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

Cerebral Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03255590
• Other study ID #: NA_00082367
• Secondary ID: 2R01HD053793-09A
• Status: Completed
• Phase: N/A
• Start date: March 3, 2017
• Est. completion date: December 30, 2020

Study information

• Verified date: November 2021
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 30, 2020
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Stroke
• Stroke

Intervention

Behavioral:
• Configuration task
Training the impaired hand on a configuration task

Locations

Country	Name	City	State
United States	Kennedy Krieger Institute	Baltimore	Maryland

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from Baseline Individuation Index at 2 weeks
Primary	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.	Change from Baseline ARAT at 2 weeks
Primary	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	Change from Baseline Impairment Index at 2 weeks
Primary	Accuracy (Euclidian norm)	The deviation of each finger from a target amount of force generation during a set of finger movements.	Change from Baseline Accuracy at 2 weeks
Secondary	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.	Change from Baseline Execution Time at 2 weeks
Secondary	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	Change from Baseline SWME at 2 weeks
Secondary	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	Change from Baseline Modified Ashworth Scale at 2 weeks