Clinical trial NCT03255590: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Stroke
Keywords: motor recovery
motor learning
ischemic Stroke
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2017-08-21
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Individuation Index
timeFrame: Change from Baseline Individuation Index at 2 weeks
measure: Action Research Arm Test (ARAT)
timeFrame: Change from Baseline ARAT at 2 weeks
measure: Fugl-Meyer (Motor Function - Upper Extremity Subscale)
timeFrame: Change from Baseline Impairment Index at 2 weeks
measure: Accuracy (Euclidian norm)
timeFrame: Change from Baseline Accuracy at 2 weeks
Secondary outcomes:
measure: Execution Time
timeFrame: Change from Baseline Execution Time at 2 weeks
measure: Semmes Weinstein Monofilament Examination (SWME)
timeFrame: Change from Baseline SWME at 2 weeks
measure: Modified Ashworth scale
timeFrame: Change from Baseline Modified Ashworth Scale at 2 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Kennedy Krieger Institute
state: Maryland
Study officials:
affiliation: Department of Physical Medicine and Rehabilitation Johns Hopkins University
name: Pablo Celnik
role: PRINCIPAL_INVESTIGATOR
References: