Cerebral StrokeNCT03255590
Can we Train Patients With Chronic Stroke Out of Abnormal Hand Synergy?
A study testing Configuration task in people with Cerebral Stroke, run by Johns Hopkins University at 1 site in United States.
Trial summary
This study plans to determine whether training can change abnormal flexion synergy in chronic stroke patients. Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Cerebral Stroke
- What is being tested?
- Configuration task
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2017to 30 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- Social and/or personal circumstances that interfere with ability to return for therapy sessions and follow up assessments
- Pregnancy
- Severe Neglect
Trial locations and contacts
1 site in 1 country.
United States1 site
Kennedy Krieger Institute
Baltimore, Maryland, 21205
About this study
Official title: Training and Non-Invasive Brain Stimulation in Chronic Stroke Reduce Abnormal Hand Synergy
This study plans to determine whether training can change abnormal flexion synergy in chronic stroke patients.
Read the 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.
- Conditions
- Cerebral Stroke
- Being tested
- Configuration task
- Keywords
- motor recovery, motor learning, ischemic Stroke
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Configuration taskBehavioural
Training the impaired hand on a configuration task
| Study group | Role | What they receive |
|---|---|---|
| Finger Dexterity Training | Experimental | 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. Receives: Behavioral: Configuration task |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline Individuation Index at 2 weeks
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.
Measured: Change from Baseline ARAT at 2 weeks
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
Measured: Change from Baseline Impairment Index at 2 weeks
Accuracy (Euclidian norm)
The deviation of each finger from a target amount of force generation during a set of finger movements.
Measured: Change from Baseline Accuracy at 2 weeks
Secondary outcomes (3)
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.
Measured: Change from Baseline Execution Time at 2 weeks
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
Measured: Change from Baseline SWME at 2 weeks
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
Measured: Change from Baseline Modified Ashworth Scale at 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2017
- Study start3 Mar 2017
- Primary completion30 Dec 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral StrokeStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Pablo Celnik, Principal investigator, Department of Physical Medicine and Rehabilitation Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03255590
- Sponsor's protocol ID
- NA_00082367
- Other IDs
- 2R01HD053793-09A1
- Status last verified
- Nov 2021
- First submitted
- 18 May 2017
- Last updated
- 8 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Training and Non-Invasive Brain Stimulation in Chronic Stroke Reduce Abnormal Hand Synergy
- ClinicalTrials.gov ID
- NCT03255590
- Acronym / sponsor ID
- NA_00082367
- Conditions
- Cerebral Stroke
- Keywords
- motor recovery, motor learning, ischemic Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 3 Mar 2017 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 21 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Finger Dexterity Training | Experimental | Behavioral: Configuration taskChronic 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. |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Configuration taskTraining the impaired hand on a configuration task | Behavioural | Finger Dexterity Training |
Primary outcome
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.
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.
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
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.
3 secondary outcomes
Execution Time
Time frame: Change from Baseline Execution Time at 2 weeks
Semmes Weinstein Monofilament Examination (SWME)
Time frame: Change from Baseline SWME at 2 weeks
Modified Ashworth scale
Time frame: Change from Baseline Modified Ashworth Scale at 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2021.
- Individual participant dataSharing planned: No
Related trials for Cerebral Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pablo Celnik principal investigator
Department of Physical Medicine and Rehabilitation Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Configuration task in people with Cerebral Stroke, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Individuation Index (time frame: Change from Baseline Individuation Index at 2 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2021.