Can we Train Patients With Chronic Stroke Out of Abnormal Hand Synergy?

NCT03255590 | Completed DMC

• 2 other identifiers: NA_000823672R01HD053793-09A1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study plans to determine whether training can change abnormal flexion synergy in chronic stroke patients.

Conditions

Cerebral Stroke

Keywords

motor recovery; motor learning; ischemic Stroke

Outcome Measures

Primary Outcomes (4)

• Individuation Index

  The relationship between forces (in Newton) in active vs passive fingers during a set of isolated finger movements. It is a measure of finger independence.

  Change from Baseline Individuation Index at 2 weeks

• Action Research Arm Test (ARAT)

  Assesses upper limb functioning in activities of daily living using observational methods. It is a 19 item measure divided into a 4-point ordinal scale ranging from: 3: Performs test normally 2: Completes test, but takes abnormally long or has great difficulty 1: Performs test partially 0: Can perform no part of test. Possible score range of 0 to 57; higher scores equal less impairment.

  Change from Baseline ARAT at 2 weeks

• Fugl-Meyer (Motor Function - Upper Extremity Subscale)

  Assesses functional mobility using observational methods. It is a 66 item measure. Its items are scored on a 3-point ordinal scale. 0: Cannot perform 1. performs partially 2. performs fully Possible score range from 0 - 66

  Change from Baseline Impairment Index at 2 weeks

• Accuracy (Euclidian norm)

  The deviation of each finger from a target amount of force generation during a set of finger movements.

  Change from Baseline Accuracy at 2 weeks

Secondary Outcomes (3)

• Execution Time

  Change from Baseline Execution Time at 2 weeks

• Semmes Weinstein Monofilament Examination (SWME)

  Change from Baseline SWME at 2 weeks

• Modified Ashworth scale

  Change from Baseline Modified Ashworth Scale at 2 weeks

Study Arms (1)

Finger Dexterity Training

EXPERIMENTAL

Chronic stroke patients (i.e. great than 6 months) with ischemic stroke confirmed by CT or MRI, residual unilateral upper extremity weakness, able to give informed consent, and able to understand the tasks involved. Participants trained for 5 consecutive days, 3 to 4 h/d, on a multi-finger piano-chord-like task that cannot be performed by compensatory actions of other body parts (e.g., arm). Participants had to learn to simultaneously coordinate and synchronize multiple fingers to break unwanted flexor synergies.

Behavioral: Configuration task

Interventions

Configuration task BEHAVIORAL

Training the impaired hand on a configuration task

Finger Dexterity Training

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 21 and older
• Ischemic stroke greater than six months ago, confirmed by CT or MRI
• Residuals unilateral upper extremity weakness
• Ability to give informed consent and understand the tasks involved.
• Appearance of Flexion synergy in hand.
• Ability to extent finger at least for 5 degrees.

You may not qualify if:

• Cognitive impairment, with score on Montreal Cognitive assessment (MoCA) ≤ 20
• History of physical or neurological condition that interferes with study procedures or assessment of motor function (e.g. severe arthritis, severe neuropathy, Parkinson's disease)
• Contraindication to tDCS (deep brain stimulators or other metal in the head, skull defect, pacemaker)
• Inability to sit in a chair and perform upper limb exercises for one hour at a time
• Participation in another upper extremity rehabilitative therapy study or tDCS study during the study period
• Terminal illness
• Social and/or personal circumstances that interfere with ability to return for therapy sessions and follow up assessments
• Pregnancy
• Severe Neglect

Sponsors & Collaborators

• Johns Hopkins University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Kennedy Krieger Institute

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Stroke; Ischemic Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Pablo Celnik

  Department of Physical Medicine and Rehabilitation Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2017
• First Posted: August 21, 2017
• Study Start: March 3, 2017
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2020
• Last Updated: November 8, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)