Functional Connectivity & Stimulation-enhanced Therapy Post Stroke
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
task-practice therapy
Vibration
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Hand Function, Occupational Therapy, Physical Stimulation
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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.
Sites / Locations
- Medical University of South Carolina
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
therapy + vibration
Arm Description
Imperceptible vibration applied to the wrist during a standardized hand task practice therapy program.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT03473808
First Posted
March 5, 2018
Last Updated
March 1, 2019
Sponsor
Medical University of South Carolina
Collaborators
National Institute of General Medical Sciences (NIGMS), University of Delaware
1. Study Identification
Unique Protocol Identification Number
NCT03473808
Brief Title
Functional Connectivity & Stimulation-enhanced Therapy Post Stroke
Official Title
Brain Functional Connectivity & Sensory Stimulation-enhanced Therapy Post Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
March 7, 2018 (Actual)
Primary Completion Date
September 24, 2018 (Actual)
Study Completion Date
September 24, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
Collaborators
National Institute of General Medical Sciences (NIGMS), University of Delaware
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Hand Function, Occupational Therapy, Physical Stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
therapy + vibration
Arm Type
Experimental
Arm Description
Imperceptible vibration applied to the wrist during a standardized hand task practice therapy program.
Intervention Type
Behavioral
Intervention Name(s)
task-practice therapy
Intervention Description
Standardized hand therapy program
Intervention Type
Other
Intervention Name(s)
Vibration
Intervention Description
Peripheral vibration applied to the wrist skin at an imperceptible level
Primary Outcome Measure Information:
Title
Mean Change in Hand Motor Function
Description
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.
Time Frame
Baseline to approximately 1 week after the completion of 18 therapy sessions.
Title
Mean Change in Hand Motor Function
Description
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.
Time Frame
Baseline to approximately 4 weeks after the completion of 18 therapy sessions.
Secondary Outcome Measure Information:
Title
Mean Change in Hand Motor Function
Description
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.
Time Frame
Baseline to approximately 1 week after the completion of 18 therapy sessions.
Title
Mean Change in Hand Motor Function
Description
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.
Time Frame
Baseline to approximately 4 weeks after the completion of 18 therapy sessions.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steve Kautz, PhD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Study Chair
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29403
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Functional Connectivity & Stimulation-enhanced Therapy Post Stroke
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