Trial · NCT01422161
Study of Botulinum Toxin and Recovery of Hand Function After Stroke
NCT01422161, Phase 3, Completed, NYU Langone Health; results first posted 2019-05-31
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Botulinum Toxin and Recovery of Hand Function After Stroke. Trials, record NCT01422161. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01422161
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Botulinum Toxin and Recovery of Hand Function After Stroke
- NCT number
- NCT01422161
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 16 participants, actual
- Lead sponsor
- NYU Langone Health
- Conditions
- Stroke With Hemiparesis
- Interventions
- Botulinum Toxin commonly known as BOTOX®, Placebo
- First posted
- 2011-08-23
- Last updated
- 2019-06-20
- Results first posted
- 2019-05-31
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time Taken to Form a Stable Grasp Pre-Treatment | Day 1 | Assessments are done on day 1, before the 1st Botulinum toxin injection. They will be assessed for: * Hand motor impairment (execution and planning) during a functional grasp and lift tasks. * Hand function. |
| Primary | Time Taken to Form a Stable Grasp Post Treatment | 90 Days | * Hand motor impairment (execution and planning) during a functional grasp and lift tasks. * Hand function. |
| Secondary | Measure of Upper Limb Motor Impairment Measured by Fugl Meyer Scale | Pre-Treatment, Day 90 | This scale has 3 points for each item. A zero is given for the item if the subject cannot do the task. A score of 1 is given when the task is performed partially and a score of 2 is given when the task is performed fully. Reflex activity is measured using 2 points only, with a score of 0 or 3 for absence and presence of reflex. The maximum total score that can be obtained in Fugl Meyer assessment is 226, though it is common practice to assess all domains separately.The five domains assessed by Fugl-Meyer scale are: Motor function (Maximum score in upper limb = 66; Maximum score in lower limb = 34) Sensory function (Maximum score = 24) Balance (Maximum score = 14) Range of motion of joints (Maximum score = 44) Joint pain (Maximum score = 44) |
| Secondary | Disability Measured by Modified Rankin Scale Score Post-Treatment | 90 Days | Measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.The mRS is an ordered scale coded from 0 (no symptoms at all), 1 (No significant disability despite symptoms; able to carry out all usual duties and activities), 2 (Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance), 3 (Moderate disability; requiring some help, but able to walk without assistance), 4 (Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance), 5 (severe disability) and 6 (death). |
| Secondary | Motor Impairment Measured by the Fugl-Meyer Scale Post-Treatment | 1 Day and 90 Days | Scale is comprised of five domains and there are 155 items in total: Motor functioning (in the upper and lower extremities); Sensory functioning (evaluates light touch on two surfaces of the arm and leg, and position sense for 8 joints); Balance (contains 7 tests, 3 seated and 4 standing); Joint range of motion (8 joints); Joint pain. Each domain contains multiple items, each scored on a 3-point ordinal scale (0 = cannot perform, 1= perform partially, 2 = perform fully). |
| Secondary | Disability Measured by Modified Rankin Scale Score Pre-Treatment | Pre-Treatment | Measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.The mRS is an ordered scale coded from 0 (no symptoms at all), 1 (No significant disability despite symptoms; able to carry out all usual duties and activities), 2 (Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance), 3 (Moderate disability; requiring some help, but able to walk without assistance), 4 (Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance), 5 (severe disability) and 6 (death). |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time Taken to Form a Stable Grasp Pre-Treatment | Day 1 | Improved motor execution as measured by the time taken to form a stable grasp. | Preload phase duration in Seconds | MEAN |
| PRIMARY | Time Taken to Form a Stable Grasp Post Treatment | 90 Days | Time taken to form a stable grasp. | Preload phase duration in Seconds | MEAN |
| SECONDARY | Measure of Upper Limb Motor Impairment Measured by Fugl Meyer Scale | Pre-Treatment, Day 90 | Total upper limb Fugl Meyer scale score out of 66. | Fugl Meyer Scale Score | MEAN |
| SECONDARY | Disability Measured by Modified Rankin Scale Score Post-Treatment | 90 Days | Modified Rankin Scale Score | MEAN | |
| SECONDARY | Motor Impairment Measured by the Fugl-Meyer Scale Post-Treatment | 1 Day and 90 Days | Total upper limb Fugl Meyer Score out of 66. | score on a scale | MEAN |
| SECONDARY | Disability Measured by Modified Rankin Scale Score Pre-Treatment | Pre-Treatment | Modified Rankin Scale Score | MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time Taken to Form a Stable Grasp Pre-Treatment | Control (Saline) Group -PRE Treatment | 1.51 | Standard Error .21 | Preload phase duration in Seconds | |
| Time Taken to Form a Stable Grasp Pre-Treatment | Botox Group -PRE Treatment | 1.14 | Standard Error .59 | Preload phase duration in Seconds | |
| Time Taken to Form a Stable Grasp Post Treatment | Control (Saline) Group -POST Treatment | 2.65 | Standard Error 0.17 | Preload phase duration in Seconds | |
| Time Taken to Form a Stable Grasp Post Treatment | Botox Group -POST Treatment | .79 | Standard Error .09 | Preload phase duration in Seconds | |
| Measure of Upper Limb Motor Impairment Measured by Fugl Meyer Scale | Control (Saline) Group -PRE Treatment | 47.6 | Standard Error 4 | Fugl Meyer Scale Score | |
| Measure of Upper Limb Motor Impairment Measured by Fugl Meyer Scale | Botox Group -PRE Treatment | 40.7 | Standard Error 3.31 | Fugl Meyer Scale Score | |
| Disability Measured by Modified Rankin Scale Score Post-Treatment | Control (Saline) Group -POST | 2 | Standard Deviation 0.36 | Modified Rankin Scale Score | |
| Disability Measured by Modified Rankin Scale Score Post-Treatment | Botox Group -POST | 1.8 | Standard Deviation 0.24 | Modified Rankin Scale Score | |
| Motor Impairment Measured by the Fugl-Meyer Scale Post-Treatment | Control (Saline) Group -POST Treatment | 52.1 | Standard Error 3.5 | score on a scale | |
| Motor Impairment Measured by the Fugl-Meyer Scale Post-Treatment | Botox Group -POST Treatment | 45.5 | Standard Error 2.85 | score on a scale |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Botulinum Toxin Commonly Known as BOTOX® | 10 | |
| Overall Study | STARTED | Placebo | 6 | |
| Overall Study | COMPLETED | Botulinum Toxin Commonly Known as BOTOX® | 10 | |
| Overall Study | COMPLETED | Placebo | 6 | |
| Overall Study | NOT COMPLETED | Botulinum Toxin Commonly Known as BOTOX® | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Botulinum Toxin Commonly Known as BOTOX® | 0 | 10 |
| Total, all-cause mortality | Placebo | 0 | 6 |
| Total, other adverse events | Botulinum Toxin Commonly Known as BOTOX® | 0 | 10 |
| Total, other adverse events | Placebo | 0 | 6 |
| Total, serious adverse events | Botulinum Toxin Commonly Known as BOTOX® | 0 | 10 |
| Total, serious adverse events | Placebo | 0 | 6 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Botulinum Toxin Commonly Known as BOTOX® vs Placebo: deaths from any cause | Trial comparisons |
| Botulinum Toxin Commonly Known as BOTOX® vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01422161
GET https://conductscience.org/api/trials/v1/NCT01422161/registered