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Cerebral Palsy (CP)SPACENCT06817941

Speech and Arm Combined Exergame

A study testing Speech only, Hand/Arm only and Speech and arm combined in people with Cerebral Palsy (CP) and Dysarthria, run by Rutgers, The State University of New Jersey at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 8 to 17 years
Conditions the study is for
Cerebral Palsy (CP), Dysarthria
What is being tested?
Speech only, Hand/Arm only and Speech and arm combined
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteUnited States
Study dates
1 Jun 2025to Aug 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • (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
Show all 9Show fewer
  • (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.

Who cannot join

  • (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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Young Hwa M Chang, PhD, CCC-SLP contact

617-959-4597

ym.chang@rutgers.edu

Qinyin Qiu, PhD contact

908-217-6290

qiuqi@shp.rutgers.edu

United States1 site, 1 recruiting
  • Rutgers School of Health Professions

    Newark, New Jersey, 07101

    Young Hwa M Chang, PhD, CCC-SLP, 617-959-4597, ym.chang@rutgers.edu

    Young Hwa M Chang, PhD, CCC-SLP

    Recruiting

Other trials in United States

About this study

Official title: Enhancing Rehabilitation Outcomes in Cerebral Palsy Through Gamified Multidisciplinary Interventions: Integrating Speech and Upper Extremity Motor Therapy

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.

Read more

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.

Read the detailed description

In recent decades, rigorous treatment utilizing the principles of motor learning and activity-dependent neuroplasticity have shown significant improvement in speech and upper extremity (UE) function in children with cerebral palsy (CP). While intensive motor treatment can provide significant therapeutic benefits, it is often difficult for children to participate and complete such therapy, especially when they find the process to be tedious or lack immediate feedback and tracking of improvement over time. The need to maximize engagement during therapy is thus pivotal to ensure that treatment is both effective and sustainable. To this end, gamified therapy may be ideal, as it has been well-documented in literature to enhance not only targeted motor functions during UE therapy but also participation and motivation in children. Furthermore, combining speech and UE in a multidisciplinary gamified therapy may provide benefits to many children with CP who have concomitant impairment of speech and UE. Due to the neurological similarities underlying speech production and hand/arm movement execution, synergistic effects may be expected when treating both domains simultaneously. Research on this clinically significant topic deserves attention and further examination.

Specifically, in this proposed study, the following aims will be targeted:

Aim 1: Develop computer-based therapy games designed to improve speech intelligibility and UE function.

Aim 2: Evaluate the feasibility and effectiveness of a gamified multidisciplinary treatment method (i.e., combined speech and UE) and compare it to the independent effects of gamified speech and UE therapy.

Aim 3: Examine the potential overlap in the neural correlates of speech and UE movement as well as the post-treatment changes in these correlates under the combined versus independent conditions.

The goal of this project is to develop and evaluate the feasibility and effectiveness of a gamified multidisciplinary treatment for speech and UE, and to examine the underlying neural correlates of the two domains in response to treatment. This approach will enhance participation of children with CP and, consequently, the effectiveness of therapy aimed at improving speech intelligibility and UE function. Furthermore, the games that will be developed can be part of a home-based therapy system and thus used in telerehabilitation to provide treatment to a much greater number of children. The impact of these research goals is crucial to refine therapeutic approaches and tailor them to meet the specific needs of children with CP, ultimately aiming to increase the children's independence and improve their quality of life.

Cerebral Palsy (CP) is the leading cause of motor impairment in children. Approximately 1 in 345 children in the United States have CP. It is a heterogeneous, nonprogressive, and lifelong disorder, with many children presenting with the motor speech disorder of dysarthria as well as sensorimotor issues of the upper limb. The intelligibility reductions in dysarthria, along with the sensorimotor issues affecting the upper extremities, often limit these children's ability to communicate and perform activities of daily living (ADLs). This may negatively impact social development, reduce their quality of life, and result in social isolation or depression. Therefore, therapeutic exercises targeting improvement in speech and UE are essential for children with CP throughout life as they reach new developmental milestones and functional demands.

Gamified upper extremity (UE) and speech treatment for children with CP:

Positive effects of gamified therapy have been documented in children with CP for UE training. Training using computer-based games showed greater recovery of upper extremity function compared to traditional therapies in young people with CP in multiple studies, but that most studies were of lower quality and design. In addition to UE limitations, more than 50% of children with CP present with a motor speech disorder of dysarthria, which can negatively impact speech intelligibility and create a barrier to communication. Therefore, improving intelligibility is also a fundamental goal of speech intervention for this population.

This research seeks to develop computer-based therapy games to train the UE and speech in children with CP. The UE training component will focus on fine motor activities needed to perform activities of daily living. The speech training component leverages the intelligibility benefits of an intensive speech treatment method for children with CP (i.e., Speech Intelligibility Treatment; SIT).

Multidisciplinary treatment:

Speech and UE therapy will be integrated into a multidisciplinary gamified treatment to investigate the benefits of combined speech and UE training. Such combined treatment may be effective because speech and arm motions are linked together behaviorally, neurologically, and developmentally. Furthermore, since children with CP often receive multiple types of therapies together, a multidisciplinary goal-directed treatment that targets specific movement skills in speech and UE will be clinically and practically applicable. Such co-treatment will facilitate more seamless care, rather than speech-language and mobility gains being made in a fragmented manner. Finally, both speech and arm motor training follow similar motor learning principles, which state that incorporating contextual interference during skilled motor training may lead to greater retention of learned skills. For example, improvement in fine motor skills may transfer to enhancements in motor control elsewhere, including the orolingual muscles of articulation. Combining speech and UE motor training may, therefore, allow for interdisciplinary skill transfer, which will result in more enduring benefits and the retention of acquired abilities.

Neural correlates of speech and UE movement changes:

Execution of UE movement recruits activation of cortical areas in the primary sensorimotor system, premotor areas, and executive networks such as the parietal cortex and prefrontal cortex. Similarly, speech execution recruits areas in the sensorimotor and frontoparietal cortices. This overlap in cortical resources raises important questions about whether training UE movement and speech simultaneously would increase activations of these overlapping cortical areas or decrease them due to competition. Furthermore, questions of whether simultaneous training leads to a change in the activation pattern of all the cortical resources remain unanswered. We aim to answer these questions by utilizing the fNIRS technology to compare the neural changes as a function of treatment.

This study will advance the field's knowledge of combined speech and UE therapy, and how such multidisciplinary treatment can be beneficial to children with CP. Successful completion of this research may ultimately increase the children's independence and improve their quality of life.

Being tested
Speech only, Hand/Arm only, Speech and arm combined
Keywords
cerebral palsy, children, dysarthria, motor speech disorder, upper extremity, arm weakness, intervention, video games, fNIRS, neuroimaging, therapy, rehabilitation
Medical subject headings
Cerebral Palsy, Dysarthria, Paresis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Speech onlyBehavioural

    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 onlyBehavioural

    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 combinedBehavioural

    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 groups in NCT06817941
Study groupRoleWhat they receive
Speech only (Group 1)ExperimentalParticipants in Group 1 will play three video games using their voice only.
Receives: Behavioral: Speech only
Arm only (Group 2)ExperimentalParticipants in Group 2 will play three video games using their impaired hand and arm only.
Receives: Behavioral: Hand/Arm only
Speech/Arm combined (Group 3)ExperimentalParticipants in Group 3 will play three video games using both voice and hand/arm.
Receives: Behavioral: Speech and arm combined

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Intelligibility measures

    To assess the word and sentence intelligibility changes in the participating children with CP. Once the child participants' data are collected, adult listeners will come to the Rutgers SLP Clinic to assess speech changes in these children. Each listener will spend approximately 30 minutes to one hour listening to the children's speech (words and sentences) and type on a laptop what they heard. They will also indicate how easy or difficult the utterance was to understand using a visual analog scale on the laptop. The anchor points provided on the scale will be: difficult to understand (score = 0) to easy to understand (score = 100). Each listener will provide their rating by sliding a pointer on this scale between the two anchor points. The words and sentences that the listeners listen to are audio recordings collected during the child participants' four assessment sessions (pre-treatment, mid-treatment, post-treatment, and retention).

    Measured: 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)

  2. Melbourne Assessment 2

    MA2 is a 14 item criterion-referenced test for evaluating four elements of upper limb movement quality in children with a neurological impairment

    Measured: 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)

Secondary outcomes (17)
  1. Speech rate

    The speed at which the participant can articulate a word (syllables per second) or a sentence (words per second)

    Measured: 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)

  2. Vowel space area

    Area of oral aperture during speech, measured with four American English corner vowels

    Measured: 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)

  3. Sound pressure level

    Loudness of speech, measured in dB

    Measured: 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)

  4. FOCUS questionnaire

    Social communication questionnaire that examines how the participants' use of speech changed after treatment

    Measured: 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)

  5. Box and Block test (BBT)

    BBT is a standardized activity level test used to measure the gross manual dexterity. The subject is given 60 seconds to move as many blocks as possible over a partition to the other, using one hand.

    Measured: 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)

  6. Fingers range of motion

    The Hand Open Range value is calculated by measuring the difference in the average distance between the fingertips and the center of the palm across all four fingers in these two positions.

    Measured: 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)

  7. Wrist range of motion

    The participant extends and flexes their wrist against gravity with their forearm in a fixed position. Angular difference between these two positions is reported as the wrist pitch range.

    Measured: 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)

  8. Forearm range of motion

    The participant moves and holds their hand in pronation and supination with their elbow fixed.

    Measured: 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)

  9. Speed of fingers open/close

    Measure how many times the participants can open and close fingers in 5 seconds.

    Measured: 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)

  10. Speed of wrist flexion/extension

    Measure how many times the participants can move the wrist up and down (flex, extend) in 5 seconds

    Measured: 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)

  11. Speed of forearm pronation/supination

    Measure how many times the participants can rotate their forearm in 5 seconds

    Measured: 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)

  12. Accuracy of finger open/close

    The participant attempts to trace an irregular wave which moves on the screen from left to right at a constant speed. Accuracy is calculated as the root mean square error between the cursor position and the corresponding target point on the wave.

    Measured: 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)

  13. Accuracy of wrist flexion/extension

    The participant controls a cursor that moves up and down by flexing and extending their wrist. Task and accuracy values are calculated.

    Measured: 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)

  14. Accuracy of forearm pronation/supination

    The participant controls a cursor that moves up and down by pronating and supinating their hand. Task and accuracy calculations were performed.

    Measured: 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)

  15. Handheld Dynamometry

    Grip strength measured with hand dynamometry

    Measured: 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)

  16. CP-QOL

    Quality of life measure for person with CP

    Measured: 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)

  17. fNIRS

    fNIRS will be used as a measure of hemodynamic activation during speech and hand/arm movement tasks.

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2025
  2. Study start1 Jun 2025
  3. Primary completionApr 2027 (estimated)
  4. Study completionAug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06817941
Sponsor's protocol ID
Pro2024001772
Acronym
SPACE
Status last verified
Jun 2026
First submitted
24 Jan 2025
Last updated
12 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: This is a small pilot study, and therefore, we do not plan to share IPD.

Publications

  • Levy ES, Chang YM, Hwang K, McAuliffe MJ. Perceptual and Acoustic Effects of Dual-Focus Speech Treatment in Children With Dysarthria. J Speech Lang Hear Res. 2021 Jun 18;64(6S):2301-2316. doi: 10.1044/2020_JSLHR-20-00301. Epub 2021 Mar 3.

    PubMed 33656916

Questions about this trial

What is this clinical trial studying?

A study testing Speech only, Hand/Arm only and Speech and arm combined in people with Cerebral Palsy (CP) and Dysarthria, run by Rutgers, The State University of New Jersey at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Young Hwa M Chang, PhD, CCC-SLP (617-959-4597, ym.chang@rutgers.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06817941, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.

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