Recruiting

Speech & Arm

Sponsor:

Rutgers, The State University of New Jersey

Code:

NCT06817941

Conditions

Cerebral Palsy (CP)

Dysarthria

Eligibility Criteria

Sex: All

Age: 8 - 17

Healthy Volunteers: Not accepted

Interventions

Speech only

Hand/Arm only

Speech and arm combined

Study Details

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.

Conditions

Cerebral Palsy (CP)

Dysarthria

Study ID

NCT06817941

Start date

Jun 1, 2025

Status verified date

Jun, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 17

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

15 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Speech only

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

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

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.

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) ]
  • Melbourne Assessment 2 [ 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 and Locations

Central contacts

Young Hwa M Chang, PhD, CCC-SLP

617-959-4597ym.chang@rutgers.edu

Qinyin Qiu, PhD

908-217-6290qiuqi@shp.rutgers.edu

Locations

Rutgers School of Health Professions

Recruiting

Newark, New Jersey, United States, 07101

Contacts

Young Hwa M Chang, PhD, CCC-SLP

617-959-4597ym.chang@rutgers.edu

Principal Investigator:

Young Hwa M Chang, PhD, CCC-SLP

More Information

Sponsor

Rutgers, The State University of New Jersey

Last update posted

Jun 12, 2026

Last verified

Jun, 2026

Keywords

  • cerebral palsy
  • children
  • dysarthria
  • motor speech disorder
  • upper extremity
  • arm weakness
  • intervention
  • video games
  • fNIRS
  • neuroimaging
  • therapy
  • rehabilitation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rutgers, The State University of New Jersey on 2026-06-12.