Trial Outcomes & Findings for Improving Holding Function of the Hemiplegic Hand (NCT NCT02459951)
NCT ID: NCT02459951
Last Updated: 2019-07-18
Results Overview
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)
Recruitment status
COMPLETED
Target enrollment
10 participants
Primary outcome timeframe
days post-injection evaluation (mean 26 days; range 21-30 days)
Results posted on
2019-07-18
Participant Flow
Participant milestones
| Measure |
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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|---|---|
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Overall Study
STARTED
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10
|
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Overall Study
COMPLETED
|
9
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Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
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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|---|---|
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Overall Study
Unable to meet holding requirement
|
1
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Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Hemiplegic Clenched Fist
n=9 Participants
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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Age, Continuous
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61 years
n=9 Participants
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|
Sex: Female, Male
Female
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5 Participants
n=9 Participants
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Sex: Female, Male
Male
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4 Participants
n=9 Participants
|
|
Region of Enrollment
United States
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9 participants
n=9 Participants
|
|
Months post stroke
|
64 months
n=9 Participants
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|
Fugl-Meyer Assessment (upper limb motor score only)
|
24 units on a scale
n=9 Participants
|
|
Weinstein Enhanced Sensory Test (West)
|
4.42 units on a scale
n=9 Participants
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|
Visual Neglect
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0 Participants
n=9 Participants
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dominant hand is affected
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4 Participants
n=9 Participants
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days between the two baseline evaluations
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6 days
n=9 Participants
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days post injection evaluation
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26 days
n=9 Participants
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PRIMARY outcome
Timeframe: days post-injection evaluation (mean 26 days; range 21-30 days)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)
Outcome measures
| Measure |
Hemiplegic Clenched Fist
n=9 Participants
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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|---|---|
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Geometric Ratios of Log-transformed Transit Time
cylinder A (.5 " diameter)
|
1.19 dimensionless ratio
Interval 0.99 to 1.41
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Geometric Ratios of Log-transformed Transit Time
cylinder B (1" diameter)
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1.07 dimensionless ratio
Interval 0.89 to 1.27
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Geometric Ratios of Log-transformed Transit Time
cylinder C (1.5" diameter)
|
0.79 dimensionless ratio
Interval 0.65 to 0.97
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|
Geometric Ratios of Log-transformed Transit Time
cylinder D (2" diameter)
|
0.72 dimensionless ratio
Interval 0.57 to 0.9
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Geometric Ratios of Log-transformed Transit Time
cylinder E (2.5" diameter)
|
0.66 dimensionless ratio
Interval 0.51 to 0.85
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SECONDARY outcome
Timeframe: days between two baseline evaluations (mean 6; range 2-14) and days post-injection evaluation (mean 26; range 21-30)fraction of successful holds for each evaluation session (Pre1, Pre2, and Post)
Outcome measures
| Measure |
Hemiplegic Clenched Fist
n=9 Participants
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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|---|---|
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Fraction of Successful Holds for Each Evaluation Session
post injection
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.67 fraction of successful holds
Interval 0.48 to 0.95
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Fraction of Successful Holds for Each Evaluation Session
pre 1 baseline
|
.51 fraction of successful holds
Interval 0.37 to 0.72
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Fraction of Successful Holds for Each Evaluation Session
pre2 baseline
|
.53 fraction of successful holds
Interval 0.37 to 0.77
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SECONDARY outcome
Timeframe: days between two baseline evaluations (mean 6; range 2-14) and days post-injection evaluation (mean 26; range 21-30)ratio of successful holds post/pre1, post/pre2 or pre1/pre2
Outcome measures
| Measure |
Hemiplegic Clenched Fist
n=9 Participants
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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Ratio of Successful Holds
post vs. pre1
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1.31 ratio
Interval 1.05 to 1.64
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Ratio of Successful Holds
post vs pre2
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1.26 ratio
Interval 1.02 to 1.57
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Ratio of Successful Holds
pre1 vs pre2
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.96 ratio
Interval 0.71 to 1.3
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OTHER_PRE_SPECIFIED outcome
Timeframe: days between two baseline evaluations (mean 6; range 2-14) and days post-injection evaluation (mean 26; range 21-30)A clinical ordinal measure of resistance to passive stretch of a limb on a scale of 0-4 with higher scores representing greater resistance
Outcome measures
| Measure |
Hemiplegic Clenched Fist
n=9 Participants
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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|---|---|
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Modified Ashworth Score (MAS)
Pre2 vs Pre1
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0 units on a scale
Interval 0.0 to 1.5
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Modified Ashworth Score (MAS)
Post vs. Pre1
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-2 units on a scale
Interval -2.0 to -1.5
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Modified Ashworth Score (MAS)
Post vs. Pre2
|
-2 units on a scale
Interval -2.0 to -1.5
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Adverse Events
Hemiplegic Clenched Fist
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place