MyoSense- Automated Muscle Hypertonicity Classification System

NCT02076581 | Completed

• 2 other identifiers: NS076052-11R43NS076052-01A1
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke; Dystonia; Cerebral Palsy

Outcome Measures

Primary Outcomes (1)

• Correlation between clinician and device measured abnormal tone type.

  Device measurements of clinician applied force relative to limb manipulation speed will be compared to conventional clinical outcome measures. For example, correlation between the slope of the force to speed profile and clinician evaluated spasticity, Ashworth score, will be calculated.

  For each subject clinician and device data will be collected within a single session. Each session will occur over a maximum of two hours. Analysis of all of the subject data will be completed within 30 days of study completion.

Study Arms (4)

Stroke

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

Dystonia

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

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.

Neurologically normal

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

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Sixty individuals, including individuals with and without abnormal muscle tone will be recruited for this study.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Great Lakes NeuroTechnologies Inc.: lead
• The Cleveland Clinic: collaborator
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Great Lakes NeuroTechnologies

Valley View, Ohio, 44125, United States

Location

MeSH Terms

Conditions

Stroke; Dystonia; Cerebral Palsy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Damage, Chronic

Study Officials

• Joseph P Giuffrida, PhD

  Great Lakes NeuroTechnologies Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2014
• First Posted: March 3, 2014
• Study Start: February 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: June 1, 2015

Record last verified: 2015-05

Locations

US (1)