Equinovarus; Acquired
Conditions
Brief 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. 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.
Interventions
DRUGDysport
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.
Sponsors
Albert Einstein Healthcare Network
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-Selected Velocity (SSV) | 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 | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Modified Ashworth Scale (MAS) at Baseline and at Follow-up | Baseline, Follow-up (4-6 weeks) | 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. |
| Tardieu Scale (TS) at Baseline and at Follow-up | Baseline, Follow-up (4-6 weeks) | 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. |
| Passive Range of Motion (PROM) at Baseline and at Follow-up | Baseline, Follow-up (4-6 weeks) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dysport All Participants | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Dysport |
|---|---|
| Age, Continuous | 52.1 years STANDARD_DEVIATION 17.4 |
| Diagnosis Stroke | 8 Participants |
| Diagnosis TBI | 2 Participants |
| Paretic Side Left | 5 Participants |
| Paretic Side Right | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 6 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 11 |
| other Total, other adverse events | 1 / 11 |
| serious Total, serious adverse events | 0 / 11 |
Outcome results
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.
Time frame: Baseline, Follow-up (4-6 weeks)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Barefoot SSV | Maximal Velocity | Baseline | .59 m/s | Standard Deviation 0.48 |
| Barefoot SSV | Maximal Velocity | Follow-up | .64 m/s | Standard Deviation 0.47 |
| Shoes SSV | Maximal Velocity | Baseline | .71 m/s | Standard Deviation 0.41 |
| Shoes SSV | Maximal Velocity | Follow-up | .78 m/s | Standard Deviation 0.44 |
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.
Time frame: Baseline, Follow-up (4-6 weeks)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Barefoot SSV | Self-Selected Velocity (SSV) | Baseline | 0.41 m/s | Standard Deviation 0.31 |
| Barefoot SSV | Self-Selected Velocity (SSV) | Follow-up | 0.48 m/s | Standard Deviation 0.29 |
| Shoes SSV | Self-Selected Velocity (SSV) | Baseline | .48 m/s | Standard Deviation 0.27 |
| Shoes SSV | Self-Selected Velocity (SSV) | Follow-up | 0.52 m/s | Standard Deviation 0.29 |
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.
Time frame: Baseline, Follow-up (4-6 weeks)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Barefoot SSV | Step-length at Baseline and at Follow-up (Temporal-spatial Data) | Baseline | .47 meters | Standard Deviation 0.3 |
| Barefoot SSV | Step-length at Baseline and at Follow-up (Temporal-spatial Data) | Follow-up | .50 meters | Standard Deviation 0.12 |
| Shoes SSV | Step-length at Baseline and at Follow-up (Temporal-spatial Data) | Baseline | .50 meters | Standard Deviation 0.13 |
| Shoes SSV | Step-length at Baseline and at Follow-up (Temporal-spatial Data) | Follow-up | .51 meters | Standard Deviation 0.14 |
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.
Time frame: Baseline, Follow-up (4-6 weeks)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Barefoot SSV | Modified Ashworth Scale (MAS) at Baseline and at Follow-up | Baseline | 2 score on a scale |
| Barefoot SSV | Modified Ashworth Scale (MAS) at Baseline and at Follow-up | Follow-up | 1 score on a scale |
| Shoes SSV | Modified Ashworth Scale (MAS) at Baseline and at Follow-up | Baseline | 3 score on a scale |
| Shoes SSV | Modified Ashworth Scale (MAS) at Baseline and at Follow-up | Follow-up | 1 score on a scale |
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.
Time frame: Baseline, Follow-up (4-6 weeks)
Population: Clinician moved the ankle at flexion or extension with no effort from the participant.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Barefoot SSV | Passive Range of Motion (PROM) at Baseline and at Follow-up | Baseline | 44 degrees | Standard Deviation 13.3 |
| Barefoot SSV | Passive Range of Motion (PROM) at Baseline and at Follow-up | Follow-up | 50 degrees | Standard Deviation 7.8 |
| Shoes SSV | Passive Range of Motion (PROM) at Baseline and at Follow-up | Baseline | 34 degrees | Standard Deviation 13.1 |
| Shoes SSV | Passive Range of Motion (PROM) at Baseline and at Follow-up | Follow-up | 45.7 degrees | Standard Deviation 9.6 |
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.
Time frame: Baseline, Follow-up (4-6 weeks)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Barefoot SSV | Tardieu Scale (TS) at Baseline and at Follow-up | Baseline | 3 score on a scale |
| Barefoot SSV | Tardieu Scale (TS) at Baseline and at Follow-up | Follow-up | 1 score on a scale |
| Shoes SSV | Tardieu Scale (TS) at Baseline and at Follow-up | Baseline | 3 score on a scale |
| Shoes SSV | Tardieu Scale (TS) at Baseline and at Follow-up | Follow-up | 1 score on a scale |