Equinovarus; AcquiredPhase 4NCT03501043
Assessment of Gait After Dysport Treatment
A Phase 4 study testing Dysport in people with Equinovarus; Acquired, run by Albert Einstein Healthcare Network at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Equinovarus; Acquired
- What is being tested?
- Dysport
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jun 2018to 22 Aug 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide signed and dated informed consent form
- Willing to comply with all study procedures and be available for the duration of the study
- Male or female, aged ≥ 18
- Equinovarus foot deformity appropriate for botulinum toxin treatment (naïve or non-naïve)
- Modified Ashworth Scale between 1 to 3
- Women of reproductive potential must use effective contraception for the duration of the study
Who cannot join
- Inability to walk without leg brace
- Previous surgical intervention to affected/ankle/foot
- Uncontrolled seizures
- Pregnancy or lactation
- Known allergic reactions to Dysport
- Treatment with another investigational drug or other intervention in the past 4 months
Show all 10Show fewer
- Modified Ashworth Scale 4
- Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study
- Lower motor neuron disorder
- < Four months post botulinum toxin or serial casting
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Video and Temporal Spatial Parameters Assessment of Gait After Dysport Treatment. A Pilot Study
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.
Read the detailed description
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.
- Conditions
- Equinovarus; Acquired
- Being tested
- Dysport
- Medical subject headings
- Clubfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DysportDrug
Also called abobotulinumtoxinA
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Dysport |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline, Follow-up (4-6 weeks)
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Baseline, Follow-up (4-6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start11 Jun 2018
- Primary completion22 Aug 2019
- Study completion22 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Equinovarus; AcquiredStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein Healthcare Network
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alberto Esquenazi, Albert Einstein Healthcare Network
- Investigators
- Alberto Esquenazi, MD, Principal investigator, MossRehab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03501043
- Sponsor's protocol ID
- 5075
- Status last verified
- Feb 2020
- First submitted
- 4 Apr 2018
- Last updated
- 2 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video and Temporal Spatial Parameters Assessment of Gait After Dysport Treatment. A Pilot Study
- ClinicalTrials.gov ID
- NCT03501043
- Acronym / sponsor ID
- 5075
- Conditions
- Equinovarus; Acquired
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Albert Einstein Healthcare NetworkUniversity, hospital or other
- Study start
- 11 Jun 2018 (actual)
- Primary completion
- 22 Aug 2019 (actual)
- Study completion
- 22 Aug 2019 (actual)
- First posted
- 18 Apr 2018 (actual)
- Results
- Posted 2 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dysport | Experimental | Drug: DysportSubjects 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Provide signed and dated informed consent form
- Willing to comply with all study procedures and be available for the duration of the study
- Male or female, aged ≥ 18
- Equinovarus foot deformity appropriate for botulinum toxin treatment (naïve or non-naïve)
- Modified Ashworth Scale between 1 to 3
Key exclusion criteria (10 listed)
- Inability to walk without leg brace
- Previous surgical intervention to affected/ankle/foot
- Uncontrolled seizures
- Pregnancy or lactation
- Known allergic reactions to Dysport
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DysportAlso: abobotulinumtoxinADysport 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. | Drug | Dysport |
Primary outcome
Self-Selected Velocity (SSV)
Time frame: Baseline, Follow-up (4-6 weeks)
Baseline and follow-up SSV with and without shoes. Distance covers over time at self selected pace. Larger value is better.
Maximal Velocity
Time frame: Baseline, Follow-up (4-6 weeks)
Baseline and follow-up MV with and without shoes. Distance covers over time when walking as fast as possible. Larger value is better.
Step-length at Baseline and at Follow-up (Temporal-spatial Data)
Time frame: Baseline, Follow-up (4-6 weeks)
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.
3 secondary outcomes
Modified Ashworth Scale (MAS) at Baseline and at Follow-up
Time frame: Baseline, Follow-up (4-6 weeks)
Tardieu Scale (TS) at Baseline and at Follow-up
Time frame: Baseline, Follow-up (4-6 weeks)
Passive Range of Motion (PROM) at Baseline and at Follow-up
Time frame: Baseline, Follow-up (4-6 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alberto Esquenazi, MD principal investigator
MossRehab
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dysport in people with Equinovarus; Acquired, run by Albert Einstein Healthcare Network at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-Selected Velocity (SSV) (time frame: Baseline, Follow-up (4-6 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2020.