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Robotic Ankle Assistance + Audiovisual Biofeedback for Cerebral Palsy

N/A

Recruiting

Led By Katherine M Steele, PhD

Research Sponsored by University of Washington

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline at 1-month after intervention.

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to investigate how children with CP adapt their walking and see if treatments can improve it. A wearable exoskeleton and audio/visual cues will be used to measure and assess progress.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort from wearing the exoskeleton device, fatigue due to exercise on a treadmill with resistance at the ankle provided by the device, and possible frustration or stress from adapting to audiovisual biofeedback during movement.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline at 1-month after intervention.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline at 1-month after intervention.

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline at 1-month after intervention. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Dynamic Motor Control During Walking (Walk-DMC)

Change in Gait Deviation Index (GDI)

Change in Gross Motor Function Measure - 66 (GMFM-66) Parts D & E

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Sensorimotor BiofeedbackExperimental Treatment1 Intervention

Participants will complete 12 sessions (20 minutes of walking on a treadmill) over a 6-8 week period while receiving sensorimotor biofeedback with an ankle exoskeleton that provides resistance to ankle plantarflexion during the stance phase of gait.

Group II: Audiovisual BiofeedbackExperimental Treatment1 Intervention

Participants will complete 12 sessions (20 minutes of walking on a treadmill) over a 6-8 week period while receiving audiovisual biofeedback based on the muscle activity of their ankle plantarflexors. 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.

Group III: Audiovisual + Sensorimotor BiofeedbackExperimental Treatment2 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.

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