Spastic FootPhase 2ChemoCastNCT03903653
Botulinum Toxin A & Weekly Serial Casting in ABI Inpatients With Lower Extremity Spasticity
A Phase 2 study testing Botulinum toxin type A and Serial Casting in people with Spastic Foot, run by Hamilton Health Sciences Corporation.
Trial summary
Effects of Chemodenervation (Botulinum Toxin A) and Serial Casting vs Botulinum Toxin A and without serial casting in Lower Limb Spasticity following ABI. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Spastic Foot
- What is being tested?
- Botulinum toxin type A and Serial Casting
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2019to 1 Dec 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with Acquired Brain Injury (ABI) including but not limited to stroke, traumatic and anoxic brain injury in ABI unit of RRC
- Dorsiflexion limitation of < 10 degrees from neutral and Modified Ashworth Score (MAS) of 2 or 3
- Patients that are on Oral Medication for Spasticity Tx are still allowed to participate (ie. Baclofen)
- Patients both with Bilateral or Unilateral Lower Limb Spasticity are included
- There will be no sex or age restrictions
Who cannot join
- Patients cannot have had Botulinum Toxin A Injections in their Lower Extremities within the past 6 months
- Patients cannot have had any sort of custom bracing or serial casting previously
- Patients with MAS of 4
- Patients with generalized spasticity that require other alternative treatment such as intra-thecal baclofen or surgical intervention
- Patients need to be medically stable (all co-morbidities under control via medical/pharmacological therapy), patients with ongoing co-morbid medical condition that are unmanaged will be excluded.
- Patients whom have skin breakdown in their lower extremities prior to the study will be excluded
- Patients who develop Skin breakdown (Grade 2 or higher) during the course of the study will be removed automatically
About this study
Official title: Effects of Chemodenervation (Botulinum Toxin A) and Serial Casting vs Botulinum Toxin A and Without Serial Casting in Lower Limb Spasticity Following ABI
Effects of Chemodenervation (Botulinum Toxin A) and Serial Casting vs Botulinum Toxin A and without serial casting in Lower Limb Spasticity following ABI.
Read the detailed description
The investigators will be studying the effects of Chemodenervation (Botulinum Toxin A) and Serial Casting vs Botulinum Toxin A and without serial casting in Lower Limb Spasticity following ABI.
patients are randomly divided into two groups: group 1 will undergo botox injection with weekly serial casting group 2 will undergo botox injection with physiotherapy The primary outcome is the effects of the proposed treatment with respect to passive dorsiflexion.
- Conditions
- Spastic Foot
- Being tested
- Botulinum toxin type A, Serial Casting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called Botox
Use of chemodenervation (botulinum toxin A) for treatment of lower extremity spasticity in ABI inpatients with regards to ankle range of motion.
(a total of 350-400 units of botulinum toxin A per treated limb)
Serial CastingDevice
Also called Casting
Using Serial Casting in conjunction with Botox injection for treatment of lower extremity spasticity in ABI inpatients with regards to ankle range of motion.
(a total of 350-400 units of botulinum toxin A per treated limb)
| Study group | Role | What they receive |
|---|---|---|
| Chemodenervation + Serial Casting | Active comparator | in this group a total of 10 patients will undergo Botulinum Toxin A injection and weekly serial casting Intervention = Weekly Serial Casting AND Botulinum Toxin A injection (350-400 units per treated limb) Receives: Drug: Botulinum toxin type A; Device: Serial Casting |
| Chemodenervation without serial casting | Active comparator | in this group a total of 10 patients will undergo Botulinum Toxin A injection. Intervention = Botulinum Toxin A injection (350-400 units per treated limb) alone. Receives: Drug: Botulinum toxin type A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Passive ankle dorsiflexion >10 degrees
we are measuring passive ankle range of motion with respect to dorsiflexion greater than 10 degrees
Measured: 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 posted4 Apr 2019
- Study start1 Sep 2019 (estimated)
- Primary completion1 Nov 2019 (estimated)
- Study completion1 Dec 2019 (estimated)
Why it stopped: unable to enroll patients due to closure of our inpatient units secondary to COVID-19.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spastic FootStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Fateh, Hamilton Health Sciences Corporation
- Investigators
- Seyed Hossein Hosseini, M.D., Principal investigator, Hamilton Health Sciences Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03903653
- Sponsor's protocol ID
- 5301
- Acronym
- ChemoCast
- Status last verified
- Sep 2023
- First submitted
- 2 Dec 2018
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Chemodenervation (Botulinum Toxin A) and Serial Casting vs Botulinum Toxin A and Without Serial Casting in Lower Limb Spasticity Following ABI
- ClinicalTrials.gov ID
- NCT03903653
- Acronym / sponsor ID
- ChemoCast / 5301
- Conditions
- Spastic Foot
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: unable to enroll patients due to closure of our inpatient units secondary to COVID-19.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Study start
- 1 Sep 2019 (estimated)
- Primary completion
- 1 Nov 2019 (estimated)
- Study completion
- 1 Dec 2019 (estimated)
- First posted
- 4 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Effects of Chemodenervation (Botulinum Toxin A) and Serial Casting vs Botulinum Toxin A and without serial casting in Lower Limb Spasticity following ABI.
Detailed description
The investigators will be studying the effects of Chemodenervation (Botulinum Toxin A) and Serial Casting vs Botulinum Toxin A and without serial casting in Lower Limb Spasticity following ABI.
patients are randomly divided into two groups: group 1 will undergo botox injection with weekly serial casting group 2 will undergo botox injection with physiotherapy The primary outcome is the effects of the proposed treatment with respect to passive dorsiflexion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chemodenervation + Serial Casting | Active comparator | Drug: Botulinum toxin type A, Device: Serial Castingin this group a total of 10 patients will undergo Botulinum Toxin A injection and weekly serial casting Intervention = Weekly Serial Casting AND Botulinum Toxin A injection (350-400 units per treated limb) |
| Chemodenervation without serial casting | Active comparator | Drug: Botulinum toxin type Ain this group a total of 10 patients will undergo Botulinum Toxin A injection. Intervention = Botulinum Toxin A injection (350-400 units per treated limb) alone. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with Acquired Brain Injury (ABI) including but not limited to stroke, traumatic and anoxic brain injury in ABI unit of RRC
- Dorsiflexion limitation of < 10 degrees from neutral and Modified Ashworth Score (MAS) of 2 or 3
- Patients that are on Oral Medication for Spasticity Tx are still allowed to participate (ie. Baclofen)
- Patients both with Bilateral or Unilateral Lower Limb Spasticity are included
- There will be no sex or age restrictions
Key exclusion criteria (7 listed)
- Patients cannot have had Botulinum Toxin A Injections in their Lower Extremities within the past 6 months
- Patients cannot have had any sort of custom bracing or serial casting previously
- Patients with MAS of 4
- Patients with generalized spasticity that require other alternative treatment such as intra-thecal baclofen or surgical intervention
- Patients need to be medically stable (all co-morbidities under control via medical/pharmacological therapy), patients with ongoing co-morbid medical condition that are unmanaged will be excluded.
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 |
|---|---|---|
| Botulinum toxin type AAlso: BotoxUse of chemodenervation (botulinum toxin A) for treatment of lower extremity spasticity in ABI inpatients with regards to ankle range of motion. (a total of 350-400 units of botulinum toxin A per treated limb) | Drug | Chemodenervation + Serial Casting, Chemodenervation without serial casting |
| Serial CastingAlso: CastingUsing Serial Casting in conjunction with Botox injection for treatment of lower extremity spasticity in ABI inpatients with regards to ankle range of motion. (a total of 350-400 units of botulinum toxin A per treated limb) | Device | Chemodenervation + Serial Casting |
Primary outcome
Passive ankle dorsiflexion >10 degrees
Time frame: 4-6 weeks
we are measuring passive ankle range of motion with respect to dorsiflexion greater than 10 degrees
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Spastic Foot
Active, not recruiting
Efficacy of Focused Shock Wave Therapy Before and After Botulinum Toxin Injection in Patients With Post-Stroke Spastic Equinus/Equinovarus Foot: A Randomized Clinical Trial
Post-Stroke Spasticity, Spastic Equinovarus Foot
Recruiting
Pilot Study on Muscle, Tendon, and Neural Changes Post-Botulinum Toxin Injections in Post-stroke Spastic Equinovarus
Stroke, Spasticity
Recruiting
Evaluation of Percutaneous Cryoneurotomy Compared to Surgical Open Neurotomy for the Management of Equinovarus Foot Deformity in Patients With Refractory Lower Limb Spasticity After Stroke
Stroke, Equinovarus Foot
RecruitingObservational study
The Effect of AFOs on the EMG of Children With CP
Spastic Cerebral Palsy
Not yet recruiting
Improving STEP in Stroke Patients
Stroke, Hemiplegia Following Ischemic Stroke
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.
Seyed Hossein Hosseini, M.D. principal investigator
Hamilton Health Sciences Corporation
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Botulinum toxin type A and Serial Casting in people with Spastic Foot, run by Hamilton Health Sciences Corporation.
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 5 inclusion and 7 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: withdrawn, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Passive ankle dorsiflexion >10 degrees (time frame: 4-6 weeks). 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 28 Sep 2023.