Stroke
Conditions
Keywords
hand function
Brief summary
The objective of this pilot project is to assess the impact of the novel sensory stimulation technique the investigators have developed in enhancing outcomes of hand therapy as well as the central nervous system responsiveness in chronic stroke survivors.
Detailed description
Stroke survivors suffer from persistent hand impairment that diminishes their functional abilities and independence, despite multiple courses of rehabilitation. Sensory stimulation can prime central excitability to increase therapy outcome. The investigators developed a new sensory stimulation technique for the hand, using imperceptible vibration applied to the wrist skin. Wearable devices with a vibrating function are low cost and can be easily adopted for rehabilitation purposes to impact a wide range of patients with sensorimotor impairment. Despite the potential for clinical benefits and easy adoption for high impact, knowledge about the long-term efficacy of this new sensory stimulation technique and its underlying mechanism is limited. The objective of this pilot project is to assess the impact of the novel sensory stimulation technique the investigators have developed in enhancing outcomes of 2-week hand therapy as well as the central nervous system responsiveness in chronic stroke survivors. This impact will be assessed in a double-blind stratified randomized controlled trial. The hypothesis is that (a) improvement in hand function will be greater for the experimental group receiving the wrist subthreshold vibrotactile stimulation during therapy compared with the control group who will wear the device with no vibration (placebo). (b) Improvement in hand function is associated with neurophysiologic measures of central nervous system responsiveness. Clinical and neurophysiologic evaluations will be performed before, immediately after, and 2 weeks after a 2 week standardized hand therapy program with the subthreshold vibrotactile stimulation to the wrist vs. sham. The investigators preliminary studies demonstrated an acute effect of the remote subthreshold vibrotactile stimulation on immediately improved clinical sensory and motor function of the hand as well as cortical excitability in healthy young adults and chronic stroke survivors in single-session studies. The expected outcome is the demonstration that the subthreshold vibrotactile stimulation at the wrist enhances hand function, not only immediately (preliminary studies) but also as a complement to therapy in chronic stroke survivors. This project will also provide preliminary insights regarding plasticity occurring with hand therapy augmented by the subthreshold vibrotactile stimulation. This research will have a positive impact by leading to a portable sensorimotor orthosis worn at the wrist to improve hand function for patients with sensorimotor deficits.
Interventions
OTHERVibration
peripheral vibration at the wrist skin at an imperceptible level
No peripheral vibration at the wrist skin
BEHAVIORALtherapy
standardized hand therapy program
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
21 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* mild to moderate impairment in upper extremity function
Exclusion criteria
* cognitive dysfunction * stroke\<3 months * treatment with botulinum toxin in the affected arm within 3 months of start of study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Box and Block Test (BBT) About a Week After the 2-week Intervention | post intervention (about a week after the 2-week therapy, or week 3) compared to baseline (before 2-week therapy) | Change in hand motor function as measured by the Box and Block Test. This test measures the number of blocks that a participant moved in a minute. The scale ranges from 0 to a positive number. Higher numbers represent better outcomes. |
| Box and Block Test (BBT) at Least 2 Weeks After the 2-week Intervention | follow up (at least 2 weeks after the 2-week therapy, or week 5) compared to baseline (before 2-week therapy) | Change in hand motor function as measured by the Box and Block Test. This test measures the number of blocks that a participant moved in a minute. The scale ranges from 0 to a positive number. Higher numbers represent better outcomes. |
| WMFT About a Week After the 2-week Intervention | post intervention (about a week after the 2-week therapy, or week 3) compared to baseline (before 2-week therapy) | change in hand motor function as measured by the Wolf Motor Function Test hand items time. This test measures time to complete movements in seconds. More negative values represent greater reduction in time and thus better outcomes. |
| WMFT at Least 2 Weeks After the 2-week Intervention | follow up (2 weeks after the 2-week therapy, or week 5) compared to baseline (before 2-week therapy) | change in hand motor function as measured by the Wolf Motor Function Test hand items time. This test measures time to complete movements in seconds. More negative values represent greater reduction in time and thus better outcomes. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Experimental The experimental group receives the wrist subthreshold vibrotactile stimulation during therapy.
Vibration: peripheral vibration at the wrist skin at an imperceptible level
therapy: standardized hand therapy program | 6 |
| Placebo The control group will wear the vibration device with no vibration.
* Both groups cannot feel the vibration since the vibration intensity is set below the perceptible level.
* The vibration device is a generic, commercially-available, vibrator, not particularly used for this peripheral skin stimulation purpose.
Placebo (for vibration): No peripheral vibration at the wrist skin
therapy: standardized hand therapy program | 6 |
| Total | 12 |
Baseline characteristics
| Characteristic | Experimental | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 61 years STANDARD_DEVIATION 10 | 64 years STANDARD_DEVIATION 8 | 63 years STANDARD_DEVIATION 9 |
| baseline hand motor function (Box and Block Test score) | 29 blocks STANDARD_DEVIATION 15 | 28 blocks STANDARD_DEVIATION 11 | 29 blocks STANDARD_DEVIATION 12 |
| 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 | 1 Participants | 0 Participants | 1 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 | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 6 Participants | 11 Participants |
| Region of Enrollment United States | 6 participants | 6 participants | 12 participants |
| Sex: Female, Male Female | 1 Participants | 4 Participants | 5 Participants |
| Sex: Female, Male Male | 5 Participants | 2 Participants | 7 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 | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 |
Outcome results
Primary
Box and Block Test (BBT) About a Week After the 2-week Intervention
Change in hand motor function as measured by the Box and Block Test. This test measures the number of blocks that a participant moved in a minute. The scale ranges from 0 to a positive number. Higher numbers represent better outcomes.
Time frame: post intervention (about a week after the 2-week therapy, or week 3) compared to baseline (before 2-week therapy)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental (Therapy + Stimulation) | Box and Block Test (BBT) About a Week After the 2-week Intervention | 6 change in # of blocks | Standard Error 0.8 |
| Placebo (Therapy + Stimulation Placebo) | Box and Block Test (BBT) About a Week After the 2-week Intervention | -2 change in # of blocks | Standard Error 0.7 |
Primary
Box and Block Test (BBT) at Least 2 Weeks After the 2-week Intervention
Change in hand motor function as measured by the Box and Block Test. This test measures the number of blocks that a participant moved in a minute. The scale ranges from 0 to a positive number. Higher numbers represent better outcomes.
Time frame: follow up (at least 2 weeks after the 2-week therapy, or week 5) compared to baseline (before 2-week therapy)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental (Therapy + Stimulation) | Box and Block Test (BBT) at Least 2 Weeks After the 2-week Intervention | 4 change in # of blocks | Standard Error 0.8 |
| Placebo (Therapy + Stimulation Placebo) | Box and Block Test (BBT) at Least 2 Weeks After the 2-week Intervention | 0.5 change in # of blocks | Standard Error 0.8 |
Primary
WMFT About a Week After the 2-week Intervention
change in hand motor function as measured by the Wolf Motor Function Test hand items time. This test measures time to complete movements in seconds. More negative values represent greater reduction in time and thus better outcomes.
Time frame: post intervention (about a week after the 2-week therapy, or week 3) compared to baseline (before 2-week therapy)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental (Therapy + Stimulation) | WMFT About a Week After the 2-week Intervention | -0.19 change in ln(sec) | Standard Error 0.07 |
| Placebo (Therapy + Stimulation Placebo) | WMFT About a Week After the 2-week Intervention | 0.00 change in ln(sec) | Standard Error 0.07 |
Primary
WMFT at Least 2 Weeks After the 2-week Intervention
change in hand motor function as measured by the Wolf Motor Function Test hand items time. This test measures time to complete movements in seconds. More negative values represent greater reduction in time and thus better outcomes.
Time frame: follow up (2 weeks after the 2-week therapy, or week 5) compared to baseline (before 2-week therapy)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental (Therapy + Stimulation) | WMFT at Least 2 Weeks After the 2-week Intervention | -0.090 change in ln(sec) | Standard Error 0.074 |
| Placebo (Therapy + Stimulation Placebo) | WMFT at Least 2 Weeks After the 2-week Intervention | -0.089 change in ln(sec) | Standard Error 0.074 |