MyoSense- Automated Muscle Hypertonicity Classification System

NCT ID: NCT02076581

Last Updated: 2015-06-01

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

COMPLETED

Total Enrollment

53 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-02-28

Study Completion Date

2015-04-30

Brief Summary

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It is often difficult to quantify and distinguish aspects of abnormal muscle tone due to neurological injury. This makes it difficult to evaluate therapies that aim to reduce the effects of abnormal muscle tone. This research study will evaluate the feasibility of a clinician worn device to capture and quantify features of spasticity and dystonia.

Detailed Description

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Conditions

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Stroke Dystonia Cerebral Palsy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Stroke

Ten individuals with chronic stroke and limb spasticity will be recruited.

No interventions assigned to this group

Dystonia

Ten individuals with dystonic limbs and no spasticity will be recruited.

No interventions assigned to this group

Cerebral Palsy

Ten individuals with Cerebral palsy with the potential for a mix of dystonic and spastic abnormal tone in their affected limbs will be recruited.

No interventions assigned to this group

Neurologically normal

Thirty individuals without neurological injury that are age matched to the rest of the study population will be recruited.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Presentation of dystonia and/or spasticity or, if in control group, no neurological injury nor abnormal muscle tone
* Over the age of five.

Exclusion Criteria

* Intolerable pain with manipulation of the knee, ankle, wrist, or elbow
* Limited range of motion in the knee, ankle, wrist or elbow due to orthopedic injury or severe contraction.
* Cognitive impairment resulting in inability to provide informed consent or complete the protocol.
* Under the age of five.
Minimum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Cleveland Clinic

OTHER

Sponsor Role collaborator

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role collaborator

Great Lakes NeuroTechnologies Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joseph P Giuffrida, PhD

Role: PRINCIPAL_INVESTIGATOR

Great Lakes NeuroTechnologies Inc.

Locations

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Great Lakes NeuroTechnologies

Valley View, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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1R43NS076052-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NS076052-1

Identifier Type: -

Identifier Source: org_study_id

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