Speech and Arm Combined Exergame

Part of paid clinical trials in Newark, New Jersey.

Sponsor
Rutgers, The State University of New Jersey
Study ID
NCT06817941
Status
Recruiting
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Conditions

  • Cerebral Palsy (CP)
  • Dysarthria

Eligibility Criteria

Sex
ALL
Age
8 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Speech only — BEHAVIORAL
    Participants will be using a computer-based speech therapy games at home to train their speech clarity for 8 weeks. While playing these games, a webcam will be recording the participant's speech loudness and mouth opening.
  • Hand/Arm only — BEHAVIORAL
    Participants will be using a computer-based therapy games at home to train their hand and arm movement for 8 weeks. While playing these games, a motion detector will be used to measure how quickly and accurately the participants can move their fingers, wrist, and arm.
  • Speech and arm combined — BEHAVIORAL
    Participants will be using a computer-based therapy games at home to train their speech clarity and hand/arm movement together for 8 weeks. While playing these games, a webcam will be recording the participant's speech loudness and mouth opening. A motion detector will also be used to measure how quickly and accurately the participants can move their fingers, wrist, and arm.

Study Details

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.

Key Dates

Start date
Feb 28, 2025
Status verified
Feb 2025
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
15 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Speech only (Group 1)
    Participants in Group 1 will play three video games using their voice only.
  • Experimental: Arm only (Group 2)
    Participants in Group 2 will play three video games using their impaired hand and arm only.
  • Experimental: Speech/Arm combined (Group 3)
    Participants in Group 3 will play three video games using both voice and hand/arm.

Primary Outcome Measure

Intelligibility measures [ Time Frame: Pre-treatment (1-2 weeks before treatment), mid-treatment (4 weeks after treatment begins), post-treatment (immediately after treatment ends at 8 weeks), 6-week retention (6 weeks after treatment ends) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Rutgers School of Health ProfessionsNewarkNew Jersey07101
Young Hwa M Chang, PhD, CCC-SLP
[email protected]
617-959-4597
Young Hwa M Chang, PhD, CCC-SLP (PRINCIPAL_INVESTIGATOR)
Qinyin Qiu, PhD (PRINCIPAL_INVESTIGATOR)
Jigna Patel, PT, PhD (SUB_INVESTIGATOR)
Soha Saleh, PhD (SUB_INVESTIGATOR)
Hannah Shoval, MD (SUB_INVESTIGATOR)

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