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

Trial Summary

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 data supports the effectiveness of the treatment Robotic Ankle Assistance + Audiovisual Biofeedback for Cerebral Palsy?

Research shows that biofeedback, including visual and auditory forms, can improve walking patterns in children with cerebral palsy by enhancing step length and ankle movement. Studies also indicate that combining biofeedback with robotic ankle assistance can further enhance walking performance, suggesting this treatment may be effective for improving gait in children with cerebral palsy. ^{1 2 3 4 5}

Is the Robotic Ankle Assistance with Audiovisual Biofeedback safe for humans?

Research on similar biofeedback treatments for children with cerebral palsy suggests that these interventions are generally safe, as they focus on improving walking patterns without reported adverse effects. ^{1 2 3 4 6}

How is the treatment 'Gait Adaptation and Biofeedback' unique for cerebral palsy?

This treatment is unique because it combines robotic ankle assistance with real-time audiovisual biofeedback to improve walking patterns in children with cerebral palsy. Unlike traditional therapies, it uses technology to provide immediate feedback on gait parameters like step length and ankle power, helping to enhance walking performance and symmetry. ^{1 2 3 6 7}

What is the purpose of this trial?

This research aims to evaluate walking function in children with cerebral palsy (CP). The researchers want to understand how children with CP adapt and learn new ways of moving. They have previously found that measuring how a person controls their muscles is important for assessing walking ability and response to interventions. In these studies, they will adjust the treadmill belt speeds and/or provide real-time feedback to evaluate how a child can alter their movement. The feedback will include a wearable exoskeleton that provides resistance to the ankle and audio and visual cues based on sensors that record muscle activity. This research will investigate three goals: first, to measure how children with CP adapt their walking; second, to see if either repeated training or orthopedic surgery can improve adaptation rates; and third, to determine if individual differences in adaptation relate to improvements in walking function after treatment. This research will help develop better treatments to enhance walking capacity and performance for children with CP.

Research Team

Katherine M Steele, PhD

Principal Investigator

University of Washington

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

References

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

Immediate Effects of Immersive Biofeedback on Gait in Children With Cerebral Palsy. [2019]

2. England 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. [2023]

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

Feasibility of Augmenting Ankle Exoskeleton Walking Performance With Step Length Biofeedback in Individuals With Cerebral Palsy. [2021]

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

Effects of biofeedback treatment on gait in children with cerebral palsy. [2022]

5. England pubmed.ncbi.nlm.nih.gov

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

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

Feedback of triceps surae EMG in gait of children with cerebral palsy: a controlled study. [2022]

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

Robotic Gait Training for Individuals With Cerebral Palsy: A Systematic Review and Meta-Analysis. [2018]