Wheelchair Skills Training for Cerebral Palsy

Overseen By Lisa Kenyon, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Grand Valley State University

Disqualifiers: Cannot sit for 60 minutes, Own power wheelchair, Others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 8 weeks

16 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if an 8-week power wheelchair skills training using the IndieTrainer system can help children with severe cerebral palsy improve their power wheelchair use. The study will assess whether the training enhances wheelchair skills immediately after the program and again after 8 weeks. Children with severe cerebral palsy who cannot walk or use a manual wheelchair independently, but can understand basic cause and effect (such as moving the wheelchair with a joystick), might be suitable candidates for this trial. As an unphased trial, it offers a unique opportunity for children to potentially enhance their mobility skills and contribute to valuable research.

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 this wheelchair skills training is safe for children with cerebral palsy?

Research has shown that the IndieTrainer system helps children with cerebral palsy enhance their skills in using power wheelchairs. However, specific safety information for this system is not available. Since this trial does not involve drugs, the safety details might not be as comprehensive as those in drug trials.

Generally, training for power wheelchair skills is considered safe and aims to improve movement and participation. The system uses video-game modules and traditional training, methods familiar to many children. This similarity suggests the training is likely manageable, as it resembles normal learning and play activities.

Even without specific safety reports, knowing that this training mirrors regular therapy activities might reassure potential participants. Discussing any concerns with the research team before joining the trial is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the IndieTrainer system for power wheelchair skills training because it offers a tailored, evidence-based approach to enhance mobility for individuals with cerebral palsy. Unlike traditional training methods, which may not be as structured or personalized, the IndieTrainer system provides a comprehensive, 8-week program designed specifically to improve wheelchair handling skills. This targeted training aims to empower users by boosting their confidence and independence, potentially leading to a better quality of life.

What evidence suggests that the IndieTrainer system is effective for improving powered wheelchair skills in children with cerebral palsy?

Research has shown that the IndieTrainer system helps children with cerebral palsy improve their skills in using power wheelchairs. This system uses fun, game-like training modules, making learning easier and more enjoyable for children. In this trial, participants in the Experimental Group will receive the 8-week evidence-based PWC skills training using the IndieTrainer system. Specifically, some children demonstrated better movement and increased involvement in activities after using the IndieTrainer. This training can boost their independence and help them participate in everyday activities. Overall, it offers promising results for children who need to learn powered wheelchair skills. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for children with severe cerebral palsy who may benefit from using a powered wheelchair (PWC) for mobility and independence. To join, they must be able to participate in an 8-week training program and follow-up assessments.

Inclusion Criteria

I can show cause and effect skills in powered mobility at a Phase 4 level or higher.

I cannot walk or move a wheelchair on my own as confirmed by a health professional.

I have severe cerebral palsy (difficulty moving and keeping balance).

Exclusion Criteria

My wheelchair or stroller is not compatible with the IndieTrainer System.

I already use a power wheelchair prescribed for me.

A health professional has deemed power wheelchair training unsafe for me due to my medical history.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an 8-week PWC skills training intervention using the IndieTrainer System

8 weeks

Weekly sessions

Follow-up

Participants are monitored for improvements in PWC skills capacity and performance 8 weeks after the intervention

8 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Power wheelchair skills training using the IndieTrainer system

Trial Overview

The study is testing if special training using the IndieTrainer system over 8 weeks can help these kids get better at controlling their power wheelchairs. It's a randomized trial where some will receive this training while others won't, to compare outcomes.

How Is the Trial Designed?

Group I: Group A: Experimental Group Experimental Treatment 1 Intervention

Group A: The Experimental Group will receive the 8-week evidence-based PWC skills training using the IndieTrainer System following T0 baseline testing

Group II: Group B: Wait List Control Group Active Control 1 Intervention

Group B: The Wait List Control Group will receive the 8-week evidence-based PWC skills training using the IndieTrainer System following T2 testing

Power wheelchair skills training using the IndieTrainer system is already approved in United States, European Union for the following indications:

Approved in United States as IndieTrainer system for:

• Severe Cerebral Palsy

Approved in European Union as IndieTrainer system for:

• Severe Cerebral Palsy

Who Is Running the Clinical Trial?

Grand Valley State University

Lead Sponsor

Trials

13

Recruited

8,700+

Published Research Related to This Trial

A study involving 28 clinicians revealed that providing wheelchair skills training for children involves considering a wide range of factors, with 1246 distinct factors identified and categorized using the International Classification of Functioning, Disability and Health (ICF) system.

Most factors (42.25%) related to the Activities and Participation domain, indicating that effective wheelchair skills training requires a comprehensive understanding of not just motor abilities, but also the child's overall participation in daily activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors clinicians consider when providing pediatric wheelchair skills training: a modified think aloud study. Kenyon, LK., McNally, D., Ray, J., et al.[2023]

A structured short-term training intervention significantly improved transfer skills in pediatric wheelchair users, with the intervention group scoring an average of 9.06 compared to 7.15 in the control group, indicating effective training outcomes.

The improvements in transfer skills observed in children were comparable to those seen in adult wheelchair users, suggesting that similar training methods can be beneficial across age groups, potentially aiding in long-term upper extremity preservation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term influence of transfer training among full time pediatric wheelchair users: A randomized trial. Rice, LA., Dysterheft, JL., Sanders, E., et al.[2018]

A feasibility study is being conducted with 32 older adults with mild to moderate cognitive impairment to evaluate a powered-wheelchair training program that uses errorless learning strategies and shared control technology.

The program aims to improve powered-wheelchair skills, suggesting that this method could effectively address the learning needs of older adults who struggle with traditional training methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility RCT protocol evaluating a powered-wheelchair training program for older adults. Smith, EM., Miller, WC., Mortenson, WB., et al.[2019]

The IndieTrainer system, which combines a mobility device with gamified training, aims to improve powered wheelchair skills in children with cerebral palsy, and is being tested in a small-scale study involving 25 child-parent dyads over three weeks.

This innovative system is designed to support early learners who may not yet grasp cause and effect, making it a unique tool for enhancing mobility skills in children with CP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The IndieTrainer system: a clinical trial protocol exploring use of a powered wheelchair training intervention for children with cerebral palsy. Kenyon, LK., Farris, J., Veety, L., et al.[2023]

A study involving 10 participants (5 experienced powered wheelchair users and 5 expert clinicians) identified 110 distinct skills and abilities necessary for safe indoor powered wheelchair use, highlighting the complexity of this task.

The research revealed that about 50% of these skills are mental functions, and it emphasized the need for training programs to cover a wide range of skills and knowledge, including understanding oneself, the environment, the wheelchair, and the specific tasks involved.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding the task demands for powered wheelchair driving: a think-aloud task analysis. Smith, EM., Mortenson, WB., Mihailidis, A., et al.[2022]

In a study of 10 children with severe dyskinetic cerebral palsy using power wheelchairs, dystonia was found to be significantly more prevalent and severe (83.6%) compared to choreoathetosis (34.4%), indicating that dystonia has a greater impact on mobility performance.

The study revealed strong correlations between the severity of arm dystonia and mobility performance, suggesting that as children gain more experience with driving the wheelchair, they develop strategies to manage the effects of their movements on performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dystonia and choreoathetosis presence and severity in relation to powered wheelchair mobility performance in children and youth with dyskinetic cerebral palsy. Bekteshi, S., Konings, M., Nica, IG., et al.[2021]

A survey of Irish health professionals revealed that while wheelchair skills training is commonly provided to new users, it primarily focuses on basic skills like transfers and simple mobility, with advanced skills being taught infrequently.

There is a strong consensus among respondents for the need to develop standardized training programs and continued education in advanced wheelchair skills to enhance the confidence and knowledge of service providers, ultimately improving mobility for wheelchair users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A cross-sectional survey investigating wheelchair skills training in Ireland. Mathis, K., Gowran, RJ.[2023]

The Hybrid Course developed by the International Society of Wheelchair Professionals significantly improved wheelchair service knowledge among participants, with an average score increase of 10.84 points on the ISWP Wheelchair Service Provision-Basic Test after training.

The course met quality standards as evaluated by external reviewers, demonstrating its effectiveness and potential for better training of wheelchair providers, which is crucial for reducing health risks in wheelchair users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Hybrid Course on Wheelchair Service Provision for clinicians in international contexts. Burrola-Mendez, Y., Goldberg, M., Gartz, R., et al.[2019]

A wheelchair skills training program significantly improves manual wheelchair skills capacity in the short term, with a 13.26% increase in skills test scores compared to control groups in randomized controlled trials and a 23.44% increase in non-randomized studies.

While the training shows short-term benefits, the long-term effectiveness of manual wheelchair skills training and the effectiveness of powered wheelchair skills training remain unclear, with insufficient evidence to support lasting advantages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and safety of wheelchair skills training program in improving the wheelchair skills capacity: a systematic review. Tu, CJ., Liu, L., Wang, W., et al.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10687311/

The IndieTrainer System: A Clinical Trial Protocol Exploring ...

The IndieTrainer system, comprised of both a mobility device and gamified training modules, was developed to aid powered wheelchair (PWC) skills acquisition ...

2.

clinicaltrials.gov

clinicaltrials.gov/ct2/show/NCT05473182

IndieTrainer: Enabling Individuals With Cerebral Palsy to ...

The IndieTrainer system is designed to allow a child to practice power wheelchair skills as part of the video-game modules or as part of more traditional power ...

3.

withpower.com

withpower.com/trial/wheelchair-skills-training-for-cerebral-palsy-10a33

Wheelchair Skills Training for Cerebral Palsy

What data supports the effectiveness of the treatment Power wheelchair skills training using the IndieTrainer system? Research suggests that powered ...

4.

scholarworks.indianapolis.iu.edu

scholarworks.indianapolis.iu.edu/bitstreams/4b67a3da-fd27-405d-99f4-7f053b35ba36/download

POWER WHEELCHAIR SKILLS TRAINING

Outcome. Pre-test. Post-test. Participation frequency. 5.4/7. 4.7/7. Activity involvement. 3.6/5. 2.8/5. Desired change in participation (%).

5.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/10.1111/dmcn.15597

Effectiveness of wheeled mobility skill interventions in ...

Wheeled mobility interventions showed promising beneficial effects on wheeled mobility, activity and participation, and quality of life for children and young ...

6.

researchgate.net

researchgate.net/publication/371176848_The_IndieTrainer_system_a_clinical_trial_protocol_exploring_use_of_a_powered_wheelchair_training_intervention_for_children_with_cerebral_palsy

The IndieTrainer system: a clinical trial protocol exploring ...

Impact: The IndieTrainer system allows children to explore and use power mobility in their own manual wheelchair and was designed to meet the ...