Can we Train Patients With Chronic Stroke Out of Abnormal Hand Synergy?
Primary Purpose
Cerebral Stroke
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Configuration task
Sponsored by
About this trial
This is an interventional basic science trial for Cerebral Stroke focused on measuring motor recovery, motor learning, ischemic Stroke
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- Kennedy Krieger Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Finger Dexterity Training
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
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
performs partially
performs fully
Possible score range from 0 - 66
Accuracy (Euclidian norm)
The deviation of each finger from a target amount of force generation during a set of finger movements.
Secondary Outcome Measures
Execution Time
The time period from cue appearance to the first moment when finger forces reach the required target. Lower values equal faster execution time.
Semmes Weinstein Monofilament Examination (SWME)
A quantitative method to systematically assess the threshold stimulus necessary for perception of light touch to deep pressure by using monofilaments of different sizes.
Interpretation scale for monofilaments:
2.83 Normal 3.61 Diminished light touch 4.31 Diminished protective sensation 4.56 Loss of protective sensation 6.65 Deep pressure sensation only
Modified Ashworth scale
Tests resistance to passive movement about a joint with varying degrees of velocity in order to assess muscle spasticity.
Scoring:
0 No increase in muscle tone
1 Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension.
1+ Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the Range of motion (ROM).
2 More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved.
3 Considerable increase in muscle tone, passive movement difficult.
4 Affected part(s) rigid in flexion or extension
Full Information
NCT ID
NCT03255590
First Posted
May 18, 2017
Last Updated
November 1, 2021
Sponsor
Johns Hopkins University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT03255590
Brief Title
Can we Train Patients With Chronic Stroke Out of Abnormal Hand Synergy?
Official Title
Training and Non-Invasive Brain Stimulation in Chronic Stroke Reduce Abnormal Hand Synergy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
March 3, 2017 (Actual)
Primary Completion Date
December 30, 2020 (Actual)
Study Completion Date
December 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study plans to determine whether training can change abnormal flexion synergy in chronic stroke patients.
Detailed Description
The aim of the current study is to investigate whether motor training in chronic stroke patients can change their abnormal flexion synergy. The investigators will study chronic stroke patients , who are defined as patients that sustained a stroke at least 6 months prior to our testing date.
Three functional aspects of each finger will be tested: maximal voluntary contraction (MVC), finger dexterity, and hand posture.
Prior to intervention, participants will have a baseline assessment including clinical tests, MVC, the individuation task, and the configuration task. Following the baseline assessment patients will receive intervention, training on the configuration task for 5 consecutive days. On the sixth day and as a one week follow-up after, subjects will have a post-intervention assessment containing the same tests performed in baseline.
This design will allow us to determine speed and accuracy during the configuration task, the individuation index, and possible changes in abnormal flexion synergy.
We initially registered the study as two arms (anodal tDCS and sham tDCS groups) but decided to make it one arm due to the number of participants we were able to recruit.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Stroke
Keywords
motor recovery, motor learning, ischemic Stroke
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Finger Dexterity Training
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Configuration task
Intervention Description
Training the impaired hand on a configuration task
Primary Outcome Measure Information:
Title
Individuation Index
Description
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.
Time Frame
Change from Baseline Individuation Index at 2 weeks
Title
Action Research Arm Test (ARAT)
Description
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.
Time Frame
Change from Baseline ARAT at 2 weeks
Title
Fugl-Meyer (Motor Function - Upper Extremity Subscale)
Description
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
performs partially
performs fully
Possible score range from 0 - 66
Time Frame
Change from Baseline Impairment Index at 2 weeks
Title
Accuracy (Euclidian norm)
Description
The deviation of each finger from a target amount of force generation during a set of finger movements.
Time Frame
Change from Baseline Accuracy at 2 weeks
Secondary Outcome Measure Information:
Title
Execution Time
Description
The time period from cue appearance to the first moment when finger forces reach the required target. Lower values equal faster execution time.
Time Frame
Change from Baseline Execution Time at 2 weeks
Title
Semmes Weinstein Monofilament Examination (SWME)
Description
A quantitative method to systematically assess the threshold stimulus necessary for perception of light touch to deep pressure by using monofilaments of different sizes.
Interpretation scale for monofilaments:
2.83 Normal 3.61 Diminished light touch 4.31 Diminished protective sensation 4.56 Loss of protective sensation 6.65 Deep pressure sensation only
Time Frame
Change from Baseline SWME at 2 weeks
Title
Modified Ashworth scale
Description
Tests resistance to passive movement about a joint with varying degrees of velocity in order to assess muscle spasticity.
Scoring:
0 No increase in muscle tone
1 Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension.
1+ Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the Range of motion (ROM).
2 More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved.
3 Considerable increase in muscle tone, passive movement difficult.
4 Affected part(s) rigid in flexion or extension
Time Frame
Change from Baseline Modified Ashworth Scale at 2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pablo Celnik
Organizational Affiliation
Department of Physical Medicine and Rehabilitation Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kennedy Krieger Institute
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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