StrokeNCT03473808
Functional Connectivity & Stimulation-enhanced Therapy Post Stroke
A study testing task-practice therapy and Vibration in people with Stroke, run by Medical University of South Carolina at 1 site in United States.
Trial summary
After stroke, it is common for individuals to experience hand impairment. This deficit can severely restrict functional ability and independence. Recovery of hand function following stroke is highly variable. In this study, the investigators will use brain imaging to predict individual response to treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- task-practice therapy and Vibration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Mar 2018to 24 Sep 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age = 18 or older
- At least 6 months post-stroke
- Moderate upper limb impairment with the ability to participate in hand task practices
- Fingertip touch sensory deficits (e.g., Monofilament>2.83, 2-point discrimination>5mm, sense of numbness, tingling)
Who cannot join
- Complete upper limb deafferentation
- Rigidity (Modified Ashworth Scale=5)
- Botulinum toxin injection within 3 months prior to enrollment or during enrollment
- Brainstem stroke
- Comorbidity (peripheral neuropathy, orthopaedic conditions in the hand that limit ranges of motion, premorbid neurologic conditions, compromised skin integrity of the hand/wrist due to long-term use of blood thinners)
- Concurrent upper extremity rehabilitation therapy
- Language barrier or cognitive impairment that precludes following instructions or providing consent
- MRI incompatible.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29403
About this study
Official title: Brain Functional Connectivity & Sensory Stimulation-enhanced Therapy Post Stroke
After stroke, it is common for individuals to experience hand impairment. This deficit can severely restrict functional ability and independence. Recovery of hand function following stroke is highly variable. In this study, the investigators will use brain imaging to predict individual response to treatment. Survivors of stroke will receive upper extremity therapy while they concurrently receive imperceptible vibration to the wrist aimed to enhance therapy outcomes.
Read the detailed description
The ability to predict individuals' responses to treatment can enable effective allocation of a treatment to likely responders. The long-term goal is to determine whether acute changes in brain functional connectivity immediately after one treatment session can predict ultimate gains in motor function after completing multiple treatment sessions. The objective of this study is to determine feasibility and to examine association between change in brain functional connectivity after one session and motor gains after completion of all treatment sessions. This study is a prospective single-cohort longitudinal study. The treatment is task-practice therapy (3d/wk, 18-session) accompanied with concurrent imperceptible wrist vibration that is intended to prime the cortical sensorimotor network and enhance hand functional recovery in chronic stroke survivors. Hand function will be assessed before/after therapy and at 1-month follow-up. Connectivity will be assessed using fMRI and EEG before and after a treatment session.
- Conditions
- Stroke
- Being tested
- task-practice therapy, Vibration
- Keywords
- Hand Function, Occupational Therapy, Physical Stimulation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
task-practice therapyBehavioural
Standardized hand therapy program
VibrationOther
Peripheral vibration applied to the wrist skin at an imperceptible level
| Study group | Role | What they receive |
|---|---|---|
| therapy + vibration | Experimental | Imperceptible vibration applied to the wrist during a standardized hand task practice therapy program. Receives: Behavioral: task-practice therapy; Other: Vibration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Hand Motor Function
Change in hand motor function as measured by the Box and Block Test. The test measures the number of blocks that a participant moves within one minute. The scale ranges from 0 to a positive number. Higher numbers represent better outcomes.
Measured: Baseline to approximately 1 week after the completion of 18 therapy sessions.
Mean Change in Hand Motor Function
Change in hand motor function as measured by the Box and Block Test. The test measures the number of blocks that a participant moves within one minute. The scale ranges from 0 to a positive number. Higher numbers represent better outcomes.
Measured: Baseline to approximately 4 weeks after the completion of 18 therapy sessions.
Secondary outcomes (2)
Mean Change in Hand Motor Function
Change in hand motor function as measured by the Wolf Motor Function Test Time. This test measures time to complete upper extremity movements in seconds. More negative values represent a greater reduction in time, thus better outcomes.
Measured: Baseline to approximately 1 week after the completion of 18 therapy sessions.
Mean Change in Hand Motor Function
Change in hand motor function as measured by the Wolf Motor Function Test Time. This test measures time to complete upper extremity movements in seconds. More negative values represent a greater reduction in time, thus better outcomes.
Measured: Baseline to approximately 4 weeks after the completion of 18 therapy sessions.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2018
- Study start7 Mar 2018
- Primary completion24 Sep 2018
- Study completion24 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS), University of Delaware
- Responsible party
- Principal investigator, Na Jin Seo, Medical University of South Carolina
- Investigators
- Steve Kautz, PhD, Study chair, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03473808
- Sponsor's protocol ID
- PRO74041
- Other IDs
- U54GM104941
- Status last verified
- Mar 2019
- First submitted
- 5 Mar 2018
- Last updated
- 5 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- 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 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Functional Connectivity & Sensory Stimulation-enhanced Therapy Post Stroke
- ClinicalTrials.gov ID
- NCT03473808
- Acronym / sponsor ID
- PRO74041
- Conditions
- Stroke
- Keywords
- Hand Function, Occupational Therapy, Physical Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS), University of Delaware
- Study start
- 7 Mar 2018 (actual)
- Primary completion
- 24 Sep 2018 (actual)
- Study completion
- 24 Sep 2018 (actual)
- First posted
- 22 Mar 2018 (actual)
- Results
- Posted 5 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
After stroke, it is common for individuals to experience hand impairment. This deficit can severely restrict functional ability and independence. Recovery of hand function following stroke is highly variable. In this study, the investigators will use brain imaging to predict individual response to treatment. Survivors of stroke will receive upper extremity therapy while they concurrently receive imperceptible vibration to the wrist aimed to enhance therapy outcomes.
Detailed description
The ability to predict individuals' responses to treatment can enable effective allocation of a treatment to likely responders. The long-term goal is to determine whether acute changes in brain functional connectivity immediately after one treatment session can predict ultimate gains in motor function after completing multiple treatment sessions. The objective of this study is to determine feasibility and to examine association between change in brain functional connectivity after one session and motor gains after completion of all treatment sessions. This study is a prospective single-cohort longitudinal study. The treatment is task-practice therapy (3d/wk, 18-session) accompanied with concurrent imperceptible wrist vibration that is intended to prime the cortical sensorimotor network and enhance hand functional recovery in chronic stroke survivors. Hand function will be assessed before/after therapy and at 1-month follow-up. Connectivity will be assessed using fMRI and EEG before and after a treatment session.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| therapy + vibration | Experimental | Behavioral: task-practice therapy, Other: VibrationImperceptible vibration applied to the wrist during a standardized hand task practice therapy program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age = 18 or older
- At least 6 months post-stroke
- Moderate upper limb impairment with the ability to participate in hand task practices
- Fingertip touch sensory deficits (e.g., Monofilament>2.83, 2-point discrimination>5mm, sense of numbness, tingling)
Key exclusion criteria (8 listed)
- Complete upper limb deafferentation
- Rigidity (Modified Ashworth Scale=5)
- Botulinum toxin injection within 3 months prior to enrollment or during enrollment
- Brainstem stroke
- Comorbidity (peripheral neuropathy, orthopaedic conditions in the hand that limit ranges of motion, premorbid neurologic conditions, compromised skin integrity of the hand/wrist due to long-term use of blood thinners)
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 |
|---|---|---|
| task-practice therapyStandardized hand therapy program | Behavioural | therapy + vibration |
| VibrationPeripheral vibration applied to the wrist skin at an imperceptible level | Other | therapy + vibration |
Primary outcome
Mean Change in Hand Motor Function
Time frame: Baseline to approximately 1 week after the completion of 18 therapy sessions.
Change in hand motor function as measured by the Box and Block Test. The test measures the number of blocks that a participant moves within one minute. The scale ranges from 0 to a positive number. Higher numbers represent better outcomes.
Mean Change in Hand Motor Function
Time frame: Baseline to approximately 4 weeks after the completion of 18 therapy sessions.
Change in hand motor function as measured by the Box and Block Test. The test measures the number of blocks that a participant moves within one minute. The scale ranges from 0 to a positive number. Higher numbers represent better outcomes.
2 secondary outcomes
Mean Change in Hand Motor Function
Time frame: Baseline to approximately 1 week after the completion of 18 therapy sessions.
Mean Change in Hand Motor Function
Time frame: Baseline to approximately 4 weeks after the completion of 18 therapy sessions.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Steve Kautz, PhD study chair
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing task-practice therapy and Vibration in people with Stroke, run by Medical University of South Carolina 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 4 inclusion and 8 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 5 Mar 2019. 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?
Yes. Results are posted in the registry (first posted 5 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Change in Hand Motor Function (time frame: Baseline to approximately 1 week after the completion of 18 therapy sessions.). The study lists 2 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 5 Mar 2019.