Exergame for Cerebral Palsy

(SPACE Trial)

Overseen By Qinyin Qiu, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Rutgers, The State University of New Jersey

Disqualifiers: Severe vision impairment, Dyskinetic CP, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 8 weeks

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new home therapy video games designed to help children with cerebral palsy improve the use of their weaker arm and enhance speech clarity. Researchers aim to assess the impact of these games on speech, hand movement, and brain activity. The trial includes three groups: one using both voice and hand/arm, one using voice only, and another using the impaired hand/arm only. It suits children aged 8-17 with cerebral palsy who use speech to communicate and have mild to moderate speech and movement challenges. As an unphased trial, this study offers participants a unique opportunity to contribute to innovative research that could enhance therapy options for cerebral palsy.

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 prior data suggests that these therapy games are safe for children with cerebral palsy?

Research has shown that exergames, like those in this trial, are generally well-received by children with cerebral palsy. Studies have found that these games can improve muscle strength and movement without causing serious side effects. Other research has linked exergames to positive effects on muscle control and reducing tight or stiff muscles in children with cerebral palsy. This type of therapy is often considered safe because it uses fun, interactive methods that gently engage both the body and mind. Although specific data on side effects for this trial is not available, similar treatments have been well-tolerated in past studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Exergame for Cerebral Palsy because it's a fresh approach that combines physical and speech therapy through interactive video games. Unlike traditional therapies that often focus on either physical or speech improvements separately, this method encourages simultaneous use of voice and hand movements, which could enhance coordination and engagement. The innovative use of gaming technology makes the therapy more enjoyable and motivating for participants, potentially leading to better adherence and outcomes. This approach could offer a fun and effective alternative to standard therapies like physical therapy and speech therapy, which can sometimes be repetitive and less engaging.

What evidence suggests that this trial's treatments could be effective for cerebral palsy?

Research shows that exercise games, or "exergames," can strengthen muscles in kids with cerebral palsy, especially when combined with regular care. This trial will evaluate different exergame approaches: one group will use games focusing on both speaking and arm movements, another group will use games focusing on speech only, and a third group will use games focusing on arm movements only. A review of virtual reality-based exergames found they aid rehabilitation for children with cerebral palsy. These game-like therapies have improved both upper body movement and speech clarity in these children. These findings suggest that exergames could enhance movement and speech in young people with cerebral palsy. ^{1 2 3 6 7}

Who Is on the Research Team?

Young Hwa M Chang, PhD, CCC-SLP

Principal Investigator

Rutgers University

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Speech and Arm Combined Exergame

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Exergames can significantly improve upper and lower limb muscle strength in various populations compared to usual care interventions, but they do not show a significant effect on muscle strength in middle-aged and older adults when compared to non-exercise control groups.

In children with hemiplegic cerebral palsy, combining usual care with exergames leads to greater improvements in handgrip strength, highlighting the potential of exergames as a beneficial addition to traditional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of exergames on muscle strength: A systematic review and meta-analysis. Viana, RB., de Oliveira, VN., Dankel, SJ., et al.[2021]

The six-week internet-platform exergame cycling program led to significant improvements in cardiovascular fitness, as measured by the GMFCS III-specific shuttle run test, in eight youth with bilateral spastic cerebral palsy.

While the primary outcome showed positive results, secondary outcomes related to health-related quality of life and other fitness measures did not show significant changes, indicating that further research is needed to explore the full benefits of this intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An innovative cycling exergame to promote cardiovascular fitness in youth with cerebral palsy. Knights, S., Graham, N., Switzer, L., et al.[2018]

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]

Citations

1. trialx.com trialx.com/clinical-trials/listings/296058/speech-and-arm-combined-exergame/

Speech and Arm Combined Exergame | Clinical Research ... Overview. The purpose of this study is to develop innovative home therapy games to train the weak arm and improve speech intelligibility ...

2. withpower.com withpower.com/trial/exergame-for-cerebral-palsy-b20f3

Exergame for Cerebral Palsy (SPACE Trial) Research shows that exergames can improve muscle strength in children with cerebral palsy when added to usual care, suggesting potential benefits for treatments ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10672287/

Application of Virtual Reality-Assisted Exergaming on the ... Application of virtual reality-assisted exergaming on the rehabilitation of children with cerebral palsy: a systematic review and meta-analysis.

4. centerwatch.com centerwatch.com/clinical-trials/listings/condition/480/cerebral-palsy?activelyRecruiting=false&page=146

Cerebral Palsy Clinical Research Trials 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 ...

5. cpresource.org cpresource.org/topic/clinical-trials-geographic-location

Clinical Trials by Geographic Location Purpose: The purpose of this study is to develop innovative home therapy games to train the weak arm and improve speech intelligibility (clarity) of children ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11655094/

Rehabilitation With Exergames in Individuals With Moderate to ... In this report, we describe the effects of a therapeutic exercise protocol with exergames (TEP-Exergame) on postural control and spasticity of two young adults.

7. mdpi.com mdpi.com/2077-0383/12/22/7091

Application of Virtual Reality-Assisted Exergaming on the ... Conclusions: Our findings suggest that VR-assisted exergaming may have some advantages over conventional rehabilitation in improving CP children's functioning ...