Robotic Ankle Therapy for Cerebral Palsy

Overseen By Zach Lerner, PhD

Age: < 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Northern Arizona University

Disqualifiers: Other treatments, Other conditions, Recent surgery

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

Compensation: Varies

Number of Visits: 2

Duration: 12 weeks

36 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new robotic ankle devices to help children with cerebral palsy (CP) improve their walking. Researchers compare the effects of robotic ankle resistance and assistance (Biomotum Spark) against standard therapies to determine which works best. They examine how these devices might enhance muscle control, gait, and overall mobility. Children with CP who have ankle-related walking issues and can walk at least 30 feet might be suitable candidates. The study aims to find better ways to boost movement and endurance during everyday activities. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this innovative therapy.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications, but it does mention that you cannot have concurrent treatment other than those assigned during the study. It's best to discuss your specific medications with the trial coordinators.

What prior data suggests that this robotic ankle therapy is safe for children with cerebral palsy?

Research shows that robotic ankle devices, such as the Biomotum Spark, have been tested to assist people with cerebral palsy. Studies have found that these devices can improve walking and ease movement. Initial tests of the Biomotum Spark's robotic ankle support demonstrated that users experienced better mobility and found walking on various surfaces, like flat ground and stairs, less tiring.

Regarding the robotic ankle's resistance feature, past research focused on ensuring its safety and effectiveness. Tests aimed to enhance overall walking and movement. These tests found that the devices were generally well-received, with no major safety issues.

Since this trial is in the early stages, it primarily assesses the treatment's safety and how well people adapt to it. At this point, researchers closely monitor any new treatment to ensure it doesn’t cause harm, but there is limited information on long-term effects. Participants can expect a thorough evaluation to ensure safety. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these robotic ankle therapies for cerebral palsy because they offer a new approach to improving mobility. Unlike traditional physical therapy and ankle braces, which primarily support or stabilize the ankle, the Biomotum Spark device provides both adaptive assistance and resistance during movement. This means it can dynamically help or challenge the muscles, potentially enhancing muscle strength and coordination more effectively. By targeting specific muscle groups with precision, these treatments aim to improve walking ability in ways that standard treatments may not.

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

Research shows that robotic ankle support can significantly improve mobility for people with cerebral palsy. In this trial, participants may use the Biomotum Spark device, which offers both support and resistance. Studies have found that this technology eases walking and reduces fatigue by lowering ankle strain by 12%, especially when walking uphill. Additionally, robotic ankle resistance training can enhance walking speed, distance, and step length. This approach helps build muscle strength and improve walking patterns. The Biomotum Spark device aims to enhance strength and movement skills, showing promising early results for children with CP. ^{1 3 6 7 8}

Who Is on the Research Team?

Zach F Lerner, PhD

Principal Investigator

Northern Arizona University

Are You a Good Fit for This Trial?

This trial is for children aged 8-18 with Cerebral Palsy who have trouble walking due to ankle issues. They must be able to follow simple instructions and walk at least 30 feet, with or without help. Kids who've had other treatments or surgeries within the last 6 months can't join.

Inclusion Criteria

I can follow simple instructions and walk at least 30 feet, with or without help.

I can point my toes downward at least 20 degrees.

I am between 8 and 21 years old with CP and ankle problems affecting my walk.

Exclusion Criteria

I have not had surgery in the last 6 months.

Concurrent treatment other than those assigned during the study

A condition other than CP that would affect safe participation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo targeted ankle resistance gait training and adaptive ankle assistance for 12 weeks

12 weeks

2 visits/week

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ankle foot orthosis
• Biomotum Spark: Robotic ankle assistance
• Biomotum Spark: Robotic ankle resistance
• Standard gait training
• Standard physical therapy
• Standard walking

Trial Overview The study tests if special gait training with robotic ankle assistance or resistance improves walking in kids with CP better than standard therapy. It checks their muscle control and mobility after four and twelve weeks, comparing it to regular physical therapy and walking aids.

How Is the Trial Designed?

Group I: Standard gait training (control) Experimental Treatment 1 Intervention

We will conduct a randomized controlled trial (treatment vs. control) to compare functional outcomes following bilateral targeted ankle resistance training (2 visits/week for 12 weeks) vs. dose-matched standard functional gait training.

Group II: Passive brace assisted ambulation Experimental Treatment 1 Intervention

We will compare task capacity and performance with adaptive ankle assistance vs. standard ankle foot orthoses and vs. shod (no ankle aid).

Group III: No ankle aid ambulation Experimental Treatment 1 Intervention

We will compare task capacity and performance with adaptive ankle assistance vs. standard ankle foot orthoses and vs. shod (no ankle aid).

Group IV: Device resisted gait training (treatment) Experimental Treatment 1 Intervention

We will conduct a randomized controlled trial (treatment vs. control) to compare functional outcomes following bilateral targeted ankle resistance training (2 visits/week for 12 weeks) vs. dose-matched standard functional gait training.

Group V: Device assisted ambulation Experimental Treatment 1 Intervention

We will compare task capacity and performance with adaptive ankle assistance vs. standard ankle foot orthoses and vs. shod (no ankle aid).

Group VI: Comparison to Standard PT (within subjects control) Experimental Treatment 1 Intervention

We will use a within-subject repeated measures design to compare both gait training groups to matched standard physical therapy.

Who Is Running the Clinical Trial?

Northern Arizona University

Lead Sponsor

Trials

36

Recruited

6,300+

University of Washington

Collaborator

Trials

1,858

Recruited

2,023,000+

Gillette Children's Specialty Healthcare

Collaborator

Trials

31

Recruited

8,100+

Published Research Related to This Trial

A study involving 28 children with cerebral palsy showed significant improvements in ankle range of motion, strength, mobility, and balance after a 6-week robotic rehabilitation program, indicating the efficacy of this intervention.

The results from the clinic cohort were comparable to those from a previously published research cohort, demonstrating that robotic rehabilitation can be effectively implemented in a clinical setting for enhancing functional outcomes in children with cerebral palsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical application of a robotic ankle training program for cerebral palsy compared to the research laboratory application: does it translate to practice? Sukal-Moulton, T., Clancy, T., Zhang, LQ., et al.[2021]

The ATLAS2030 exoskeleton significantly improved range of motion (ROM), strength, and reduced spasticity in three children with cerebral palsy after one month of robot-assisted gait training, indicating its potential as an effective rehabilitation tool.

All participants, aged around 8 years, were able to complete the training sessions, suggesting that the exoskeleton is user-friendly and can be integrated into therapy for children with varying levels of motor function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ATLAS2030 Pediatric Gait Exoskeleton: Changes on Range of Motion, Strength and Spasticity in Children With Cerebral Palsy. A Case Series Study. Delgado, E., Cumplido, C., Ramos, J., et al.[2021]

The alpha-prototype of a novel pediatric ankle robot was developed to assist in the recovery of ankle function in children aged 5 to 8 years with cerebral palsy, indicating a targeted approach to rehabilitation for this specific age group and condition.

Pilot testing of the robot will begin at multiple children's hospitals, and initial data with healthy children suggests that the device has promising characteristics for effective therapy, following established design principles for robotic rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pediatric anklebot. Krebs, HI., Rossi, S., Kim, SJ., et al.[2012]

Robot-assisted gait training, especially when combined with motivational instructions from a therapist, significantly increases muscle activity in children with motor impairments compared to training without instructions.

The study found that robotic-assisted gait training can produce more physiological muscle activation patterns than unassisted treadmill walking, suggesting it may promote restorative mechanisms in movement rather than just compensatory ones.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Leg surface electromyography patterns in children with neuro-orthopedic disorders walking on a treadmill unassisted and assisted by a robot with and without encouragement. Aurich Schuler, T., Müller, R., van Hedel, HJ.[2021]

A systematic review of 13 studies involving 322 participants found that lower limb robotic exoskeletons did not show significant improvements in gait or balance compared to conventional therapy, as measured by tests like the 6-Minute Walk Test and Berg Balance Scale.

While there were no severe adverse events reported, an 11.5% dropout rate suggests some participants may have faced challenges with the robotic therapy, indicating that further research is needed to explore its effectiveness and safety in specific subgroups of individuals with acquired brain injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do powered over-ground lower limb robotic exoskeletons affect outcomes in the rehabilitation of people with acquired brain injury? Postol, N., Marquez, J., Spartalis, S., et al.[2020]

In a six-week study involving 20 multiple sclerosis patients, robot-assisted body-weight-supported treadmill training significantly improved the torque of both hip and knee joint muscles, enhancing lower limb muscle power.

This training led to better walking ability for patients, allowing them to walk with less effort and reduced reliance on caregivers, suggesting its potential as an effective rehabilitation method for gait dysfunction in MS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robot-Assisted Body-Weight-Supported Treadmill Training in Gait Impairment in Multiple Sclerosis Patients: A Pilot Study. Łyp, M., Stanisławska, I., Witek, B., et al.[2019]

A study involving 62 non-ambulatory chronic patients with acquired brain injury found that both Lokomat and Walkbot robotic gait training systems significantly improved functional ambulation and balance after combined therapy sessions.

There were no significant differences in the effectiveness of Lokomat and Walkbot in enhancing gait rehabilitation, suggesting that both systems are equally promising for helping patients regain mobility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparisons between Locomat and Walkbot robotic gait training regarding balance and lower extremity function among non-ambulatory chronic acquired brain injury survivors. Lee, HY., Park, JH., Kim, TW.[2023]

Children with cerebral palsy had mixed feelings about robotic gait training with the Lokomat, often feeling uncertain about what to expect and sometimes anxious about participating, indicating a need for better engagement strategies in rehabilitation.

Despite the potential benefits of robotic training, children did not express a strong desire to achieve 'normal' walking patterns, suggesting that rehabilitation goals should align more closely with children's personal expectations and experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What is it like to walk with the help of a robot? Children's perspectives on robotic gait training technology. Phelan, SK., Gibson, BE., Wright, FV.[2018]

This study is a randomized controlled trial comparing robotic-assisted gait training (RAGT) to traditional physiotherapy (PT) in children with cerebral palsy, aiming to assess improvements in gross motor function and walking endurance over 16 weeks with twice-weekly sessions.

The trial will evaluate key outcomes such as gross motor functional ability and walking distance, providing valuable insights into the effectiveness of RAGT compared to standard PT, which could influence rehabilitation practices for children with CP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of a robotic-assisted gait training program with a program of functional gait training for children with cerebral palsy: design and methods of a two group randomized controlled cross-over trial. Hilderley, AJ., Fehlings, D., Lee, GW., et al.[2022]

The Rutgers Ankle CP, a new rehabilitation device, was tested on a 7-year-old boy with cerebral palsy over 36 sessions, showing significant improvements in ankle strength, motor control, and gait function.

The training led to enhanced overall function and quality of life, surpassing minimal clinical importance, suggesting that this device could be beneficial for children with cerebral palsy, although further studies with more participants are needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ankle control and strength training for children with cerebral palsy using the Rutgers Ankle CP: a case study. Cioi, D., Kale, A., Burdea, G., et al.[2013]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10922449/

Effects of ankle exoskeleton assistance and plantar ... Compared to incline walking without assistance or biofeedback, ankle assistance alone reduced the peak biological ankle moment by 12% (p < 0.001) ...

2. biomotum.com biomotum.com/researchers

FOR RESEARCH | Biomotum Inc. | United States The Biomotum SPARK is an untethered, go-anywhere research platform which provides dorsiflexion and plantarflexion assistance or resistance.

3. withpower.com withpower.com/trial/phase-1-cerebral-palsy-3-2022-1db25?condition=cerebral+palsy&overallStatus=Recruiting&hasNoPlacebo=false

Robotic Ankle Therapy for Cerebral Palsy The Biomotum Spark robotic ankle therapy is unique because it provides both assistance and resistance to the ankle, which can help improve strength and motor ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04516343

Development of a Robotic Ankle Assist Device | ... Individuals with CP will participate in a 4-week assistance intervention and mobility outcomes will be quantified pre and post intervention. The second specific ...

5. biomotum.com biomotum.com/home

Robotics for Rehabilitation | Biomotum Inc. | United States The Biomotum SPARK delivers precise and effective rehabilitation to individuals with cerebral palsy, stroke, and other neurological conditions. Increase ...

6. sralab.org sralab.org/research/labs/max-nader-rto/projects/complete-evaluation-robotic-trainer-children-cerebral-palsy

Evaluation of a Robotic Trainer for Children with Cerebral ... The purpose of this study to determine the safety and benefit of the BiOMOTUM RAAD robotic exoskeleton device to provide resistance as a tool ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11309519/

Walking on Real-world Terrain with an Ankle Exoskeleton ... Tested on an outdoor walking route with level, sloped, and stair terrain, robotic assistance resulted in a 15–18% (p = 0.013–0.026) reduction in estimated ...

8. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/43/NCT04516343/ICF_002.pdf

Chief Science O icer NCT04516343 6/10/2024 Title of Research Study: Development of robotic ankle assist device to improve mobility in individuals with movement disorders. Investigator Team Contact ...