Stroke
Conditions
Keywords
Hand Function, Occupational Therapy, Physical Stimulation
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.
Interventions
BEHAVIORALtask-practice therapy
Standardized hand therapy program
OTHERVibration
Peripheral vibration applied to the wrist skin at an imperceptible level
Sponsors
National Institute of General Medical Sciences (NIGMS)
University of Delaware
Medical University of South Carolina
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Hand Motor Function | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Hand Motor Function | Baseline to approximately 1 week after the completion of 18 therapy sessions. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Therapy + Vibration Imperceptible vibration applied to the wrist during a standardized hand task practice therapy program.
Task-Practice Therapy: Standardized hand therapy program
Vibration: Peripheral vibration applied to the wrist skin at an imperceptible level | 5 |
| Total | 5 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Therapy + Vibration |
|---|---|
| Age, Continuous | 70 years STANDARD_DEVIATION 5.18 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 5 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 5 |
| other Total, other adverse events | 4 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
Primary
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.
Time frame: Baseline to approximately 1 week after the completion of 18 therapy sessions.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Therapy + Vibration | Mean Change in Hand Motor Function | 0.83 blocks | Standard Deviation 3.09 |
Primary
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.
Time frame: Baseline to approximately 4 weeks after the completion of 18 therapy sessions.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Therapy + Vibration | Mean Change in Hand Motor Function | 0.21 blocks | Standard Deviation 1.18 |
Secondary
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.
Time frame: Baseline to approximately 1 week after the completion of 18 therapy sessions.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Therapy + Vibration | Mean Change in Hand Motor Function | -10.09 seconds | Standard Deviation 3.66 |
Secondary
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.
Time frame: Baseline to approximately 4 weeks after the completion of 18 therapy sessions.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Therapy + Vibration | Mean Change in Hand Motor Function | -14.24 seconds | Standard Deviation 5.51 |