Ankle Exosuit Training in the Clinic to Community Community

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-10

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Stroke

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Previous work has demonstrated that the tuning of the exosuit technology is important for each patient post stroke to be able to maximally utilize the technology. These modulations include when the plantarflexion force is delivered, and how to deliver the assistance within a training session however it is still unclear how to implement this into a training protocol. During a part of 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 a training protocol

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ReWalk Soft Exosuit

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.

Group Type EXPERIMENTAL

Treadmill walking

Intervention Type OTHER

Up to 5 bouts of 6 minutes walking on the treadmill with rest breaks allowed between sets

Overground Walking

Intervention Type OTHER

Up to 5 bouts of 6 minutes walking overground with rest breaks allowed between sets

Interventions

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Treadmill walking

Up to 5 bouts of 6 minutes walking on the treadmill with rest breaks allowed between sets

Intervention Type OTHER

Overground Walking

Up to 5 bouts of 6 minutes walking overground with rest breaks allowed between sets

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No