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

Training and Non-Invasive Brain Stimulation in Chronic Stroke Reduce Abnormal Hand Synergy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03255590
Enrollment
20
Registered
2017-08-21
Start date
2017-03-03
Completion date
2020-12-30
Last updated
2021-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Stroke

Keywords

motor recovery, motor learning, ischemic Stroke

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.

Interventions

BEHAVIORALConfiguration task

Training the impaired hand on a configuration task

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
Johns Hopkins University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 99 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Individuation IndexChange from Baseline Individuation Index at 2 weeksThe 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)Change from Baseline ARAT at 2 weeksAssesses 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)Change from Baseline Impairment Index at 2 weeksAssesses 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
Accuracy (Euclidian norm)Change from Baseline Accuracy at 2 weeksThe deviation of each finger from a target amount of force generation during a set of finger movements.

Secondary

MeasureTime frameDescription
Semmes Weinstein Monofilament Examination (SWME)Change from Baseline SWME at 2 weeksA 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 scaleChange from Baseline Modified Ashworth Scale at 2 weeksTests 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
Execution TimeChange from Baseline Execution Time at 2 weeksThe time period from cue appearance to the first moment when finger forces reach the required target. Lower values equal faster execution time.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026