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Development of a Robotic Ankle Assist Device

Primary Purpose

Cerebral Palsy

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Robotic Ankle Assist Device (RAAD)
Sponsored by
BiOMOTUM, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy

Eligibility Criteria

8 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Northern Arizona UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

User testing

Therapist-guided training

Assistance training

Therapist supervised resistance training

Parent supervised resistance training

Arm Description

Two sessions of user-centric testing.

Therapist-guided gait training with the RAAD.

Assistance training with the RAAD

Resistance training with the RAAD under therapist supervision.

Resistance training under parent supervision.

Outcomes

Primary Outcome Measures

Change in preferred walking speed
How fast someone prefers to walk
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
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

Secondary Outcome Measures

Ankle muscle co-contraction
Number of steps with mean stance phase ankle co-contraction below pre-session baseline
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
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
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
COT
Metabolic cost of transport
6MWT
Six-minute walk test
TUG
Timed up-and-go test
Gait kinetics
Positive ankle power, and distribution of positive joint power across the lower extremity measured in Watts
Gait kinematics
Lower extremity joint angles measured in degrees
VR
Stride-to-stride variability of lower-extremity muscle activity calculated via variance ratio
VAF1
Variance accounted for by the first muscle synergy
Plantar-flexor muscle strength via hand held dynamometry
Plantar-flexor muscle strength via hand held dynamometry
Gross motor function measure scale 66
Gross motor function measure scale 66, min score = 0, max score = 66, high score is better

Full Information

First Posted
August 13, 2020
Last Updated
May 7, 2021
Sponsor
BiOMOTUM, Inc.
Collaborators
Northern Arizona University, Gillette Children's Specialty Healthcare, Shirley Ryan AbilityLab, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT04516343
Brief Title
Development of a Robotic Ankle Assist Device
Official Title
Development of a Robotic Ankle Assist Device to Improve Mobility in Individuals With Movement Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
September 15, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BiOMOTUM, Inc.
Collaborators
Northern Arizona University, Gillette Children's Specialty Healthcare, Shirley Ryan AbilityLab, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
This study has four experiments. In experiment I, participants will be recruited to complete user-centric device testing. In experiment 2, participants will be recruited to complete a study to determine effectiveness of the device during clinical gait therapy. In experiment three, participants will be recruited to complete gait training with the RAAD under assistance.In experiment four, participants will be recruited to complete gait training with the RAAD under resistance either (1) always under therapist supervision, or (2) with one therapist-supervised and two parent- supervised sessions per week.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zach Lerner, PhD
Phone
8145714616
Email
zachlerner@BiOMOTUM.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ray Browning, PhD
Phone
9713306800
Email
ray@BiOMOTUM.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ray Browning, PhD
Organizational Affiliation
BiOMOTUM, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northern Arizona University
City
Flagstaff
State/Province
Arizona
ZIP/Postal Code
86011
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zachary Lerner, PhD
Phone
814-571-4616
Email
zachlerner@biomotum.com
First Name & Middle Initial & Last Name & Degree
Zachary Lerner, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Development of a Robotic Ankle Assist Device

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