Exergame for Cerebral Palsy

(SPACE Trial)

Overseen by Young Hwa M Chang, PhD, CCC-SLP

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Rutgers, The State University of New Jersey

Disqualifiers: Severe vision impairment, Dyskinetic CP, others

No Placebo Group

Trial Summary

What is the purpose of 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.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment Speech and Arm Combined Exergame for cerebral palsy?

Research shows that exergames can improve muscle strength in children with cerebral palsy when added to usual care, suggesting potential benefits for treatments like the Speech and Arm Combined Exergame. ^{1 2 3 4 5}

Is the exergame treatment safe for humans?

The research suggests that exergames, including those for cerebral palsy, are generally safe and can improve muscle strength in various populations, including children with cerebral palsy, when added to usual care. ^{1 2 4 5 6}

How is the Speech and Arm Combined Exergame treatment different from other treatments for cerebral palsy?

The Speech and Arm Combined Exergame treatment is unique because it combines exercise video games with speech and arm movements, potentially making rehabilitation more engaging and enjoyable for children with cerebral palsy. This approach may help improve muscle strength and motor function by integrating fun, interactive elements into therapy, which is different from traditional rehabilitation methods. ^{1 2 3 7 8}

Research Team

Young Hwa M Chang, PhD, CCC-SLP

Principal Investigator

Rutgers University

Eligibility Criteria

This trial is for children aged 8-17 with cerebral palsy and mild to moderate speech and arm movement difficulties. Participants must primarily communicate through speech, pass a hearing screening, and be able to engage with computer games for at least 10 minutes.

Inclusion Criteria

I mainly communicate by talking.

I am between 8 and 17 years old.

MACS level I to III

Exclusion Criteria

I have dyskinetic cerebral palsy or spastic diplegia.

My child has severe vision problems affecting their ability to see the whole computer screen.

English is not their first or primary language.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants engage in home-based therapy games for speech and upper extremity training

8 weeks

Daily home sessions, 4 lab visits for assessments

Follow-up

Participants are monitored for retention of treatment effects

6 weeks

1 visit (in-person)

Treatment Details

Interventions

• Speech and Arm Combined Exergame (Behavioural Intervention)

Trial Overview The study tests home therapy video games designed to improve arm function and speech clarity in children with hemiplegia from cerebral palsy. It involves playing the games daily for 8 weeks and attending four assessment sessions at Rutgers labs.

Participant Groups

Group I: Speech/Arm combined (Group 3) Experimental Treatment 1 Intervention

Participants in Group 3 will play three video games using both voice and hand/arm.

Group II: Speech only (Group 1) Experimental Treatment 1 Intervention

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

Group III: Arm only (Group 2) Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

Dr. Jonathan Holloway

Rutgers, The State University of New Jersey

Chief Executive Officer since 2020

PhD in History from Yale University

Dr. Brian Strom

Rutgers, The State University of New Jersey

Chief Medical Officer since 2014

MD from Rutgers New Jersey Medical School

Findings from Research

Clinicians believe that cycling-based exergames can benefit children with cerebral palsy (CP) and may also be applicable to other pediatric populations, highlighting a positive perspective on their potential use in rehabilitation.

However, barriers such as limited clinician time and misalignment of exergame responsibilities with their roles could hinder the implementation of these interventions in inpatient settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinician perspectives on the implementation of inpatient cycling-based exergames for children with cerebral palsy: A qualitative study. Cardenas, A., Petrevska, M., Biddiss, E., et al.[2022]

The GMFM Ability-Based algorithm significantly reduced the distance between players in a cycling-based video game for youth with cerebral palsy, leading to more balanced and engaging races compared to no balancing, with a dyad spread of 4.6 meters versus 11.9 meters (P < 0.001).

Participants found the game enjoyable and fair, rating it a median score of 4 out of 5 for both fun and fairness, indicating that the algorithm not only improved game balance but also enhanced the overall experience of the players.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ability-Based Balancing Using the Gross Motor Function Measure in Exergaming for Youth with Cerebral Palsy. MacIntosh, A., Switzer, L., Hwang, S., et al.[2018]

Children with cerebral palsy (N=17, average age 9.43 years) engaged in moderate physical activity while playing active video games (AVGs), particularly during dance and boxing games, achieving metabolic equivalents of 3.20 and 3.36 respectively.

Participants reported high enjoyment levels (4.5 out of 5) while playing AVGs, suggesting that these games can be a fun and effective way to promote physical activity and potentially aid in rehabilitation for children with CP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Active video game play in children with cerebral palsy: potential for physical activity promotion and rehabilitation therapies. Howcroft, J., Klejman, S., Fehlings, D., et al.[2022]

Personalised virtual gaming can be an effective and enjoyable therapeutic tool for improving upper extremity function in children with cerebral palsy, as it adapts in real-time to the user's abilities.

While children with cerebral palsy progressed more slowly in certain game modes compared to typically developing children, the overall enjoyment and engagement levels remained high for both groups, indicating the potential for this approach in rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalisation of a virtual gaming system for children with motor impairments: performance and usability. Tresser, S., Kuflik, T., Levin, I., et al.[2023]

Children with cerebral palsy (CP) can maintain or increase their knee extensor muscle activity when using a novel exoskeleton during rehabilitation exercises, indicating that robotic assistance can effectively support their motor capabilities.

The use of the exoskeleton also kept participants engaged, as shown by EEG measurements, and led to significant improvements in knee extension for some participants, suggesting potential for enhancing rehabilitation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exergaming with a pediatric exoskeleton: Facilitating rehabilitation and research in children with cerebral palsy. Bulea, TC., Lerner, ZF., Gravunder, AJ., et al.[2023]

The Personalized In-home eXErgames for Rehabilitation (PIXER) system is a novel 3D exergame platform that allows stroke survivors to engage in home exercise programs, showing feasibility for community-dwelling patients after stroke.

In a clinical pilot study with 10 stroke survivors over 1 month, participants demonstrated positive trends in physical functioning, with 70% completing the program and improvements noted in the Stroke Impact Scale scores, suggesting potential benefits for rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalized 3D exergames for in-home rehabilitation after stroke: a pilot study. Desai, K., Prabhakaran, B., Ifejika, N., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Clinician perspectives on the implementation of inpatient cycling-based exergames for children with cerebral palsy: A qualitative study. [2022]

2. Denmark pubmed.ncbi.nlm.nih.gov

The effects of exergames on muscle strength: A systematic review and meta-analysis. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Ability-Based Balancing Using the Gross Motor Function Measure in Exergaming for Youth with Cerebral Palsy. [2018]

4. England pubmed.ncbi.nlm.nih.gov

An innovative cycling exergame to promote cardiovascular fitness in youth with cerebral palsy. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Active video game play in children with cerebral palsy: potential for physical activity promotion and rehabilitation therapies. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Personalisation of a virtual gaming system for children with motor impairments: performance and usability. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Exergaming with a pediatric exoskeleton: Facilitating rehabilitation and research in children with cerebral palsy. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Personalized 3D exergames for in-home rehabilitation after stroke: a pilot study. [2023]