | Changes in child affect across training sessions | 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) | Early (week 1), mid (week 3), and late (week 6) sessions during the 6-week intervention phase | |
Secondary | Changes in duration of movement bouts during navigation across training sessions | Early, mid, & late training sessions will be coded for average duration of child-initiated, movement bouts normalized by driving time (a bout comprises 1 acceleration and 1 deceleration phase). | Early (week 1), mid (week 3), and late (week 6) sessions during the 6-week intervention phase | |
Secondary | Changes in rates of obstacle contacts across training sessions | Early, mid, & late training sessions will be coded for rates/session of path deviations and obstacle bumps. | Early (week 1), mid (week 3), and late (week 6) sessions during the 6-week intervention phase | |
Secondary | Changes in rates of path deviations across training sessions | Early, mid, & late training sessions will be coded for rates/session of path deviations. | Early (week 1), mid (week 3), and late (week 6) sessions during the 6-week intervention phase |
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