| NCT ID | NCT06817941 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rutgers, The State University of New Jersey |
| Condition | Cerebral Palsy (CP) |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2025-02 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 15 participants in total. It began in 2025-02 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to develop innovative home therapy games to train the weak arm and improve speech intelligibility (clarity) of children with hemiplegia from cerebral palsy. The investigators are exploring the effects of these therapy games and how they change the children's speech, hand movement, and brain activation. 15 children who are 8-17 years old will be recruited for this study. These children should have a diagnosis of cerebral palsy, mild to moderate speech issues but use speech as the primary mode of communication, mild to moderate movement difficulty and muscle spasticity, adequate hearing (pass a hearing screening), and be able to follow simple task-related directions. Children who have severe vision impairment that limits the child's ability to interact with the entire computer screen, have severe arm weakness so they cannot move their arm enough to interact with the computer games, have severe increase in tone in their weak arm, or have difficulty following instructions or paying attention to computer video games for at least 10 minutes cannot participate in this study. The therapy games will take 8 weeks to finish at home. Each child will play these games for 30 minutes each day, 5 days per week. In addition, children will come to the lab 4 times for speech and hand movement assessment: (1) 1st assessment takes place immediately before the child start to play the video games. (2) 2nd assessment takes place 4 weeks (midpoint) after the child starts to play the games. (3) 3rd assessment takes place immediately after the video games are finished. (4) 4th assessment takes place 6 weeks after the video games are finished. Each assessment should take about 2 hours to complete in the Rutgers movement lab or at Rutgers SLP Clinic. A total of 15 children will take part in this research study. The research will last for 2 years overall.
Eligibility Criteria
Inclusion Criteria: * (1) diagnosis of CP * (2) age between 8-17 years (i.e., pediatric age) * (3) use speech as the primary mode of communication * (4) mild to moderate dysarthria * (5) Manual Ability Classification System (MACS) level I to III * (6) Gross Motor Function Classification System (GMFCS) level I to IV * (7) mild to moderate muscle spasticity of the arm with a Modified Tardieu Scale of 0-3 * (8) pass bilateral pure-tone hearing screening at 25 dB HL (at 500, 1000, 2000, and 4000 Hz) * (9) able to follow simple task-related directions, including repeating short phrases. Exclusion Criteria: * (1) severe vision impairment that limits the child's ability to interact with the entire computer screen * (2) dyskinetic CP or spastic diplegia * (3) English is not their first or primary language.
Contact & Investigator
Young Hwa M Chang, PhD, CCC-SLP
PRINCIPAL INVESTIGATOR
Rutgers University
Frequently Asked Questions
Who can join the NCT06817941 clinical trial?
This trial is open to participants of all sexes, aged 8 Years or older, up to 17 Years, studying Cerebral Palsy (CP). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06817941 currently recruiting?
Yes, NCT06817941 is actively recruiting participants. Contact the research team at ym.chang@rutgers.edu for enrollment information.
Where is the NCT06817941 trial being conducted?
This trial is being conducted at Newark, United States.
Who is sponsoring the NCT06817941 clinical trial?
NCT06817941 is sponsored by Rutgers, The State University of New Jersey. The principal investigator is Young Hwa M Chang, PhD, CCC-SLP at Rutgers University. The trial plans to enroll 15 participants.
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