Evaluating Wearable Robotic Assistance on Gait

NCT ID: NCT04119063

Last Updated: 2024-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-08
• Study Completion Date: 2022-11-20

Brief Summary

The overarching goal of this study is to improve mobility in individuals with movement disorders through advances in wearable assistance (i.e. powered orthoses).

Detailed Description

Individuals with cerebral palsy completed high frequency over-ground gait training (4x/week for 1 week) with ankle exoskeleton assistance, and then, after a 1 year washout period, the same participants will complete low frequency over-ground gait training (2x/week for 2 weeks).

Conditions

Cerebral Palsy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Gait Training with Exoskeleton Assistance

Gait training with ankle exoskeleton assistance. All participants received high frequency gait training followed by a washout period then low frequency gait training.

Group Type: EXPERIMENTAL

powered orthosis

Intervention Type: DEVICE

Novel powered leg brace to provide assistance during walking.

Interventions

powered orthosis

Novel powered leg brace to provide assistance during walking.

Intervention Type: DEVICE

Other Intervention Names

exoskeleton

Eligibility Criteria

Inclusion Criteria

• Age between 5 and 35 years old, inclusive.
• Either a healthy volunteer or a diagnosis of a neurologically-based walking disorder due to stroke, spinal cord injury, Parkinson's disease, or cerebral palsy.
• Must be able to understand and follow simple directions based on parent report and clinical observation during the history and physical examination.
• Able to provide verbal assent, if appropriate. If the participant is non-verbal, parental interpretation of gesticulation for assent will be used.
• The ability to read and understand English.
• Able to walk at least 30 feet with or without a walking aid (GMFCS Level I-III for individuals with cerebral palsy)

Exclusion Criteria

• Any neurological, musculoskeletal or cardiorespiratory injury, health condition ( including pregnancy), or diagnosis other than stroke, spinal cord injury, Parkinson's disease or cerebral palsy that would affect the ability to walk as directed for short periods of time.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Northern Arizona University

OTHER

Sponsor Role: lead

Responsible Party

Zachary Lerner

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Northern Arizona University

Flagstaff, Arizona, United States

Countries

United States

References

Orekhov G, Fang Y, Cuddeback CF, Lerner ZF. Usability and performance validation of an ultra-lightweight and versatile untethered robotic ankle exoskeleton. J Neuroeng Rehabil. 2021 Nov 10;18(1):163. doi: 10.1186/s12984-021-00954-9.

Reference Type: DERIVED

PMID: 34758857 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1R15HD099664-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

986744

Identifier Type: -

Identifier Source: org_study_id