Stroke
Conditions
Keywords
Hand Strength, Electromyography
Brief summary
Despite the functional importance, fingertip forces are rarely explicitly addressed with feedback in therapy. This gap in treatment is due to a lack of tools to provide explicit feedback on patients' volitional finger force generation. To address this unmet need, the investigators developed a novel tool for practice of volitional three-dimensional (3D) force generation with explicit feedback. The objective of this project is to determine if 3D finger force training is an effective tool in restoring hand function post stroke.
Detailed description
Despite the functional importance, fingertip forces are rarely explicitly addressed with feedback in therapy. This gap in treatment is due to a lack of tools to provide explicit feedback on patients' volitional finger force generation. To address this unmet need, the investigators developed a novel tool for practice of volitional three-dimensional (3D) force generation with explicit feedback. The objective of this project is to determine if 3D finger force training is an effective tool in restoring hand function post stroke. Stroke survivors with moderate to severe hand impairment with at least palpable volitional grip force will randomly be assigned to either the experimental or control group, stratified by impairment level. Both groups will undergo 3 1-hr training sessions per week for 6 weeks in which they practice volitional finger force generation against force sensors. The experimental group will practice for various target force directions to explore the 3D force workspace and receive feedback in 3D force, while the control group will practice 1D force generation without feedback on other directional forces on a computer screen. Training will progress by increasing influence of flexion synergy by varying posture requirements and increasing force level, introducing feedback delay, and incorporating unilateral/bilateral activity. Evaluation will occur at baseline (3 times over 3 weeks to establish baseline trends) and every 2 weeks during 6-week intervention to determine pattern of progress, and at 1-month follow-up to assess retention.
Interventions
BEHAVIORAL3D
Practice generating grip force to the target shown on the computer screen in 3 dimensions.
BEHAVIORAL1D
Practice generating grip force to the target shown on the computer screen in 1 dimension.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Survived a stroke at least 3 months ago * Moderate to severe hand impairment (Chedoke-McMaster Hand Stage 2-4) * Ability to generate palpable volitional grip force upon cue * Sufficient cognitive ability to participate (NIH Stroke Scale, NIHSS, Questions and Commands score = 0-1) * Ability to recognize all quadrants of the visual field (NIHSS Visual Field Test score = 0)
Exclusion criteria
* Concurrent upper limb rehabilitation * Inability to follow 2-step commands * Severe muscle tone prohibiting passive movement of the fingers or proper placement of the fingers on the force sensors as needed to participate in the training (Modified Ashworth Scale=4-5 out of 5) * Change in spasticity medication or botulinum toxin injection in the upper limb within 3 months prior to or during enrollment * Total sensory loss on fingertips (NIHSS Sensory score=2) * Comorbidity (e.g., orthopaedic conditions that limit ranges of motion, premorbid neurologic conditions) * Language barrier or cognitive impairment that precludes providing consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Action Research Arm Test (ARAT) | baseline to within 1 week post intervention | change in a clinical assessment, ARAT, that is in a scale 0-57 with a higher score representing better upper extremity function |
Other
| Measure | Time frame | Description |
|---|---|---|
| Box and Block Test | baseline to within 1 week post intervention | a clinical assessment measuring the number of blocks that a person can move in a minute, with a higher score representing better upper extremity function |
| Stroke Impact Scale Hand Subscale | baseline to within 1 week post intervention | Perceived difficulty in using the affected hand for activities of daily living. Scale 0-100. A higher score represents better function (less difficulty). |
| Action Research Arm Test | baseline to 1 month post intervention | change in a clinical assessment of Action Research Arm Test that is in a scale 0-57 with a higher score representing better upper extremity function |
Countries
United States
Participant flow
Pre-assignment details
Not meeting inclusion criteria (n=1) Declined to participate (n=3) Funding ended (n=2)
Participants by arm
| Arm | Count |
|---|---|
| Visual Feedback of 3D Digit Force The participant's voluntary grip forces in all 3 dimensions will be shown to the participant via computer screen.
3D: Practice generating grip force to the target shown on the computer screen in 3 dimensions. | 22 |
| Visual Feedback of 1D Digit Force The participant's voluntary grip force in 1 dimension will be shown to the participant via computer screen.
1D: Practice generating grip force to the target shown on the computer screen in 1 dimension. | 23 |
| Total | 45 |
Baseline characteristics
| Characteristic | Visual Feedback of 3D Digit Force | Visual Feedback of 1D Digit Force | Total |
|---|---|---|---|
| Age, Continuous | 59 years STANDARD_DEVIATION 12 | 60 years STANDARD_DEVIATION 9 | 59 years STANDARD_DEVIATION 10 |
| 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 | 10 Participants | 8 Participants | 18 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 | 12 Participants | 15 Participants | 27 Participants |
| Region of Enrollment United States | 22 Participants | 23 Participants | 45 Participants |
| Sex: Female, Male Female | 9 Participants | 9 Participants | 18 Participants |
| Sex: Female, Male Male | 13 Participants | 14 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 23 |
| other Total, other adverse events | 18 / 22 | 18 / 23 |
| serious Total, serious adverse events | 2 / 22 | 3 / 23 |
Outcome results
Primary
Action Research Arm Test (ARAT)
change in a clinical assessment, ARAT, that is in a scale 0-57 with a higher score representing better upper extremity function
Time frame: baseline to within 1 week post intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Visual Feedback of 3D Digit Force | Action Research Arm Test (ARAT) | 3.5 score on a scale | Standard Error 0.65 |
| Visual Feedback of 1D Digit Force | Action Research Arm Test (ARAT) | 0.8 score on a scale | Standard Error 0.66 |
Other Pre-specified
Action Research Arm Test
change in a clinical assessment of Action Research Arm Test that is in a scale 0-57 with a higher score representing better upper extremity function
Time frame: baseline to 1 month post intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Visual Feedback of 3D Digit Force | Action Research Arm Test | 3.9 score on a scale | Standard Error 0.7 |
| Visual Feedback of 1D Digit Force | Action Research Arm Test | 0.7 score on a scale | Standard Error 0.7 |
Other Pre-specified
Box and Block Test
a clinical assessment measuring the number of blocks that a person can move in a minute, with a higher score representing better upper extremity function
Time frame: baseline to within 1 week post intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Visual Feedback of 3D Digit Force | Box and Block Test | 3.03 blocks moved in 1 min | Standard Error 0.97 |
| Visual Feedback of 1D Digit Force | Box and Block Test | 0.92 blocks moved in 1 min | Standard Error 0.95 |
Other Pre-specified
Box and Block Test
a clinical assessment for upper extremity function.
Time frame: baseline to 1 month post intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Visual Feedback of 3D Digit Force | Box and Block Test | 2.5 blocks moved in 1 min | Standard Error 1 |
| Visual Feedback of 1D Digit Force | Box and Block Test | 0.5 blocks moved in 1 min | Standard Error 1 |
Other Pre-specified
Stroke Impact Scale Hand Subscale
Perceived difficulty in using the affected hand for activities of daily living. Scale 0-100. A higher score represents better function (less difficulty).
Time frame: baseline to within 1 week post intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Visual Feedback of 3D Digit Force | Stroke Impact Scale Hand Subscale | 12 score on a scale | Standard Error 2 |
| Visual Feedback of 1D Digit Force | Stroke Impact Scale Hand Subscale | 6 score on a scale | Standard Error 2 |
Other Pre-specified
Stroke Impact Scale Hand Subscale
Perceived difficulty in using the affected hand for activities of daily living. Scale 0-100. A higher score represents better function (less difficulty).
Time frame: baseline to 1 month post intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Visual Feedback of 3D Digit Force | Stroke Impact Scale Hand Subscale | 15 score on a scale | Standard Error 2 |
| Visual Feedback of 1D Digit Force | Stroke Impact Scale Hand Subscale | 8 score on a scale | Standard Error 2 |