Trial Outcomes & Findings for Ankle-foot Orthoses for Peripheral Artery Disease (NCT NCT02280200)

NCT ID: NCT02280200

Last Updated: 2019-07-31

Results Overview

In the Walking Impairment Questionnaire distance subcategory, participants are asked to rate the degree of difficulty walking specific distances on a scale from 0 to 4. A score of 0 indicates the inability to walk the distance specified by the question while a score of 4 represents no difficulty. The graded sub-score is multiplied by a pre-specified weight for each sub-category: distance, speed, and number of flights of stairs. The products of these subscores are summed and divided by the maximum possible score to obtain a percent score, ranging from 0 (inability to perform item) to 100 (no difficulty in performing item).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 31 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2019-07-31

Participant Flow

Participant milestones

Measure	AFO to Improve Outcomes Patients completed graded treadmill testing, followed by 12 weeks of unstructured community-based walking using the AFO ad libitum	Historical Controls Historical PAD control group (n = 10) received upfront advice to walk at home with no intervention
Overall Study STARTED	15	13
Overall Study COMPLETED	12	10
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ankle-foot Orthoses for Peripheral Artery Disease

Baseline characteristics by cohort

Measure	AFO to Improve Outcomes n=15 Participants open label, non-interventional design (all patients who volunteer for trial receive AFO) AFO to improve outcomes: Ankle foot orthoses (AFO) are light-weight, low profile carbon fiber devices that store and release energy during ambulation. The AFO, in combination with standard of care advice to walk more, will be used to determine if there is any improvement in PAD patient outcomes.	Historical Controls n=10 Participants Historical PAD control group (n = 10) received upfront advice to walk at home with no intervention	Total n=25 Participants Total of all reporting groups
Age, Categorical >=65 years	9 Participants n=5 Participants	3 Participants n=7 Participants	12 Participants n=5 Participants
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	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Age, Continuous	67.4 years STANDARD_DEVIATION 12.4 • n=5 Participants	63.1 years STANDARD_DEVIATION 6.7 • n=7 Participants	65.7 years STANDARD_DEVIATION 10.5 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants	5 Participants n=7 Participants	19 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants	10 participants n=7 Participants	25 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

In the Walking Impairment Questionnaire distance subcategory, participants are asked to rate the degree of difficulty walking specific distances on a scale from 0 to 4. A score of 0 indicates the inability to walk the distance specified by the question while a score of 4 represents no difficulty. The graded sub-score is multiplied by a pre-specified weight for each sub-category: distance, speed, and number of flights of stairs. The products of these subscores are summed and divided by the maximum possible score to obtain a percent score, ranging from 0 (inability to perform item) to 100 (no difficulty in performing item).

Outcome measures

Measure	AFO to Improve Outcomes n=15 Participants open label, non-interventional design (all patients who volunteer for trial receive AFO) AFO to improve outcomes: Ankle foot orthoses (AFO) are light-weight, low profile carbon fiber devices that store and release energy during ambulation. The AFO, in combination with standard of care advice to walk more, will be used to determine if there is any improvement in PAD patient outcomes.	Historical Controls n=10 Participants Historical PAD control group (n = 10) received upfront advice to walk at home with no intervention
Change in WIQ Distance Subscore	22.7 Scale units Standard Deviation 24.5	-7.2 Scale units Standard Deviation 13.2

PRIMARY outcome

Timeframe: 12 weeks

In the Walking Impairment Questionnaire speed subcategory, participants are asked to rate the degree of difficulty walking one block at specific speeds, ranging from walking slowly to jogging, on a scale from 0 to 4. A score of 0 indicates the inability to walk the distance specified by the question while a score of 4 represents no difficulty. The graded sub-score is multiplied by a pre-specified weight for each sub-category: distance, speed, and number of flights of stairs. The products of these subscores are summed and divided by the maximum possible score to obtain a percent score, ranging from 0 (inability to perform item) to 100 (no difficulty in performing item).

Outcome measures

Measure	AFO to Improve Outcomes n=15 Participants open label, non-interventional design (all patients who volunteer for trial receive AFO) AFO to improve outcomes: Ankle foot orthoses (AFO) are light-weight, low profile carbon fiber devices that store and release energy during ambulation. The AFO, in combination with standard of care advice to walk more, will be used to determine if there is any improvement in PAD patient outcomes.	Historical Controls n=10 Participants Historical PAD control group (n = 10) received upfront advice to walk at home with no intervention
Change in WIQ Speed Subscore	14.9 Scale units Standard Deviation 17.1	-7.5 Scale units Standard Deviation 19.6

PRIMARY outcome

Timeframe: 12 weeks

In the Walking Impairment Questionnaire stair-climbing subcategory, participants are asked to rate the degree of difficulty climbing a specified number of stair flights, ranging from 1 to 3 stair flights, on a graded scale of 0 to 4. A score of 0 indicates the inability to climb the flights specified by the question while a score of 4 represents no difficulty. The graded sub-score is multiplied by a pre-specified weight for each sub-category: distance, speed, and number of flights of stairs. The products of these subscores are summed and divided by the maximum possible score to obtain a percent score, ranging from 0 (inability to perform item) to 100 (no difficulty in performing item).

Outcome measures

Measure	AFO to Improve Outcomes n=15 Participants open label, non-interventional design (all patients who volunteer for trial receive AFO) AFO to improve outcomes: Ankle foot orthoses (AFO) are light-weight, low profile carbon fiber devices that store and release energy during ambulation. The AFO, in combination with standard of care advice to walk more, will be used to determine if there is any improvement in PAD patient outcomes.	Historical Controls n=10 Participants Historical PAD control group (n = 10) received upfront advice to walk at home with no intervention
Change in WIQ Stair-Climbing Subscore	18.9 percent of score Standard Deviation 23.5	0 percent of score Standard Deviation 37.2

PRIMARY outcome

Timeframe: 12 weeks

Change in Medical Outcomes Study Short Form 36-item questionnaire, Physical Component Summary The SF-36 has eight scaled subscores (Vitality, Physical functioning, Bodily pain, General health perceptions, Physical role functioning, Emotional role functioning, Social role functioning, Mental health). These subscores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability.

Outcome measures

Measure	AFO to Improve Outcomes n=15 Participants open label, non-interventional design (all patients who volunteer for trial receive AFO) AFO to improve outcomes: Ankle foot orthoses (AFO) are light-weight, low profile carbon fiber devices that store and release energy during ambulation. The AFO, in combination with standard of care advice to walk more, will be used to determine if there is any improvement in PAD patient outcomes.	Historical Controls n=10 Participants Historical PAD control group (n = 10) received upfront advice to walk at home with no intervention
Change in SF-36 PCS	2.9 Scale units Standard Deviation 5	2.1 Scale units Standard Deviation 6.7

PRIMARY outcome

Timeframe: 12 weeks

Change in Medical Outcomes Study Short Form 36-item questionnaire, Mental Component Summary The SF-36 has eight scaled subscores (Vitality, Physical functioning, Bodily pain, General health perceptions, Physical role functioning, Emotional role functioning, Social role functioning, Mental health). These subscores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability.

Outcome measures

Measure	AFO to Improve Outcomes n=15 Participants open label, non-interventional design (all patients who volunteer for trial receive AFO) AFO to improve outcomes: Ankle foot orthoses (AFO) are light-weight, low profile carbon fiber devices that store and release energy during ambulation. The AFO, in combination with standard of care advice to walk more, will be used to determine if there is any improvement in PAD patient outcomes.	Historical Controls n=10 Participants Historical PAD control group (n = 10) received upfront advice to walk at home with no intervention
Change in SF-36 MCS	4.3 Scale units Standard Deviation 7.6	-1.1 Scale units Standard Deviation 6

Adverse Events

AFO to Improve Outcomes

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Historical Controls

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	AFO to Improve Outcomes n=15 participants at risk Patients completed graded treadmill testing, followed by 12 weeks of unstructured community-based walking using the AFO ad libitum AFO to improve outcomes: Ankle foot orthoses (AFO) are light-weight, low profile carbon fiber devices that store and release energy during ambulation. The AFO, in combination with standard of care advice to walk more, will be used to determine if there is any improvement in PAD patient outcomes.	Historical Controls n=10 participants at risk Historical PAD control group (n = 10) received upfront advice to walk at home with no intervention
Respiratory, thoracic and mediastinal disorders Chronic Respiratory Problems	6.7% 1/15 • 12 weeks	0.00% 0/10 • 12 weeks
Respiratory, thoracic and mediastinal disorders End-stage COPD	6.7% 1/15 • 12 weeks	0.00% 0/10 • 12 weeks
Infections and infestations Lower Limb Skin Infection	6.7% 1/15 • 12 weeks	0.00% 0/10 • 12 weeks

Other adverse events

Adverse event data not reported

Additional Information

Ryan Mays PhD, MPH, MS

University of Minnesota

Phone: 612-625-0430

Email: rjmays@umn.edu

Results disclosure agreements

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