Training and Non-Invasive Brain Stimulation in Chronic Stroke Reduce Abnormal Hand Synergy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Johns Hopkins University
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Fugl-Meyer (Motor Function - Upper Extremity Subscale)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Finger Dexterity Training
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: Configuration task (Behavioral)
Outcomes
Primary Outcomes
Fugl-Meyer (Motor Function - Upper Extremity Subscale)
Time Frame: Change from Baseline Impairment Index at 2 weeks
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
Action Research Arm Test (ARAT)
Time Frame: Change from Baseline ARAT at 2 weeks
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.
Accuracy (Euclidian norm)
Time Frame: Change from Baseline Accuracy at 2 weeks
The deviation of each finger from a target amount of force generation during a set of finger movements.
Individuation Index
Time Frame: Change from Baseline Individuation Index at 2 weeks
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.
Secondary Outcomes
- Execution Time(Change from Baseline Execution Time at 2 weeks)
- Modified Ashworth scale(Change from Baseline Modified Ashworth Scale at 2 weeks)
- Semmes Weinstein Monofilament Examination (SWME)(Change from Baseline SWME at 2 weeks)