Evaluating Wearable Robotic Assistance on Gait

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

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04119063

Enrollment

Registered

2019-10-08

Start date

2019-09-08

Completion date

2022-11-20

Last updated

2024-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Palsy

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).

Interventions

DEVICEpowered orthosis

Novel powered leg brace to provide assistance during walking.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DEVICE_FEASIBILITY

Masking

NONE

Intervention model description

Feasibility assessment of powered orthosis assistance and resistance during walking. All participants received high frequency gait training followed by a washout period then low frequency gait training.

Eligibility

Sex/Gender

ALL

Age

5 Years to 35 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
The Metabolic Energy Required to Walk	Measured at the pre (day 1) and post (day 4) gait training assessments	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.
Change in Walking Speed	Measured at the pre (day 1) and post (day 4) gait training assessments	The change in the walking speed will be measured over-ground using a stop watch. Units: % change between post vs pre assessments

Secondary

Measure	Time frame	Description
Change in Stride Length	Measured at the pre (day 1) and post (day 4) gait training assessments	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.
Change in Cadence	Measured at the pre (day 1) and post (day 4) gait training assessments	The change in the number of steps taken per minute will be measured using a counter. Units: % change between post vs pre assessments.
Change in Muscle Activity Variance Ratio	Measured at the pre (day 1) and post (day 4) gait training assessments	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.

Countries

United States

Participant flow

Pre-assignment details

All participants first completed higher frequency gait training followed by a washout period and then lower frequency gait training.

Participants by arm

Arm	Count
Exoskeleton Assistance Gait training with exoskeleton assistance at higher and lower frequencies. powered orthosis: Novel powered leg brace to provide assistance during walking.	6
Total	6

Baseline characteristics

Characteristic	Exoskeleton Assistance
Age, Categorical <=18 years	4 Participants
Age, Categorical >=65 years	0 Participants
Age, Categorical Between 18 and 65 years	2 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants
Race (NIH/OMB) Asian	0 Participants
Race (NIH/OMB) Black or African American	0 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) White	5 Participants
Region of Enrollment United States	6 participants
Sex: Female, Male Female	1 Participants
Sex: Female, Male Male	5 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 6	0 / 6
other Total, other adverse events	0 / 6	0 / 6
serious Total, serious adverse events	0 / 6	0 / 6

Outcome results

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