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| Name | Class |
|---|---|
| Allergan | INDUSTRY |
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Relevant to patients with spastic hemiparesis in the hand and upper limb, this pilot project proposes to measure the effects of botulinum toxin injections through observation of performance on a functional task known as 'hand as a holder'. This task requires the person with hemiplegia to insert an object into the affected hand and hold it independently.
The project aims to demonstrate reliability and validity of a digital video method that will be used to measure 'insertion time'. It also aims to establish initial statistical support for improved object insertion time into the hemiplegic clenched fist after Botox A injections.
Holding is an everyday hand function, objects entering the hand radially, frontally, ulnarly or in-between the finger spaces. After a stroke, the hand of a person with hemiplegia typically lacks voluntary finger extension that opens the hand. Simultaneously, the hand is also subjected to involuntary contraction of finger flexor muscles that close the hand, resulting in clenched fist and thumb-in-palm deformities. Despite these typical hemiplegic configurations, persons with stroke may be able to insert an object into the hand by wiggling and pushing it into the hemiplegic hand with their uninvolved hand, though struggle is often present and failure is frequent. In the hemiplegic patient, a common driver of clenched fist and thumb-in-palm configurations is excessive involuntary neural activation of finger and thumb flexors, compounded by impaired or absent voluntary finger extension. Excessive finger and thumb flexor contractions have been variously ascribed to involuntary phenomena such as spasticity, spastic dystonia, co-contraction, associated reactions and others. For the investigators purpose here, these involuntary phenomena generate contractile tension in hand and thumb muscles that choke the hand's potential to function as a holder of objects as described above.
The underlying rationale of this project is to examine whether hemiplegic 'hand as a holder' function can be improved by weakening involuntary muscle contractions that generate clenched fist and thumb in palm using the neuromuscular blocking properties of Botox A. The investigators hypothesize that 'hand as a holder' function will improve after chemodenervation of relevant finger, thumb and wrist muscles selected by clinical examination.
Nine subjects will be enrolled. Baseline observations will be made on two occasions prior to Botox A injection and outcomes measured four weeks later. A digital video method will be used to measure 'insertion time' at all-time points. Given the importance of the relationship between "statistically significant" research results and "clinically significant", person-oriented, functional improvement, the investigators also hypothesize that experienced clinicians will independently rate the performance of object insertion into the clenched fist as globally better after chemodenervation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| clenched fist | Adult participants with upper limb hemiparesis secondary to stroke and greater than 12 months duration. Medical determination that .botulinum toxin injections are indicated for treatment of spasticity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| clenched fist | Other | Observation of performance on a standardized behavioral task pre- and post- administration of Botox A in the context of routine care. Clinical assessment and judgment will be used to determine dosing and which muscles contribute to the hand deformities of a given participant. |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Ratios of Log-transformed Transit Time | Time (log-transformed) required for contralateral hand to insert a plastic cylinder successfully into the hemiplegic clenched fist AND assessed at Pre-injection baseline 2 and a Post-injection session expressed as a geometric mean ratio of these sessions. (Success is defined by a hold of 5 secs or more). Geometric mean ratios are calculated for each of 5 cylinder sizes (A-E) | days post-injection evaluation (mean 26 days; range 21-30 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Fraction of Successful Holds for Each Evaluation Session | fraction of successful holds for each evaluation session (Pre1, Pre2, and Post) | days between two baseline evaluations (mean 6; range 2-14) and days post-injection evaluation (mean 26; range 21-30) |
| Ratio of Successful Holds |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Ashworth Score (MAS) | A clinical ordinal measure of resistance to passive stretch of a limb on a scale of 0-4 with higher scores representing greater resistance | days between two baseline evaluations (mean 6; range 2-14) and days post-injection evaluation (mean 26; range 21-30) |
Inclusion Criteria:
Exclusion Criteria:
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patients who are clinically appropriate for Botox A injection to treat upper limb spasticity due to stroke
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| Name | Affiliation | Role |
|---|---|---|
| Nathaniel Mayer, MD | Albert Einstein Healthcare Network | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34173778 | Derived | Mayer NH, Ferraro M, Pauloski-Hunt D, Chervoneva I. Capacity for Hand-as-a-Holder Function of the Spastic Combination Hand: A Proof-of-Concept Study. Am J Phys Med Rehabil. 2022 Mar 1;101(3):298-302. doi: 10.1097/PHM.0000000000001834. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Hemiplegic Clenched Fist | Adult participants with upper limb hemiparesis secondary to stroke and greater than 12 months duration. Medical determination that .botulinum toxin injections are indicated for treatment of spasticity. clenched fist: Observation of performance on a standardized behavioral task pre- and post- administration of Botox A in the context of routine care. Clinical assessment and judgment will be used to determine dosing and which muscles contribute to the hand deformities of a given participant. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Hemiplegic Clenched Fist | Adult participants with upper limb hemiparesis secondary to stroke and greater than 12 months duration. Medical determination that .botulinum toxin injections are indicated for treatment of spasticity. clenched fist: Observation of performance on a standardized behavioral task pre- and post- administration of Botox A in the context of routine care. Clinical assessment and judgment will be used to determine dosing and which muscles contribute to the hand deformities of a given participant. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Geometric Ratios of Log-transformed Transit Time | Time (log-transformed) required for contralateral hand to insert a plastic cylinder successfully into the hemiplegic clenched fist AND assessed at Pre-injection baseline 2 and a Post-injection session expressed as a geometric mean ratio of these sessions. (Success is defined by a hold of 5 secs or more). Geometric mean ratios are calculated for each of 5 cylinder sizes (A-E) | Posted | Geometric Mean | 95% Confidence Interval | dimensionless ratio | days post-injection evaluation (mean 26 days; range 21-30 days) |
|
until 5 weeks post injection
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hemiplegic Clenched Fist | Adult participants with upper limb hemiparesis secondary to stroke and greater than 12 months duration. Medical determination that .botulinum toxin injections are indicated for treatment of spasticity. clenched fist: Observation of performance on a standardized behavioral task pre- and post- administration of Botox A in the context of routine care. Clinical assessment and judgment will be used to determine dosing and which muscles contribute to the hand deformities of a given participant. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nathaniel Mayer MD | Albert Einstein Healthcare Network | 215 663 6681 | nmayer@einstein.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 29, 2016 | Dec 31, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D009128 | Muscle Spasticity |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
ratio of successful holds post/pre1, post/pre2 or pre1/pre2 |
| days between two baseline evaluations (mean 6; range 2-14) and days post-injection evaluation (mean 26; range 21-30) |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Months post stroke | Mean | Full Range | months |
|
| Fugl-Meyer Assessment (upper limb motor score only) | Scale range is 0 to 66 (upper extremity motor score only); higher score is better | Mean | Full Range | units on a scale |
|
| Weinstein Enhanced Sensory Test (West) | scale measures sensation using monofilament pressure; scale range is: 1.65 -6.65; lower score is better | Mean | Full Range | units on a scale |
|
| Visual Neglect | The presence of visual neglect as determined by clinical examination | Count of Participants | Participants |
|
| dominant hand is affected | Count of Participants | Participants |
|
| days between the two baseline evaluations | Mean | Full Range | days |
|
| days post injection evaluation | number of days after participants were injected with OnabotulinumtoxinA and then evaluated | Mean | Full Range | days |
|
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|
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| Secondary | Fraction of Successful Holds for Each Evaluation Session | fraction of successful holds for each evaluation session (Pre1, Pre2, and Post) | Posted | Mean | 95% Confidence Interval | fraction of successful holds | days between two baseline evaluations (mean 6; range 2-14) and days post-injection evaluation (mean 26; range 21-30) |
|
|
|
| Secondary | Ratio of Successful Holds | ratio of successful holds post/pre1, post/pre2 or pre1/pre2 | Posted | Mean | 95% Confidence Interval | ratio | days between two baseline evaluations (mean 6; range 2-14) and days post-injection evaluation (mean 26; range 21-30) |
|
|
|
| Other Pre-specified | Modified Ashworth Score (MAS) | A clinical ordinal measure of resistance to passive stretch of a limb on a scale of 0-4 with higher scores representing greater resistance | Posted | Median | 95% Confidence Interval | units on a scale | days between two baseline evaluations (mean 6; range 2-14) and days post-injection evaluation (mean 26; range 21-30) |
|
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| 0 |
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| Title | Measurements |
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