Ankle Exosuit Training in the Clinic to Community Community

Arun Jayaraman, PT, PhD

Status: Active, not recruiting

Conditions: Stroke

Treatments: Other: Overground Walking; Other: Treadmill walking

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT04251091

STU00209869

Details and patient eligibility

About

This study focuses on investigating exosuit technology by evaluating its ability to provide a gait-restorative effect delivered in both clinic and community settings. The exosuit provides dynamic dorsiflexion and plantarflexion assist during walking. We will determine the effect of training parameters of intensity, repetition, and gait quality which are all key parameters associated with experience-dependent neuroplasticity. The other objective is to determine the effect of this intervention on community walking activity, walking speed, walking distance, and locomotor mechanics and energetics.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 - 80 years old
• Stroke event occurred at least 6 months ago
• Observable gait deficits
• Able to walk without the support of another person for at least 2 minutes (with or without an assistive device or orthotic support)
• Passive ankle dorsiflexion range of motion to neutral with the knee extended (i.e., able to achieve an angle of 90 degrees between the shank and the foot)
• Resting heart rate between 40 - 100 bpm, inclusive
• Resting blood pressure between 90/60 and 170/90 mmHg, inclusive
• Medical clearance by a physician

Exclusion criteria

• Score of >1 on question 1b and >0 on question 1c on the NIH Stroke Scale
• Inability to communicate with investigators
• Neglect or hemianopia
• Unexplained dizziness in the last 6 months
• Pressure ulcers or skin wounds located at human-device interface sites
• History of significant Peripheral Artery Disease (PAD)
• Unresolved Deep Vein Thrombosis (DVT)
• Uncontrolled or untreated hypertension
• Significant paretic ankle contractures (plantarflexion > 5°)
• Psychiatric or cognitive impairments that may interfere with proper operation of the device

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

ReWalk Soft Exosuit

Experimental group

Description:

During this study, we will explore which timing: early timing (10-20%), mid timing (50%) and late timing (90%) may be optimal for an individual and then carry out an 18 session training protocol.

Treatment:

Other: Overground Walking

Other: Treadmill walking