Development of a Robotic Ankle Assist Device

Cerebral Palsy Clinical Trial

Official title:

Development of a Robotic Ankle Assist Device to Improve Mobility in Individuals With Movement Disorders

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04516343
• Other study ID #: 1R44HD104328
• Status: Recruiting
• Phase: Phase 1
• Start date: November 1, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2021
• Source: BiOMOTUM, Inc.
• Contact: Zach Lerner, PhD
• Phone: 8145714616
• Email: zachlerner[@]BiOMOTUM.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The overall objectives of this work is to establish feasibility of a robotic ankle assist device (RAAD) to improve mobility in free-living settings and to establish the RAAD as an effective tool to provide increased dose and precision of targeted ankle therapy. The first specific aim is to complete a personal-use feasibility analysis of ankle mobility assistance. It is hypothesized the children will be able to safely walk faster and travel farther in the community when using the RAAD device vs. without the device. The second specific aim is to gather feedback to design and prototype a minimum viable product for use in clinical and community settings. The third specific aim is to quantify the potential for the RAAD system to increase the effectiveness of clinical gait therapy. Individuals with CP will complete three training sessions: RAAD assistance, RAAD resistance and standard of care. Muscle activity and step activity will be measured during each session. It is hypothesized that the RAAD assistance and resistance therapy will improve ankle plantar-flexor muscle activity and treatment session quality compared to traditional physical therapist-guided gait training. The fourth specific aim is to assess the benefits of repeated gait training with RAAD assistance and resistance. Individuals with CP will participate in a 4-week assistance or resistance intervention and mobility outcomes will be quantified pre and post intervention. It is hypothesized that both assistance and resistance training will improve mobility outcomes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: December 31, 2024
• Est. primary completion date: September 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

Inclusion Criteria:

Diagnosis of cerebral palsy. Any sex, race, ethnicity or socioeconomic status. GMFCS level I, II, or II. Ability to walk for at least 6 minutes (assisted or unassisted). Age between 8-18 years. Height/weight/BMI between the 5th - 95th percentile of children with CP.

Able to understand and follow simple directions. Able to complete 5 heel raises with minimal assistance (balance only). At least 20 degrees of passive ankle plantar flexion range of motion.

Exclusion Criteria:

Knee extension or ankle dorsiflexion contractures greater than 15 degrees. Health condition or diagnosis other than CP that would affect safe participation.

Orthopedic surgery completed in the prior 12-months. Current enrollment in a conflicting research study.

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Device:
• Robotic Ankle Assist Device (RAAD)
The RAAD (Robotic Ankle Assist Device) is an intelligent, powered ankle device designed to increase independence, mobility, and deliver gait training to children with movement disorders, such as CP

Locations

Country	Name	City	State
United States	Northern Arizona University	Flagstaff	Arizona

Sponsors (5)

Lead Sponsor	Collaborator
BiOMOTUM, Inc.	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Gillette Children's Specialty Healthcare, Northern Arizona University, Shirley Ryan AbilityLab

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in preferred walking speed	How fast someone prefers to walk	6 minutes pre/post
Primary	PF activity	Number of steps with mean late stance (i.e. propulsive) ankle plantar flexor activity above pre-session baseline average activity of 5 heel raises	30 minute session
Primary	Change in lower extremity muscle activity similarity to the average unimpaired activity pattern	Similarity of muscle activity to the average unimpaired activity pattern calculated via cross-correlation coefficient	6 minutes pre/post
Secondary	Ankle muscle co-contraction	Number of steps with mean stance phase ankle co-contraction below pre-session baseline	30 minute session
Secondary	Qualitative therapist assessment of session quality, participant movement, and device usability via questionnaire	Qualitative therapist assessment of session quality, participant movement quality, and device usability via questionnaire	At the end of the study visit
Secondary	Minimum age and function level required to don and operate the device without direct parent help	Minimum age and function level required to don and operate the device without direct parent help	At the end of the study visit
Secondary	Participant questionnaire of exertion, ankle muscle soreness, device usability, comfort, and ease of don/doffing	Qualitative participant assessment of exertion, ankle muscle soreness, device usability, comfort, and ease of don/doffing via questionnaire	At the end of the study visit
Secondary	COT	Metabolic cost of transport	baseline and post intervention
Secondary	6MWT	Six-minute walk test	6 minutes pre/post
Secondary	TUG	Timed up-and-go test	2 minutes pre/post
Secondary	Gait kinetics	Positive ankle power, and distribution of positive joint power across the lower extremity measured in Watts	6 minutes pre/post
Secondary	Gait kinematics	Lower extremity joint angles measured in degrees	6 minutes pre/post
Secondary	VR	Stride-to-stride variability of lower-extremity muscle activity calculated via variance ratio	6 minutes pre/post
Secondary	VAF1	Variance accounted for by the first muscle synergy	6 minutes pre/post
Secondary	Plantar-flexor muscle strength via hand held dynamometry	Plantar-flexor muscle strength via hand held dynamometry	1 minutes pre/post
Secondary	Gross motor function measure scale 66	Gross motor function measure scale 66, min score = 0, max score = 66, high score is better	20 minutes pre/post