Physical Disability, Stroke
Conditions
Keywords
physical stimulation, Subliminal stimulation, stroke rehabilitation, upper extremity, paresis, hand function, occupational therapy, physical therapy
Brief summary
More than 4 million stroke survivors in the U.S. suffer from post-stroke sensorimotor hand disability, which is typically permanent and difficult to treat. Hand disability has a profound negative impact on functional ability and independence. One way to improve hand function is to use peripheral sensory stimulation. Sensory stimulation in conjunction with therapy has been shown to improve motor outcomes more than therapy alone. While promising, most modalities of sensory stimulation interfere with natural hand tasks. To address these practical limitations, we have developed a new stimulation, imperceptible random-frequency vibration applied to wrist skin via a watch. In this study, we will determine if use of this vibration increases hand functional recovery.
Detailed description
The study design is a double-blinded randomized controlled study. Subjects will wear the device for at least 8 hours/day every day for a month, during which they will come to the laboratory for weekly evaluation. Follow-up evaluation will occur 3 months after. The device will deliver vibration (treatment) or no vibration (control).
Interventions
OTHERperipheral vibration stimulation
wearing a wristband that delivers imperceptible vibratory stimulation.
BEHAVIORALtherapy
practice of daily living tasks
Sponsors
National Institute of General Medical Sciences (NIGMS)
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Chronic stroke survivor (\>= 6 months post stroke) * Ability to move an object with the paretic hand * Fingertip sensory deficits * Ability to put on a watch daily (by oneself or with help)
Exclusion criteria
* Currently undergoing other upper extremity rehabilitation therapy * Upper limb botulinum toxin within 3 months prior to or during enrollment * Change in neurological disorder medications during the enrollment * Complete upper limb deafferentation * Rigidity (Modified Ashworth Scale=5) * 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) * Language barrier or cognitive impairment that precludes following instructions and/or providing consent If a participant has contraindications for Transcranial Magnetic Stimulation (TMS), the participant will not do TMS.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Short-latency Afferent Inhibition | 1 month | motor evoked potential suppression by conditioning electrical stimulation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Action Research Arm Test | 1 month | standardized clinical upper extremity function score |
Other
| Measure | Time frame | Description |
|---|---|---|
| Timing of Reactive Force Generation Per Perturbation | 1 month | time of reactive force |
| Fugl-Meyer Upper Limb Assessment | 1 month | standardized clinical upper extremity function score |
| Grip Force Direction | 1 month | angle of the grip force vector from the normal direction |
| In-home Hand Use Amount | 1 month | affected hand use amount as measured by accelerometers |
| Reactive Force Magnitude Per Perturbation | 1 month | magnitude of reactive grip force |
| Safety Margin | 1 month | additional force used during grip |
| Stroke Impact Scale Hand Subscale | 1 month | standardized patient-reported hand function assessment |
| Spectral Power Perturbation During Grip | 1 month | EEG spectral power perturbation during grip |
| Connectivity | 1 month | EEG coherence within the sensorimotor network |
| Short-latency Afferent Inhibition | 4 month | motor evoked potential suppression by conditioning electrical stimulation |
| Box and Block Test | 1 month | number of blocks moved in a minute |
| Wolf Motor Function Test | 1 month | standardized clinical upper extremity function score |
| Action Research Arm Test | 4 month | standardized clinical upper extremity function score |
| Corticomotor Excitability | 1 month | motor evoked potential amplitude |
| Stoke Impact Scale Hand Subscale | 4 month | standardized patient-reported hand function assessment |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Stimulation + Therapy The participant receives stimulation and home therapy.
peripheral vibration stimulation: wearing a wristband that delivers imperceptible vibratory stimulation.
therapy: practice of daily living tasks | 6 |
| no Stimulation + Therapy The participant receives no stimulation and receives home therapy.
therapy: practice of daily living tasks | 6 |
| Total | 12 |
Baseline characteristics
| Characteristic | Stimulation + Therapy | Total | no Stimulation + Therapy |
|---|---|---|---|
| Age, Continuous | 60 years STANDARD_DEVIATION 12 | 61 years STANDARD_DEVIATION 10 | 61 years STANDARD_DEVIATION 9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 6 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 3 Participants | 5 Participants | 2 Participants |
| Region of Enrollment United States | 6 participants | 12 participants | 6 participants |
| Sex: Female, Male Female | 2 Participants | 6 Participants | 4 Participants |
| Sex: Female, Male Male | 4 Participants | 6 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 0 / 6 | 1 / 6 |
| serious Total, serious adverse events | 0 / 6 | 1 / 6 |
Outcome results
Primary
Short-latency Afferent Inhibition
motor evoked potential suppression by conditioning electrical stimulation
Time frame: 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stimulation + Therapy | Short-latency Afferent Inhibition | 48 % of unconditioned motor evoked potentia | Standard Deviation 56 |
| no Stimulation + Therapy | Short-latency Afferent Inhibition | 21 % of unconditioned motor evoked potentia | Standard Deviation 35 |
Secondary
Action Research Arm Test
standardized clinical upper extremity function score
Time frame: 1 month
Other Pre-specified
Action Research Arm Test
standardized clinical upper extremity function score
Time frame: 4 month
Other Pre-specified
Box and Block Test
number of blocks moved in a minute
Time frame: 4 month
Other Pre-specified
Box and Block Test
number of blocks moved in a minute
Time frame: 1 month
Other Pre-specified
Connectivity
EEG coherence within the sensorimotor network
Time frame: 4 month
Other Pre-specified
Connectivity
EEG coherence within the sensorimotor network
Time frame: 1 month
Other Pre-specified
Corticomotor Excitability
motor evoked potential amplitude
Time frame: 4 month
Other Pre-specified
Corticomotor Excitability
motor evoked potential amplitude
Time frame: 1 month
Other Pre-specified
Fugl-Meyer Upper Limb Assessment
standardized clinical upper extremity function score
Time frame: 4 month
Other Pre-specified
Fugl-Meyer Upper Limb Assessment
standardized clinical upper extremity function score
Time frame: 1 month
Other Pre-specified
Grip Force Direction
angle of the grip force vector from the normal direction
Time frame: 4 month
Other Pre-specified
Grip Force Direction
angle of the grip force vector from the normal direction
Time frame: 1 month
Other Pre-specified
In-home Hand Use Amount
affected hand use amount as measured by accelerometers
Time frame: 1 month
Other Pre-specified
In-home Hand Use Amount
affected hand use amount as measured by accelerometers
Time frame: 4 month
Other Pre-specified
Reactive Force Magnitude Per Perturbation
magnitude of reactive grip force
Time frame: 1 month
Other Pre-specified
Reactive Force Magnitude Per Perturbation
magnitude of reactive grip force
Time frame: 4 month
Other Pre-specified
Safety Margin
additional force used during grip
Time frame: 4 month
Other Pre-specified
Safety Margin
additional force used during grip
Time frame: 1 month
Other Pre-specified
Short-latency Afferent Inhibition
motor evoked potential suppression by conditioning electrical stimulation
Time frame: 4 month
Other Pre-specified
Spectral Power Perturbation During Grip
EEG spectral power perturbation during grip
Time frame: 1 month
Other Pre-specified
Spectral Power Perturbation During Grip
EEG spectral power perturbation during grip
Time frame: 4 month
Other Pre-specified
Stoke Impact Scale Hand Subscale
standardized patient-reported hand function assessment
Time frame: 4 month
Other Pre-specified
Stroke Impact Scale Hand Subscale
standardized patient-reported hand function assessment
Time frame: 1 month
Other Pre-specified
Timing of Reactive Force Generation Per Perturbation
time of reactive force
Time frame: 4 month
Other Pre-specified
Timing of Reactive Force Generation Per Perturbation
time of reactive force
Time frame: 1 month
Other Pre-specified
Wolf Motor Function Test
standardized clinical upper extremity function score
Time frame: 1 month
Other Pre-specified
Wolf Motor Function Test
standardized clinical upper extremity function score
Time frame: 4 month