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This pilot study will aim to understand the potential benefit of the assessment of walking using video slow motion for muscle selection and the development of an image catalogue guide of the potential results of injection of abobotulinumtoxinA by comparing foot postures before and after injection. The objective is to evaluate the use of video assessment to improve muscle selection for the injection of botulinum toxin A to improve walking outcomes. Primary outcomes include: self-selected velocity (SSV), maximal velocity (MV) and symmetry of walking. Secondary outcomes include: passive range of motion (PROM), Modified Ashworth Scale (MAS) and the Tardieu Scale (TS). Fifteen persons post stroke or TBI over age 18 with equinovarus foot deformity who are able to ambulate will be included in the study. Dysport 1000 to 1500 units will be used to be distributed on the basis of clinical indication to ankle plantar flexors (gastrocnemius and soleus), tibialis posterior and long toe flexors. The duration of subjects' participation is 4-6 weeks.
This is a prospective, single arm, non-randomized clinical study with pre-post assessment to include post-stroke and Traumatic Brain Injury (TBI) outpatients with spastic ankle / foot muscles amenable to botulinum toxin injection. Subjects must be able to walk without braces.
AbobotulinumtoxinA injection in a dose range of 500 to 1500 units one time to be distributed on the basis of clinical indication to ankle plantar flexors (gastrocnemius and soleus), knee extensors, knee flexors, tibialis posterior and long toe flexors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dysport | Experimental | Subjects will receive 1000 to 1500 units of Dysport to be distributed on the basis of clinical indication to ankle plantar flexors (gastrocnemius and soleus), knee extensors and flexors, tibialis posterior and long toe flexors for one injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dysport | Drug | Dysport 1000 to 1500 units to be distributed on the basis of clinical indication to ankle plantar flexors (gastrocnemius and soleus), knee extensors and flexors, tibialis posterior and long toe flexors. |
| Measure | Description | Time Frame |
|---|---|---|
| Self-Selected Velocity (SSV) | Baseline and follow-up SSV with and without shoes. Distance covers over time at self selected pace. Larger value is better. | Baseline, Follow-up (4-6 weeks) |
| Maximal Velocity | Baseline and follow-up MV with and without shoes. Distance covers over time when walking as fast as possible. Larger value is better. | Baseline, Follow-up (4-6 weeks) |
| Step-length at Baseline and at Follow-up (Temporal-spatial Data) | Step length measured as the distance between the heel contact point of one foot and that of the other foot. Values are reported on the involved side. Larger values represent better outcome. | Baseline, Follow-up (4-6 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Ashworth Scale (MAS) at Baseline and at Follow-up | Passive range of ankle in 1 second with knee flexed and knee extended. Scale of 0-4 (0: no increase in muscle tone; 1: Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension; 1+:Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM (range of movement); 2: More marked increase in muscle tone through most of the ROM, but affect part(s) easily moved; 3: Considerable increase in muscle tone passive, movement difficult; 4: Affected part(s) rigid in flexion or extension. 0-4 (Min-Max) Higher scores represents increase abnormal tone. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alberto Esquenazi, MD | MossRehab | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MossRehab | Elkins Park | Pennsylvania | 19002 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dysport | All Participants |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Post-stroke and TBI outpatients with spastic ankle / foot muscles amenable to botulinum toxin injection.
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| ID | Title | Description |
|---|---|---|
| BG000 | Dysport | All Participants |
| 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 | Self-Selected Velocity (SSV) | Baseline and follow-up SSV with and without shoes. Distance covers over time at self selected pace. Larger value is better. | Posted | Mean | Standard Deviation | m/s | Baseline, Follow-up (4-6 weeks) |
|
|
Adverse event was collected at follow-up (4-6 weeks) after the baseline visit.
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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 | Dysport | Participants that received Dysport. | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stella Lee | MossRehab | 215-663-6665 | 6665 | leest@einstein.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Mar 28, 2019 | Dec 31, 2019 | ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 7, 2018 | Dec 31, 2019 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D003025 | Clubfoot |
| ID | Term |
|---|---|
| D000070558 | Talipes |
| D005531 | Foot Deformities, Acquired |
| D005530 | Foot Deformities |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| C542869 | abobotulinumtoxinA |
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|
| Baseline, Follow-up (4-6 weeks) |
| Tardieu Scale (TS) at Baseline and at Follow-up | Measurement of spastic response when passively ranging the ankle joint at very slow and very fast velocities with knee flexed and knee extended. Quality of muscle reaction (scored 0-4). 0 is no resistance to passive ROM to 4 indicating joint is immobile. | Baseline, Follow-up (4-6 weeks) |
| Passive Range of Motion (PROM) at Baseline and at Follow-up | Normal ranges of ankle dorsiflexion 0 to 30 degrees with knee flexed. Normal ranges of dorsiflexion 0 to 15 degrees with knee extended. Higher values in dorsiflexion range represent a better outcome. | Baseline, Follow-up (4-6 weeks) |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Diagnosis | Count of Participants | Participants |
|
| Paretic Side | Count of Participants | Participants |
|
| Participants |
|
|
| Primary | Maximal Velocity | Baseline and follow-up MV with and without shoes. Distance covers over time when walking as fast as possible. Larger value is better. | Posted | Mean | Standard Deviation | m/s | Baseline, Follow-up (4-6 weeks) |
|
|
|
| Primary | Step-length at Baseline and at Follow-up (Temporal-spatial Data) | Step length measured as the distance between the heel contact point of one foot and that of the other foot. Values are reported on the involved side. Larger values represent better outcome. | Posted | Mean | Standard Deviation | meters | Baseline, Follow-up (4-6 weeks) |
|
|
|
| Secondary | Modified Ashworth Scale (MAS) at Baseline and at Follow-up | Passive range of ankle in 1 second with knee flexed and knee extended. Scale of 0-4 (0: no increase in muscle tone; 1: Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension; 1+:Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM (range of movement); 2: More marked increase in muscle tone through most of the ROM, but affect part(s) easily moved; 3: Considerable increase in muscle tone passive, movement difficult; 4: Affected part(s) rigid in flexion or extension. 0-4 (Min-Max) Higher scores represents increase abnormal tone. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline, Follow-up (4-6 weeks) |
|
|
|
| Secondary | Tardieu Scale (TS) at Baseline and at Follow-up | Measurement of spastic response when passively ranging the ankle joint at very slow and very fast velocities with knee flexed and knee extended. Quality of muscle reaction (scored 0-4). 0 is no resistance to passive ROM to 4 indicating joint is immobile. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline, Follow-up (4-6 weeks) |
|
|
|
| Secondary | Passive Range of Motion (PROM) at Baseline and at Follow-up | Normal ranges of ankle dorsiflexion 0 to 30 degrees with knee flexed. Normal ranges of dorsiflexion 0 to 15 degrees with knee extended. Higher values in dorsiflexion range represent a better outcome. | Clinician moved the ankle at flexion or extension with no effort from the participant. | Posted | Mean | Standard Deviation | degrees | Baseline, Follow-up (4-6 weeks) |
|
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| 11 |
| 0 |
| 11 |
| 1 |
| 11 |
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| D005532 |
| Foot Deformities, Congenital |
| D038061 | Lower Extremity Deformities, Congenital |
| D017880 | Limb Deformities, Congenital |
| D009139 | Musculoskeletal Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |