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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
United States1 site, 1 recruiting
- 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
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.
- Conditions
- Cerebral Palsy (CP), Dysarthria
- 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 group | Role | What they receive |
|---|---|---|
| Speech only (Group 1) | Experimental | Participants in Group 1 will play three video games using their voice only. Receives: Behavioral: Speech only |
| Arm only (Group 2) | Experimental | Participants 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) | Experimental | Participants 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.
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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.
- First posted10 Feb 2025
- Study start1 Jun 2025
- Primary completionApr 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral Palsy (CP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young Hwa Michelle Chang, Ph.D., CCC-SLP, Rutgers, The State University of New Jersey
- Investigators
- Young Hwa M Chang, PhD, CCC-SLP, Principal investigator, Rutgers University
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Rehabilitation Outcomes in Cerebral Palsy Through Gamified Multidisciplinary Interventions: Integrating Speech and Upper Extremity Motor Therapy
- ClinicalTrials.gov ID
- NCT06817941
- Acronym / sponsor ID
- SPACE / Pro2024001772
- Conditions
- Cerebral Palsy (CP), Dysarthria
- Keywords
- cerebral palsy, children, dysarthria, motor speech disorder, upper extremity, arm weakness, intervention, video games
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 10 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Speech only (Group 1) | Experimental | Behavioral: Speech onlyParticipants in Group 1 will play three video games using their voice only. |
| Arm only (Group 2) | Experimental | Behavioral: Hand/Arm onlyParticipants in Group 2 will play three video games using their impaired hand and arm only. |
| Speech/Arm combined (Group 3) | Experimental | Behavioral: Speech and arm combinedParticipants in Group 3 will play three video games using both voice and hand/arm. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- (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
Key exclusion criteria (3 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Speech onlyParticipants 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. | Behavioural | Speech only (Group 1) |
| Hand/Arm onlyParticipants 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. | Behavioural | Arm only (Group 2) |
| Speech and arm combinedParticipants 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. | Behavioural | Speech/Arm combined (Group 3) |
Primary outcome
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)
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).
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)
MA2 is a 14 item criterion-referenced test for evaluating four elements of upper limb movement quality in children with a neurological impairment
17 secondary outcomes
Speech rate
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)
Vowel space area
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)
Sound pressure level
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)
FOCUS questionnaire
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)
Box and Block test (BBT)
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)
Fingers range of motion
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)
Wrist range of motion
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)
Forearm range of motion
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)
Speed of fingers open/close
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)
Speed of wrist flexion/extension
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)
Speed of forearm pronation/supination
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)
Accuracy of finger open/close
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)
Accuracy of wrist flexion/extension
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)
Accuracy of forearm pronation/supination
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)
Handheld Dynamometry
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)
CP-QOL
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)
fNIRS
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Background: PubMed 33656916Levy 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.
- Individual participant dataSharing planned: No. This is a small pilot study, and therefore, we do not plan to share IPD.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Young Hwa M Chang, PhD, CCC-SLP principal investigator
Rutgers University
1 site in 1 country: see every site and its status.
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.