Speech and Arm Combined Exergame

NCT06817941 | Recruiting

• 1 other identifier: Pro2024001772
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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).

  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

  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

  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

  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

  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

  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)

  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)

Study Arms (3)

Speech only (Group 1)

EXPERIMENTAL

Participants in Group 1 will play three video games using their voice only.

Behavioral: Speech only

Arm only (Group 2)

EXPERIMENTAL

Participants in Group 2 will play three video games using their impaired hand and arm only.

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.

Behavioral: Speech and arm combined

Interventions

Speech only BEHAVIORAL

Participants will be using a computer-based speech therapy games at home to train their speech clarity for 8 weeks. While playing these games, a webcam will be recording the participant's speech loudness and mouth opening.

Speech only (Group 1)

Hand/Arm only BEHAVIORAL

Participants will be using a computer-based therapy games at home to train their hand and arm movement for 8 weeks. While playing these games, a motion detector will be used to measure how quickly and accurately the participants can move their fingers, wrist, and arm.

Arm only (Group 2)

Speech and arm combined BEHAVIORAL

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

Speech/Arm combined (Group 3)

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

Rutgers School of Health Professions

Newark, New Jersey, 07101, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 33656916 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy; Dysarthria; Paresis

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Articulation Disorders; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Young Hwa M Chang, PhD, CCC-SLP

  Rutgers University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: January 24, 2025
• First Posted: February 10, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: February 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)