Speech and Arm Combined Exergame

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-17
SponsorRutgers, The State University of New Jersey

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

(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

Disqualifiers

(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 design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

  • 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.

Treatment groups

15 Participants
are divided into 3 treatment groups
Group A: Speech only (Group 1)Experimental treatment 1 intervention
Group B: Arm only (Group 2)Experimental treatment 1 intervention
Group C: Speech/Arm combined (Group 3)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

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).

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)
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

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)

Secondary outcomes

1

Speech rate

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

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)
2

Vowel space area

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

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)
3

Sound pressure level

Loudness of speech, measured in dB

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)
4

FOCUS questionnaire

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

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)

Other outcomes

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