Clinical trial NCT06817941: Speech and Arm Combined Exergame
Official title: Enhancing Rehabilitation Outcomes in Cerebral Palsy Through Gamified Multidisciplinary Interventions: Integrating Speech and Upper Extremity Motor Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cerebral Palsy (CP)
Dysarthria
Keywords: cerebral palsy
children
dysarthria
motor speech disorder
upper extremity
arm weakness
intervention
video games
fNIRS
neuroimaging
therapy
rehabilitation
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2025-02-10
Enrollment: 15
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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.

Primary outcomes:
measure: Intelligibility measures
timeFrame: 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)
measure: Melbourne Assessment 2
timeFrame: 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:
measure: Speech rate
timeFrame: 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)
measure: Vowel space area
timeFrame: 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)
measure: Sound pressure level
timeFrame: 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)
measure: FOCUS questionnaire
timeFrame: 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)
measure: Box and Block test (BBT)
timeFrame: 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)
measure: Fingers range of motion
timeFrame: 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)
measure: Wrist range of motion
timeFrame: 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)
measure: Forearm range of motion
timeFrame: 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)
measure: Speed of fingers open/close
timeFrame: 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)
measure: Speed of wrist flexion/extension
timeFrame: 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)
measure: Speed of forearm pronation/supination
timeFrame: 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)
measure: Accuracy of finger open/close
timeFrame: 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)
measure: Accuracy of wrist flexion/extension
timeFrame: 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)
measure: Accuracy of forearm pronation/supination
timeFrame: 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)
measure: Handheld Dynamometry
timeFrame: 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)
measure: CP-QOL
timeFrame: 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)
measure: fNIRS
timeFrame: 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)
Other outcomes:
Locations:
city: Newark
country: United States
facility: Rutgers School of Health Professions
state: New Jersey
Study officials:
affiliation: Rutgers University
name: Young Hwa M Chang, PhD, CCC-SLP
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.