Evaluating Wearable Robotic Assistance on Gait

Cerebral Palsy Clinical Trial

Official title:

Evaluating Wearable Robotic Assistance on Gait Mechanics and Energetics in Individuals With Neurological Impairment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04119063
• Other study ID #: 986744
• Secondary ID: 1R15HD099664-01
• Status: Completed
• Phase: Early Phase 1
• Start date: September 8, 2019
• Est. completion date: November 20, 2022

Study information

• Verified date: January 2024
• Source: Northern Arizona University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: November 20, 2022
• Est. primary completion date: November 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Device:
• powered orthosis
Novel powered leg brace to provide assistance during walking.

Locations

Country	Name	City	State
United States	Northern Arizona University	Flagstaff	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Northern Arizona University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Metabolic Energy Required to Walk	The change in the metabolic energy required to walk will be measured using a portable metabolic measurement system (Cosmed K5). Units: change in % difference post vs pre gait training.	Measured at the pre (day 1) and post (day 4) gait training assessments
Primary	Change in Walking Speed	The change in the walking speed will be measured over-ground using a stop watch. Units: % change between post vs pre assessments	Measured at the pre (day 1) and post (day 4) gait training assessments
Secondary	Change in Stride Length	The change in the stride length will be measured by dividing the number of steps by distance traveled. Units: % change between post vs pre assessments.	Measured at the pre (day 1) and post (day 4) gait training assessments
Secondary	Change in Cadence	The change in the number of steps taken per minute will be measured using a counter. Units: % change between post vs pre assessments.	Measured at the pre (day 1) and post (day 4) gait training assessments
Secondary	Change in Muscle Activity Variance Ratio	The change in the muscle activity variance ratio of the soleus during walking will be measured using electromyography electrodes. Units: % change between post vs pre assessments.	Measured at the pre (day 1) and post (day 4) gait training assessments