Direction Modulation of Muscle Synergies After a Stroke

NCT03063151 | Unknown

• 1 other identifier: UH022017
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to investigate the capacity of post-stroke individual (study group) to modulate their EMG muscle activation pattern (MAP) compared to healthy individuals (control group), and to correlate these capacities with their motor impairments. Twenty post-stroke individuals and 12 healthy individuals will participate in this study. each participant will carry out hand-reaching movements in multiple directions, monitored by an EMG device. The modulation of the EMG signal will be compared between groups in terms of EMG-MAP and in terms of muscle-synergies. Additionally the MAPs and synergies of the study group will be correlated with their Fugl-Meyer (FM) assessment scores. Analysis of the muscle synergies underlying the EMG signal will be carried out by the Non-negative Matrix Factorization (NMF) algorithm.

Conditions

Stroke; Motor Disorders

Outcome Measures

Primary Outcomes (1)

• Optimal number of synergies

  The NMF will be applied, changing the number of synergies from 2-7. The highest VAF value for each participant will define the number of synergies for this participant.

  Between one week to one month after a stroke (study group).

Secondary Outcomes (3)

• Muscle Activation Pattern (MAP)

  Between one week to one month after a stroke (study group).

• Similarity Index- Individual (SI-I)

  Between one week to one month after a stroke (study group).

• Similarity Index- Direction (SI-D)

  Between one week to one month after a stroke (study group).

Study Arms (2)

Study Group

EXPERIMENTAL

The Maximum isometric Voluntary Contraction (MVC) was measured by standard muscle testing. Then the subject sat in front of a table with his forearm resting in a comfortable position. The Hand Reaching Spatial Device (HRSD) was located at the maximal hand-reaching range of motion. Participants were requested to point on each target 5 times according to voice prompting that was activated by the EMG software every 10 seconds, for 45 pointing movements. The order of pointing targets was constant for all the participants.

Diagnostic Test: Surface Electromyography (EMG)

Control Group

EXPERIMENTAL

The Maximum isometric Voluntary Contraction (MVC) was measured by standard muscle testing. Then the subject sat in front of a table with his forearm resting in a comfortable position. The Hand Reaching Spatial Device (HRSD) was located at the maximal hand-reaching range of motion. Participants were requested to point on each target 5 times according to voice prompting that was activated by the EMG software every 10 seconds, for 45 pointing movements. The order of pointing targets was constant for all the participants.

Diagnostic Test: Surface Electromyography (EMG)

Interventions

Surface Electromyography (EMG) DIAGNOSTIC_TEST

Control Group; Study Group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cortical stroke (study group)
• hemiparesis

You may not qualify if:

• sensory aphasia
• complete arm paralysis
• unilateral neglect
• other neurological disease (PD, Alzheimer)

Sponsors & Collaborators

• University of Haifa: lead

Study Sites (1)

Bait Balev Medical Center

Nesher, Israel

RECRUITING

MeSH Terms

Conditions

Stroke; Motor Disorders

Interventions

Electromyography

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Electrodiagnosis; Diagnostic Techniques and Procedures; Diagnosis; Myography

Central Study Contacts

Sharon Israely, M.Sc.

CONTACT

972-523-755091; sharonis@mh.org.il

Eli Carmeli, Ph.D.

CONTACT

972-507-393454; ecarmeli@univ.haifa.ac.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two groups of participants: Study and control. Each participant will carry out a single one-hour session of EMG test.

Study Record Dates

• First Submitted: February 21, 2017
• First Posted: February 24, 2017
• Study Start: February 14, 2016
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: October 27, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)