Trial Outcomes & Findings for Assessment of Gait After Dysport Treatment (NCT NCT03501043)

NCT ID: NCT03501043

Last Updated: 2020-03-02

Results Overview

Baseline and follow-up SSV with and without shoes. Distance covers over time at self selected pace. Larger value is better.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 11 participants
• Primary outcome timeframe: Baseline, Follow-up (4-6 weeks)
• Results posted on: 2020-03-02

Participant Flow

Participant milestones

Measure	Dysport All Participants
Overall Study STARTED	11
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Assessment of Gait After Dysport Treatment

Baseline characteristics by cohort

Measure	Dysport n=10 Participants All Participants
Age, Continuous	52.1 years STANDARD_DEVIATION 17.4 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Diagnosis TBI	2 Participants n=5 Participants
Diagnosis Stroke	8 Participants n=5 Participants
Paretic Side Left	5 Participants n=5 Participants
Paretic Side Right	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Barefoot SSV n=10 Participants SSV reported in participants walking barefoot.	Shoes SSV n=10 Participants SSV reported in participants walking in shoes.
Self-Selected Velocity (SSV) Baseline	0.41 m/s Standard Deviation .31	.48 m/s Standard Deviation .27
Self-Selected Velocity (SSV) Follow-up	0.48 m/s Standard Deviation .29	0.52 m/s Standard Deviation .29

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Barefoot SSV n=10 Participants SSV reported in participants walking barefoot.	Shoes SSV n=10 Participants SSV reported in participants walking in shoes.
Maximal Velocity Baseline	.59 m/s Standard Deviation .48	.71 m/s Standard Deviation .41
Maximal Velocity Follow-up	.64 m/s Standard Deviation .47	.78 m/s Standard Deviation .44

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Barefoot SSV n=10 Participants SSV reported in participants walking barefoot.	Shoes SSV n=10 Participants SSV reported in participants walking in shoes.
Step-length at Baseline and at Follow-up (Temporal-spatial Data) Baseline	.47 meters Standard Deviation .30	.50 meters Standard Deviation .13
Step-length at Baseline and at Follow-up (Temporal-spatial Data) Follow-up	.50 meters Standard Deviation .12	.51 meters Standard Deviation .14

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Barefoot SSV n=10 Participants SSV reported in participants walking barefoot.	Shoes SSV n=10 Participants SSV reported in participants walking in shoes.
Modified Ashworth Scale (MAS) at Baseline and at Follow-up Baseline	2 score on a scale Interval 1.63 to 2.0	3 score on a scale Interval 2.0 to 3.0
Modified Ashworth Scale (MAS) at Baseline and at Follow-up Follow-up	1 score on a scale Interval 0.25 to 1.5	1 score on a scale Interval 1.0 to 1.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Barefoot SSV n=10 Participants SSV reported in participants walking barefoot.	Shoes SSV n=10 Participants SSV reported in participants walking in shoes.
Tardieu Scale (TS) at Baseline and at Follow-up Baseline	3 score on a scale Interval 2.0 to 3.0	3 score on a scale Interval 3.0 to 3.0
Tardieu Scale (TS) at Baseline and at Follow-up Follow-up	1 score on a scale Interval 1.0 to 1.0	1 score on a scale Interval 1.0 to 1.0

SECONDARY outcome

Timeframe: Baseline, Follow-up (4-6 weeks)

Population: Clinician moved the ankle at flexion or extension with no effort from the participant.

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.

Outcome measures

Measure	Barefoot SSV n=10 Participants SSV reported in participants walking barefoot.	Shoes SSV n=10 Participants SSV reported in participants walking in shoes.
Passive Range of Motion (PROM) at Baseline and at Follow-up Baseline	44 degrees Standard Deviation 13.3	34 degrees Standard Deviation 13.1
Passive Range of Motion (PROM) at Baseline and at Follow-up Follow-up	50 degrees Standard Deviation 7.8	45.7 degrees Standard Deviation 9.6

Adverse Events

Dysport

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Dysport n=11 participants at risk Participants that received Dysport.
Musculoskeletal and connective tissue disorders Pain	9.1% 1/11 • Number of events 1 • Adverse event was collected at follow-up (4-6 weeks) after the baseline visit.

Additional Information

Stella Lee

MossRehab

Phone: 215-663-6665

Email: leest@einstein.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place