Enhancing Rehabilitation Outcomes in Cerebral Palsy Through Gamified Multidisciplinary Interventions: Integrating Speech and Upper Extremity Motor Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Intelligibility measures
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(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.
排除标准
- •(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.
研究组 & 干预措施
Speech only (Group 1)
Participants in Group 1 will play three video games using their voice only.
干预措施: Speech only (Behavioral)
Arm only (Group 2)
Participants in Group 2 will play three video games using their impaired hand and arm only.
干预措施: Hand/Arm only (Behavioral)
Speech/Arm combined (Group 3)
Participants in Group 3 will play three video games using both voice and hand/arm.
干预措施: Speech and arm combined (Behavioral)
结局指标
主要结局
Intelligibility measures
时间窗: 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
时间窗: 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
次要结局
- 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))
- 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))
- 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))
- 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))
- Speed of fingers open/close(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(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(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(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(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(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(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(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(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(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(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(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))
研究者
Young Hwa Michelle Chang, Ph.D., CCC-SLP
Assistant professor
Rutgers, The State University of New Jersey