Stroke
Conditions
Keywords
Hand orthosis, Stroke
Brief summary
This study seeks to explore the efficacy of several control mechanisms for the device and the impact of a device training program on its utility as a neuroprosthetic and training tool for upper limb recovery.
Detailed description
Hand rehabilitation through occupational therapy is critical for many stroke survivors, but it is also greatly limited by insurance coverage, shortage of therapists, and logistic constraints. To address this, stroke patients need a rehabilitation method they can use on their own, without direct clinical supervision, and for activities of daily living. MyHand is a wearable and active hand orthosis consisting of a glove and forearm splint, equipped with actuators and tendons which connect to the fingers.
Interventions
DEVICEEMG Band
The MyHand orthosis provides tension to the digits to open the fingers on demand. This group will wear an EMG band to control and activate the MyHand orthosis.
DEVICEShoulder harness
The MyHand orthosis provides tension to the digits to open the fingers on demand. This group will wear a shoulder strap to control and activate the MyHand orthosis, either with shoulder elevation or shoulder depression.
Sponsors
Wallace H. Coulter Foundation
U.S. National Science Foundation
Columbia University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Subjects are assessed by an independent therapist. The therapist is not blinded to the control mechanism used during treatment.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects over 18 years of age * History of stroke resulting in significant upper limb impairment * Full passive range of motion * Gross control of the proximal upper extremity * Lacks timely grasp/release * No more than moderate flexor tone * Intact cognition
Exclusion criteria
include: * Other Neurological/orthopedic disorders * Excessive spasticity/contracture
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Score on Action Research Arm Test (ARAT) | Baseline; Post-test at Week 4 | The ARAT is a 19-item measure that assesses upper limb functioning. The ARAT is divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). Performance on each item is rated on a 4-point ordinal scale ranging from 0 (cannot perform) to 3 (normal performance). Scores on the ARAT range from 0-57 points, with higher scores indicating better performance. |
| Score on the Upper Extremity Component of the Fugl-Meyer Scale (UEFM) | Baseline; Post-test at Week 4 | The Fugl-Meyer (FM) Assessment of Motor Recovery evaluates and measures recovery in post-stroke hemiplegic patients. The FM uses a 3-point ordinal scale from 0 (cannot perform) to 2 (performs fully). The FM has 5 domains with a maximum score of 226 points. Subscales can be administered with out using the full FM. The Upper Extremity component (UEFM) consists of 33 items with a score range of 0-66. Higher score indicate better performance. Please note: An a prior decision was made to only perform the UEFM once at post-testing: post test without robotic assistance. The UEFM assesses capacity of the arm primarily through gross motor tasks, and comparatively few grasping and pinching tasks. Thus, it was presumed that robotic assistance would have minimal influence on UEFM scores. In other words, the UEFM was intended as a outcome measure to primarily evaluate the rehabilitative effects of training with the device, as opposed to evaluating the assistive capacity of using the device. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Score on Modified Ashworth Scale (MAS) | Baseline | The Ashworth or Modified Ashworth Scale (MAS) is a measure of spasticity originally developed as a simple clinical classification to assess the anti-spastic effects of carisoprodol in multiple sclerosis. It is rated on a 5-point nominal scale using subjective clinical assessments of tone ranging from 0 (no increases in tone) to 4 (limb rigid in flexion/extension or abduction/adduction). Please note: MAS is officially scored on a 5-point scale that includes 1+ (full range: 0, 1, 1+, 2, 3, 4). However non-numeric scores are not allowable in the Outcome Measure Data Table. Therefore, the scores were transformed from a 0-4 scale (including 1+) to a 0-5 scale (excluding 1+). The reported medians for all but Finger Flexors were not impacted by the scale transformation. Finger Flexor median is reported as 2 in the Outcome Measure Data Table, but this can be understood as a true median of 1+ if using the original MAS scoring scale. |
| Score on Box and Blocks Test (BBT) | Baseline; Post-test at Week 4 | The BBT measures unilateral gross manual dexterity using blocks and a 2-compartment box. At the start, there are 150 blocks in one compartment and the score represents the number of blocks transferred from one compartment to the other compartment in 60 seconds. Each hand is scored separately, however only scores for the impaired (hemiplegic) hand are reported. Scores can range from 0-150, with higher scores indicating better performance of manual dexterity. |
| Number of Participants Completing Treatment Protocol | 4 Weeks | The number of participants who completed the full treatment protocol (12 training sessions). |
| Total Number of Adverse Events During Intervention | 4 Weeks | All adverse events will be tracked during the course of the intervention. The Principal Investigator will review any event and assess it as either adverse or non-significant. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MyHand Orthosis Subjects are trained to control and use the MyHand orthosis either with a shoulder harness or an EMG band. The MyHand orthosis aims to aid in fine motor skills such as picking up and holding items of varying shape, size and weight.
EMG Band: The MyHand orthosis provides tension to the digits to open the fingers on demand. This group will wear an EMG band to control and activate the MyHand orthosis.
Shoulder harness: The MyHand orthosis provides tension to the digits to open the fingers on demand. This group will wear a shoulder strap to control and activate the MyHand orthosis, either with shoulder elevation or shoulder depression. | 11 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | MyHand Orthosis | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 3 Participants | — |
| Age, Categorical Between 18 and 65 years | 8 Participants | — |
| Age, Continuous | 52 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 11 Participants | — |
| Sex: Female, Male Female | 5 Participants | — |
| Sex: Female, Male Male | 6 Participants | — |
| Type of Stroke Hemorragic Stroke | 1 Participants | — |
| Type of Stroke Ischemic Stroke | 9 Participants | — |
| Type of Stroke Unknown Type (by participant) | 1 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 11 |
| other Total, other adverse events | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 |
Outcome results
Primary
Score on Action Research Arm Test (ARAT)
The ARAT is a 19-item measure that assesses upper limb functioning. The ARAT is divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). Performance on each item is rated on a 4-point ordinal scale ranging from 0 (cannot perform) to 3 (normal performance). Scores on the ARAT range from 0-57 points, with higher scores indicating better performance.
Time frame: Baseline; Post-test at Week 4
Population: Only the 11 subjects that completed the study were included in this analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MyHand Orthosis | Score on Action Research Arm Test (ARAT) | Baseline | 13.46 score on a scale | Standard Error 2.184 |
| MyHand Orthosis | Score on Action Research Arm Test (ARAT) | Post Unassisted (week 4) | 14.82 score on a scale | Standard Error 2.148 |
| MyHand Orthosis | Score on Action Research Arm Test (ARAT) | Post Assisted (week 4) | 13.09 score on a scale | Standard Error 1.43 |
Comparison: Baseline scores compared to Post Unassisted condition (ARAT performed unassisted/without the use of the MyHand device).p-value: 0.24t-test, 2 sided
Comparison: Post Unassisted condition (ARAT performed unassisted/without the use of the MyHand device) compared to Post Assisted condition (ARAT performed assisted with the use of the MyHand device).p-value: 0.207t-test, 2 sided
Primary
Score on the Upper Extremity Component of the Fugl-Meyer Scale (UEFM)
The Fugl-Meyer (FM) Assessment of Motor Recovery evaluates and measures recovery in post-stroke hemiplegic patients. The FM uses a 3-point ordinal scale from 0 (cannot perform) to 2 (performs fully). The FM has 5 domains with a maximum score of 226 points. Subscales can be administered with out using the full FM. The Upper Extremity component (UEFM) consists of 33 items with a score range of 0-66. Higher score indicate better performance. Please note: An a prior decision was made to only perform the UEFM once at post-testing: post test without robotic assistance. The UEFM assesses capacity of the arm primarily through gross motor tasks, and comparatively few grasping and pinching tasks. Thus, it was presumed that robotic assistance would have minimal influence on UEFM scores. In other words, the UEFM was intended as a outcome measure to primarily evaluate the rehabilitative effects of training with the device, as opposed to evaluating the assistive capacity of using the device.
Time frame: Baseline; Post-test at Week 4
Population: Only the 11 subjects that completed the study were included in this analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MyHand Orthosis | Score on the Upper Extremity Component of the Fugl-Meyer Scale (UEFM) | Baseline | 25.36 score on a scale | Standard Error 1.521 |
| MyHand Orthosis | Score on the Upper Extremity Component of the Fugl-Meyer Scale (UEFM) | Post Unassisted (week 4) | 28 score on a scale | Standard Error 1.854 |
Comparison: Baseline scores compared to Post Unassisted condition (UEMF performed unassisted/without the use of the MyHand device).p-value: 0.026Paired sample T-test
Secondary
Number of Participants Completing Treatment Protocol
The number of participants who completed the full treatment protocol (12 training sessions).
Time frame: 4 Weeks
Population: Number of participants who completed the treatment protocol (12 sessions). Only the 11 subjects that completed the study were included in this analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MyHand Orthosis | Number of Participants Completing Treatment Protocol | 11 Participants |
Secondary
Score on Box and Blocks Test (BBT)
The BBT measures unilateral gross manual dexterity using blocks and a 2-compartment box. At the start, there are 150 blocks in one compartment and the score represents the number of blocks transferred from one compartment to the other compartment in 60 seconds. Each hand is scored separately, however only scores for the impaired (hemiplegic) hand are reported. Scores can range from 0-150, with higher scores indicating better performance of manual dexterity.
Time frame: Baseline; Post-test at Week 4
Population: Only the 11 subjects that completed the study were included in this analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MyHand Orthosis | Score on Box and Blocks Test (BBT) | Baseline | 47 Blocks | Standard Error 2.289 |
| MyHand Orthosis | Score on Box and Blocks Test (BBT) | Post Unassisted (week 4) | 35 Blocks | Standard Error 1.843 |
| MyHand Orthosis | Score on Box and Blocks Test (BBT) | Post Assisted (week 4) | 24 Blocks | Standard Error 0.585 |
Comparison: Baseline scores compared to Post Unassisted condition (BBT performed unassisted/without the use of the MyHand device) of the impaired (hemiparetic) hand.p-value: 0.442Wilcoxon (Mann-Whitney)
Comparison: Post Unassisted condition (BBT performed unassisted/without the use of the MyHand device) compared to Post Assisted condition (BBT performed assisted with the use of the MyHand device).p-value: 1Wilcoxon (Mann-Whitney)
Secondary
Score on Modified Ashworth Scale (MAS)
The Ashworth or Modified Ashworth Scale (MAS) is a measure of spasticity originally developed as a simple clinical classification to assess the anti-spastic effects of carisoprodol in multiple sclerosis. It is rated on a 5-point nominal scale using subjective clinical assessments of tone ranging from 0 (no increases in tone) to 4 (limb rigid in flexion/extension or abduction/adduction). Please note: MAS is officially scored on a 5-point scale that includes 1+ (full range: 0, 1, 1+, 2, 3, 4). However non-numeric scores are not allowable in the Outcome Measure Data Table. Therefore, the scores were transformed from a 0-4 scale (including 1+) to a 0-5 scale (excluding 1+). The reported medians for all but Finger Flexors were not impacted by the scale transformation. Finger Flexor median is reported as 2 in the Outcome Measure Data Table, but this can be understood as a true median of 1+ if using the original MAS scoring scale.
Time frame: Baseline
Population: Baseline scores on MAS. Only the 11 subjects that completed the study were included in this analysis.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| MyHand Orthosis | Score on Modified Ashworth Scale (MAS) | Elbow Flexors (baseline) | 1 score on a scale |
| MyHand Orthosis | Score on Modified Ashworth Scale (MAS) | Elbow Extensors (baseline) | 1 score on a scale |
| MyHand Orthosis | Score on Modified Ashworth Scale (MAS) | Wrist Flexors (baseline) | 1 score on a scale |
| MyHand Orthosis | Score on Modified Ashworth Scale (MAS) | Wrist Extensors (baseline) | 0 score on a scale |
| MyHand Orthosis | Score on Modified Ashworth Scale (MAS) | Finger Flexors (baseline) | 2 score on a scale |
| MyHand Orthosis | Score on Modified Ashworth Scale (MAS) | Finger Extensors (baseline) | 0 score on a scale |
Secondary
Total Number of Adverse Events During Intervention
All adverse events will be tracked during the course of the intervention. The Principal Investigator will review any event and assess it as either adverse or non-significant.
Time frame: 4 Weeks
Population: Number of participants who experienced adverse events. Only the 11 subjects that completed the study were included in this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MyHand Orthosis | Total Number of Adverse Events During Intervention | 0 adverse events |