Trial Outcomes & Findings for Comparison of the Functional Walking Outcomes of Two Settings of a Commercially Available AFO in Adult Stroke Patients (NCT NCT02122783)

Results Overview

walking velocity will be assessed by an electronic temporospatial foot-fall measurement system (gaitmat)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

5 participants

Primary outcome timeframe

8 weeks

Results posted on

2021-10-04

Participant Flow

This is a cross over study - so all participants received both interventions (i.e. were in both study arms).

Participant milestones

Participant milestones
Measure	Conventional Then Experimental Brace Resistance Default intervention Conventional polypropylene custom molded ankle foot orthosis (MAFO) with Lawrence style double channel adjustable joints containing pins/springs Experimental intervention Same MAFO but with ADR (soft polymer) providing brace resistance	Experimental Then Conventional Brace Resistance Experimental Condition Using the novel elastomer (ADR™ ) to provide brace resistance Conventional Condition Same MAFO as above but using pins/springs to provide brace resistance
Overall Study STARTED	2	3
Overall Study COMPLETED	2	2
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Conventional Then Experimental Brace Resistance Default intervention Conventional polypropylene custom molded ankle foot orthosis (MAFO) with Lawrence style double channel adjustable joints containing pins/springs Experimental intervention Same MAFO but with ADR (soft polymer) providing brace resistance	Experimental Then Conventional Brace Resistance Experimental Condition Using the novel elastomer (ADR™ ) to provide brace resistance Conventional Condition Same MAFO as above but using pins/springs to provide brace resistance
Overall Study Adverse Event	0	1

Baseline Characteristics

Comparison of the Functional Walking Outcomes of Two Settings of a Commercially Available AFO in Adult Stroke Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Conventional Then Experimental Brace Resistance n=2 Participants Conventional intervention Conventional brace resistance (using hard stops): Conventional polypropylene custom molded ankle foot orthosis (MAFO) with Lawrence style double channel adjustable joints containing pins/springs Experimental intervention Same MAFO as above but now using ADR™ soft polymer as brace resistance	Experimental Then Conventional Brace Resistance n=3 Participants Experimental intervention Conventional polypropylene custom molded ankle foot orthosis (MAFO) with Lawrence style double channel adjustable joints containing ADR™ soft polymer as brace resistance Conventional intervention Same MAFO as above but now using springs/pins as brace resistance	Total n=5 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	54.0 years STANDARD_DEVIATION 17.0 • n=5 Participants	55.5 years STANDARD_DEVIATION 3.5 • n=7 Participants	54.8 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

walking velocity will be assessed by an electronic temporospatial foot-fall measurement system (gaitmat)

Outcome measures

Outcome measures
Measure	Conventional Brace Resistance (Hardstop) n=5 Participants Default intervention Conventional brace resistance (using hard stops): Conventional polypropylene custom molded ankle foot orthosis (MAFO) with Lawrence style double channel adjustable joints containing pins/springs	ADR™ Brace Resistance n=5 Participants Condition using the novel elastomer to provide brace support ADR™ brace resistance
Self-selected Walking Velocity	0.71 m/s Standard Deviation .39	0.74 m/s Standard Deviation .38

PRIMARY outcome

Timeframe: 8 weeks

step length symmetry will be assessed by an electronic temporospatial foot-fall measurement system (gaitmat). symmetry will result in a ratio of step length on more involved or affected side compared to the less involved or affected (i.e. the "normal") side. as such, the measure will appear to have no units but actually will be a ratio of the same units (in this case, meters to meters).

Outcome measures

Outcome measures
Measure	Conventional Brace Resistance (Hardstop) n=2 Participants Default intervention Conventional brace resistance (using hard stops): Conventional polypropylene custom molded ankle foot orthosis (MAFO) with Lawrence style double channel adjustable joints containing pins/springs	ADR™ Brace Resistance n=3 Participants Condition using the novel elastomer to provide brace support ADR™ brace resistance
Step Length Symmetry	0.98 ratio (m/m) Standard Deviation .24	0.96 ratio (m/m) Standard Deviation .25

PRIMARY outcome

Timeframe: 8 weeks

step time symmetry will be assessed by an electronic temporospatial foot-fall measurement system (gaitmat). symmetry will result in a ratio of step time on more involved or affected side compared to the less involved or affected (i.e. the "normal") side. as such, the measure will appear to have no units but actually will be a ratio of the same units (in this case, seconds to seconds).

Outcome measures

Outcome measures
Measure	Conventional Brace Resistance (Hardstop) n=2 Participants Default intervention Conventional brace resistance (using hard stops): Conventional polypropylene custom molded ankle foot orthosis (MAFO) with Lawrence style double channel adjustable joints containing pins/springs	ADR™ Brace Resistance n=3 Participants Condition using the novel elastomer to provide brace support ADR™ brace resistance
Step Time Symmetry	1.03 ratio (seconds/seconds) Standard Deviation .52	0.99 ratio (seconds/seconds) Standard Deviation .43

SECONDARY outcome

Timeframe: 8 weeks

Population: These data will never be analyzed as they were not collected.

joint kinematics will be assessed using motion capture system

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 8 weeks

Population: These data will never be analyzed as they were not collected.

joint kinematics will be assessed using motion capture and biomechanical force measurement systems

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 8 weeks

Population: These data will never be analyzed as they were not collected.

activity will be measured using accelerometer based step activity monitoring devices

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 8 weeks

Population: These data will never be analyzed as they were not collected.

subject opinions will be measured using surveys and questionnaires

Outcome measures

Outcome data not reported

Adverse Events

Conventional Brace Resistance (Hardstop)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

ADR™ Brace Resistance

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Conventional Brace Resistance (Hardstop) n=5 participants at risk Default intervention Conventional brace resistance (using hard stops): Conventional polypropylene custom molded ankle foot orthosis (MAFO) with Lawrence style double channel adjustable joints containing pins/springs	ADR™ Brace Resistance n=5 participants at risk Condition using the novel elastomer to provide brace support ADR™ brace resistance
Musculoskeletal and connective tissue disorders discomfort while driving, back pain	0.00% 0/5	20.0% 1/5 • Number of events 1

Additional Information

Mukul Talaty

MossRehab

Phone: 2156636682

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place