Robotic Ankle Assistance + Audiovisual Biofeedback for Cerebral Palsy

Overseen By Alyssa Spomer, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Must not be taking: Botulinum toxin

Disqualifiers: Seizures, Cardiac conditions, others

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

Compensation: Varies

Number of Visits: 12

Duration: 6-8 weeks

36 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help children with cerebral palsy (CP) improve their walking. Researchers are testing how well children with CP can adapt their movement using a treadmill and special feedback tools, such as an ankle exoskeleton and audiovisual biofeedback. They seek to determine if repeated training or surgery can improve walking in these children. The trial is recruiting children with CP who have difficulty walking and have not recently undergone major leg surgery or specific treatments. Participants will either undergo orthopedic surgery or complete treadmill sessions with feedback to assess changes in movement. As an unphased trial, this study offers a unique opportunity for children to potentially enhance their walking abilities through innovative methods.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, it does mention that participants should not have had botulinum toxin injections in the prior 3 months.

What prior data suggests that this robotic ankle assistance and audiovisual biofeedback are safe for children with cerebral palsy?

Research has shown that biofeedback, which provides children with cerebral palsy (CP) real-time information about their movements, is generally well-tolerated. Studies have found that while results can vary, this method helps children improve their walking by better engaging their muscles. Significant reports of harm have not emerged, suggesting it is safe to try.

Robotic ankle resistance, a wearable device that aids walking, also showed promise in previous studies. Research indicates that this assistance can improve walking speed and distance in children with CP. No major safety issues were reported, suggesting it is generally safe to use.

Overall, both biofeedback and robotic ankle resistance treatments appear safe, with no major problems reported in earlier research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for cerebral palsy because they combine cutting-edge technology with personalized feedback to improve walking abilities. Unlike traditional therapies that often rely on physical exercises alone, this approach uses a robotic ankle exoskeleton to provide resistance during walking, helping to strengthen muscles and improve gait. Additionally, the integration of audiovisual biofeedback offers real-time insights into muscle activity, allowing participants to adjust their movements effectively. This innovative method has the potential to enhance rehabilitation outcomes by making therapy more interactive and targeted.

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

Research has shown that audiovisual biofeedback, one of the treatments in this trial, can help people with cerebral palsy (CP) walk better. Studies have found that biofeedback significantly increases ankle strength during walking, improving movement. However, results can vary widely among individuals.

Regarding the robotic ankle support, another treatment option in this trial, studies suggest it can ease walking by reducing the effort needed at the ankle by about 12%. This assistance has increased walking speed, distance, and stride length. Together, these treatments offer hope for helping children with CP improve their walking abilities. ^{1 3 6 7 8}

Who Is on the Research Team?

Katherine M Steele, PhD

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

This trial is for children with bilateral cerebral palsy affecting both legs, who can walk but have some limitations (GMFCS Level II). They shouldn't have had leg surgery or injuries in the last year, botulinum toxin injections in the past 3 months, prior selective dorsal rhizotomy surgery, seizures or heart conditions that limit treadmill use, or current pain impacting walking.

Inclusion Criteria

I have been diagnosed with cerebral palsy affecting both of my legs.

I can walk but have some limitations in more advanced motor skills.

I haven't had any botulinum toxin injections in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 6-8 weeks of multimodal biofeedback training or orthopedic surgery

6-8 weeks

12 sessions (in-person) for biofeedback group

Follow-up

Participants are monitored for changes in gait and adaptation rates after treatment

18 months

Open-label extension (optional)

Participants may continue to receive feedback training to further enhance walking function

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Audiovisual Biofeedback
• Biomotum Spark: Robotic ankle resistance
• Gait Adaptation and Biofeedback

Trial Overview The study tests how a wearable exoskeleton called Biomotum Spark and audiovisual biofeedback affect walking function. It involves adjusting treadmill speeds and providing real-time feedback to help children with CP learn new ways of moving and improve their walking ability through repeated training sessions.

How Is the Trial Designed?

Group I: Orthopedic Surgery Experimental Treatment 1 Intervention

Participants who have been scheduled for lower-extremity, multilevel orthopedic surgery will be assessed before and 9-18 months after surgery to evaluate changes in gait and adaptation rates.

Group II: Audiovisual + Sensorimotor Biofeedback Experimental Treatment 2 Interventions

Participants will complete 12 sessions (20 minutes of walking on a treadmill) over a 6-8 week period while receiving both audiovisual and sensorimotor biofeedback. Sensorimotor biofeedback will be provided with an ankle exoskeleton that provides resistance to ankle plantarflexion during the stance phase of gait. The visual feedback will be provided on a screen with a bar showing real-time muscle activity and the audio feedback will be a sound played when they reach the target level of muscle activity from the plantarflexors.

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

Gillette Children's

Collaborator

Trials

1

Recruited

40+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Gillette Children's Specialty Healthcare

Collaborator

Trials

31

Recruited

8,100+

Northern Arizona University

Collaborator

Trials

36

Recruited

6,300+

Published Research Related to This Trial

Children with cerebral palsy (N=22) showed significant immediate improvements in gait parameters after using avatar-based biofeedback, including a 37.7% increase in ankle power, a 7.4° improvement in knee extension, and a 12.7% increase in step length.

The use of an avatar for biofeedback was preferred over simpler visual aids, suggesting that engaging visual feedback may enhance motor function training, although further research is needed to determine if these improvements can be sustained over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immediate Effects of Immersive Biofeedback on Gait in Children With Cerebral Palsy. Booth, AT., Buizer, AI., Harlaar, J., et al.[2019]

A real-time biofeedback mechanism combined with ankle exoskeleton assistance significantly improved step length by 14% in individuals with cerebral palsy, indicating enhanced walking performance.

The study demonstrated a strong correlation between estimated and actual step length, suggesting that using step length as a target for biofeedback can effectively improve gait mechanics in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Augmenting Ankle Exoskeleton Walking Performance With Step Length Biofeedback in Individuals With Cerebral Palsy. Fang, Y., Lerner, ZF.[2021]

Robotic gait training has positive effects on individuals with cerebral palsy, leading to improvements in walking speed, endurance, and gross motor function, based on a meta-analysis of 10 studies.

The analysis indicated moderate effect sizes for these improvements, suggesting that robotic training can be a beneficial intervention for enhancing mobility in patients classified between levels I and IV of the Gross Motor Function Classification System.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robotic Gait Training for Individuals With Cerebral Palsy: A Systematic Review and Meta-Analysis. Carvalho, I., Pinto, SM., Chagas, DDV., et al.[2018]

In a study of 36 children with spastic cerebral palsy, those who received EMG biofeedback training alongside conventional exercises showed significant improvements in muscle tone and ankle joint range of motion compared to those who only received conventional exercises.

Both groups demonstrated progress in gait function, but the biofeedback group exhibited superior improvements, suggesting that biofeedback treatment can enhance ambulation in children with cerebral palsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of biofeedback treatment on gait in children with cerebral palsy. Dursun, E., Dursun, N., Alican, D.[2022]

A pilot study involving seven children with different types of cerebral palsy showed promising results for using biofeedback in gait training.

The effectiveness of biofeedback appears to be higher in well-motivated children, suggesting that this method may be beneficial for carefully selected patients with cerebral palsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Augmented auditory feedback as an aid in gait training of the cerebral-palsied child. Flodmark, A.[2022]

A computer-assisted biofeedback system targeting the triceps surae muscle group improved gait symmetry and increased ankle power during push-off in children with spastic hemiplegia, showing its potential effectiveness as a treatment.

In contrast, traditional physical therapy improved positive work done by the affected ankle but negatively impacted gait symmetry, indicating that biofeedback may serve as a beneficial complement to standard therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feedback of triceps surae EMG in gait of children with cerebral palsy: a controlled study. Colborne, GR., Wright, FV., Naumann, S.[2022]

A case series involving 10 children with spastic cerebral palsy showed that using vibrotactile EMG-based biofeedback for 4 hours a day over one month was feasible and could enhance sensory feedback during movement.

Six of the children experienced significant improvements in active ankle range of motion during gait, with increases ranging from 8.9% to 51.6%, suggesting this method could be an effective therapeutic tool for improving mobility in children with spastic CP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Prolonged Vibrotactile EMG-Based Biofeedback on Ankle Joint Range of Motion During Gait in Children with Spastic Cerebral Palsy: A Case Series. Bertucco, M., Nardon, M., Mueske, N., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11573209/

Multi-session adaptation to audiovisual and sensorimotor ... This work suggests that individuals with CP have the capacity to adapt their gait using biofeedback, but responses are highly variable.

2. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-023-01279-5

Audiovisual biofeedback amplifies plantarflexor adaptation ... Biofeedback is a promising noninvasive strategy to enhance gait training among individuals with cerebral palsy (CP). Commonly, biofeedback ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0003999318314497

Immediate Effects of Immersive Biofeedback on Gait in ... Participants were able to adapt gait pattern with biofeedback, in an immediate response, reaching large increases in ankle power generation at push-off (37.7%) ...

4. medrxiv.org medrxiv.org/content/10.1101/2025.08.14.25333687v1.full.pdf

Effectiveness of neurofeedback interventions in cerebral ... NF interventions in CP show potential, but their effectiveness remains inconclusive, largely due to heterogeneity in intervention protocols ( ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5237305/

Biofeedback interventions for people with cerebral palsy This review aims to evaluate the effects of biofeedback interventions that have been used towards improving motor performance and motor learning in people with ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6831207/

The effectiveness and safety of electromyography biofeedback ... Results will provide a general overview and evidence concerning the effectiveness and safety of EMG biofeedback therapy for children with CP. The findings of ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2324242623000311

Recent advancements in interventions for cerebral palsy Interventions that show effectiveness include neurological music therapy, aquatic therapy, VR, robotics, ES, CIMT, hippotherapy, and HBO 2 therapy.

8. researchgate.net researchgate.net/publication/325108830_Biofeedback_interventions_for_individuals_with_cerebral_palsy_a_systematic_review

Biofeedback interventions for individuals with cerebral palsy Purpose: The purpose of this study is to evaluate the quality of evidence of biofeedback interventions aimed at improving motor activities ...