NCT03501043

Assessment of Gait After Dysport Treatment

Completed Phase 4 Results posted Last updated 2 March 2020

What this trial tests

Phase 4 trial testing Dysport in Equinovarus; Acquired in 11 participants. Completed in 22 August 2019.

Timeline

11 June 2018

Primary endpoint
22 August 2019

22 August 2019

Quick facts

Lead sponsor	Albert Einstein Healthcare Network
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	11
Start date	11 June 2018
Primary completion	22 August 2019
Estimated completion	22 August 2019
Sites	1 location across United States

Drugs / interventions tested

• Dysport

Conditions studied

• Equinovarus; Acquired — all drugs for Equinovarus; Acquired →

Sponsor

Albert Einstein Healthcare Network

Who can join

Adults 18 to 100, any sex, with Equinovarus; Acquired. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Self-Selected Velocity (SSV) Primary · 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.

Baseline

Group	Value	95% CI
Barefoot SSV	0.41	± .31
Shoes SSV	.48	± .27

Follow-up

Group	Value	95% CI
Barefoot SSV	0.48	± .29
Shoes SSV	0.52	± .29

Maximal Velocity Primary · 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.

Baseline

Group	Value	95% CI
Barefoot MV	.59	± .48
Shoes MV	.71	± .41

Follow-up

Group	Value	95% CI
Barefoot MV	.64	± .47
Shoes MV	.78	± .44

Step-length at Baseline and at Follow-up (Temporal-spatial Data) Primary · 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.

Baseline

Group	Value	95% CI
Barefoot Step-Length	.47	± .30
Shoes Step-Length	.50	± .13

Follow-up

Group	Value	95% CI
Barefoot Step-Length	.50	± .12
Shoes Step-Length	.51	± .14

Modified Ashworth Scale (MAS) at Baseline and at Follow-up Secondary · 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 t

Baseline

Group	Value	95% CI
MAS Ankle Knee Flexed	2	1.63 – 2
MAS Ankle Knee Extended	3	2 – 3

Follow-up

Group	Value	95% CI
MAS Ankle Knee Flexed	1	0.25 – 1.5
MAS Ankle Knee Extended	1	1 – 1

Tardieu Scale (TS) at Baseline and at Follow-up Secondary · 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.

Baseline

Group	Value	95% CI
TS Ankle Knee Flexed Spasticity Grade	3	2 – 3
TS Ankle Knee Extended Spasticity Grade	3	3 – 3

Follow-up

Group	Value	95% CI
TS Ankle Knee Flexed Spasticity Grade	1	1 – 1
TS Ankle Knee Extended Spasticity Grade	1	1 – 1

Passive Range of Motion (PROM) at Baseline and at Follow-up Secondary · 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.

Baseline

Group	Value	95% CI
PROM Ankle Knee Flexed	44	± 13.3
PROM Ankle Knee Extended	34	± 13.1

Follow-up

Group	Value	95% CI
PROM Ankle Knee Flexed	50	± 7.8
PROM Ankle Knee Extended	45.7	± 9.6

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event was collected at follow-up (4-6 weeks) after the baseline visit.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Dysport

Serious: 0/11 (0%)

Deaths: 0/11

Other adverse events (1 terms — click to expand)

Reaction	System	Dysport
Pain	Musculoskeletal and connective tissue disorders	—

Data from ClinicalTrials.gov NCT03501043 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.