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Completed

NCT Number: NCT03255590

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

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

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Key information

Conditions

Cerebral Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

21 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kennedy Krieger Institute

Baltimore, Maryland, 21205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Configuration task

Behavioral

Training the impaired hand on a configuration task

Primary outcomes

  1. 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.

  2. 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.

  3. 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

    • performs partially
    • performs fully

    Possible score range from 0 - 66

  4. 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.

Secondary outcomes

  1. Execution Time

    Time frame: Change from Baseline Execution Time at 2 weeks

    The time period from cue appearance to the first moment when finger forces reach the required target. Lower values equal faster execution time.

  2. Semmes Weinstein Monofilament Examination (SWME)

    Time frame: Change from Baseline SWME at 2 weeks

    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

  3. Modified Ashworth scale

    Time frame: Change from Baseline Modified Ashworth Scale at 2 weeks

    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

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Aug 21, 2017
Registry last updated
Nov 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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