Trial Outcomes & Findings for WalkAide Compared to Ankle-Foot Orthosis (AFO) in Stroke Patients (NCT NCT01087957)

NCT ID: NCT01087957

Last Updated: 2014-05-13

Results Overview

Improved ambulation status, specific to increase in gait velocity (m/s)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 495 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2014-05-13

Participant Flow

Participant milestones

Measure	Ankle-Foot Orthosis (AFO) Comparison of WalkAide device against Ankle-Foot Orthosis (AFO) Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)	WalkAide Comparison of WalkAide device against Ankle-Foot Orthosis (AFO) WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)
Overall Study STARTED	253	242
Overall Study COMPLETED	212	187
Overall Study NOT COMPLETED	41	55

Reasons for withdrawal

Measure	Ankle-Foot Orthosis (AFO) Comparison of WalkAide device against Ankle-Foot Orthosis (AFO) Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)	WalkAide Comparison of WalkAide device against Ankle-Foot Orthosis (AFO) WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)
Overall Study Death	2	2
Overall Study Lost to Follow-up	3	4
Overall Study Protocol Violation	13	25
Overall Study Withdrawal by Subject	18	15
Overall Study Physician Decision	5	9

Baseline Characteristics

WalkAide Compared to Ankle-Foot Orthosis (AFO) in Stroke Patients

Baseline characteristics by cohort

Measure	Ankle-Foot Orthosis (AFO) n=253 Participants Comparison of WalkAide device against Ankle-Foot Orthosis (AFO) Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)	WalkAide n=242 Participants Comparison of WalkAide device against Ankle-Foot Orthosis (AFO) WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)	Total n=495 Participants Total of all reporting groups
Age, Continuous	64.30 years STANDARD_DEVIATION 12.01 • n=93 Participants	63.87 years STANDARD_DEVIATION 11.33 • n=4 Participants	64.09 years STANDARD_DEVIATION 11.58 • n=27 Participants
Sex: Female, Male Female	96 Participants n=93 Participants	95 Participants n=4 Participants	191 Participants n=27 Participants
Sex: Female, Male Male	157 Participants n=93 Participants	147 Participants n=4 Participants	304 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=93 Participants	0 Participants n=4 Participants	2 Participants n=27 Participants
Race (NIH/OMB) Asian	3 Participants n=93 Participants	2 Participants n=4 Participants	5 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Black or African American	55 Participants n=93 Participants	55 Participants n=4 Participants	110 Participants n=27 Participants
Race (NIH/OMB) White	187 Participants n=93 Participants	177 Participants n=4 Participants	364 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=93 Participants	8 Participants n=4 Participants	13 Participants n=27 Participants
Time Post Onset of Stroke	6.86 years STANDARD_DEVIATION 6.64 • n=93 Participants	6.90 years STANDARD_DEVIATION 6.43 • n=4 Participants	6.88 years STANDARD_DEVIATION 6.53 • n=27 Participants
Initial Gait Speed	.487 meters/second STANDARD_DEVIATION .21 • n=93 Participants	.449 meters/second STANDARD_DEVIATION .22 • n=4 Participants	.47 meters/second STANDARD_DEVIATION .21 • n=27 Participants
Mini Mental Status Exam	27.49 units on a scale STANDARD_DEVIATION 2.83 • n=93 Participants	27.62 units on a scale STANDARD_DEVIATION 2.44 • n=4 Participants	27.54 units on a scale STANDARD_DEVIATION 2.65 • n=27 Participants
Beck Depression Inventory	8.08 units on a scale STANDARD_DEVIATION 6.58 • n=93 Participants	7.98 units on a scale STANDARD_DEVIATION 6.32 • n=4 Participants	8.05 units on a scale STANDARD_DEVIATION 6.45 • n=27 Participants
Body Mass Index	29.21 kilograms/meters squared STANDARD_DEVIATION 5.08 • n=93 Participants	27.98 kilograms/meters squared STANDARD_DEVIATION 4.93 • n=4 Participants	28.61 kilograms/meters squared STANDARD_DEVIATION 5.04 • n=27 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Intention to treat

Improved ambulation status, specific to increase in gait velocity (m/s)

Outcome measures

Measure	Ankle-Foot Orthosis (AFO) n=253 Participants Comparison of WalkAide device against Ankle-Foot Orthosis (AFO) Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)	WalkAide n=242 Participants Comparison of WalkAide device against Ankle-Foot Orthosis (AFO) WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)
Gait Velocity	.682 m/sec Standard Error .020	.635 m/sec Standard Error .022

PRIMARY outcome

Timeframe: 6 months

Population: Intention to treat

The SIS Composite score is equal to sum of scores for Mobility, ADL/IADL, and Social Participation domains. The questions for each domain are scored on a scale of 1-5, the higher the score the less the impact of Stroke on that domain question. The Mobility domain has 9 questions with scores ranging from 9 to 45. The ADL/IADL domain has 10 questions with scores ranging from 10-150- and the Social Participation domain has 8 question with a score of 8-40.

Outcome measures

Measure	Ankle-Foot Orthosis (AFO) n=253 Participants Comparison of WalkAide device against Ankle-Foot Orthosis (AFO) Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)	WalkAide n=242 Participants Comparison of WalkAide device against Ankle-Foot Orthosis (AFO) WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)
Stroke Impact Scale (SIS) Composite Score	172.7 points Standard Error 2.8	175.0 points Standard Error 2.7

PRIMARY outcome

Timeframe: 6 months

Population: Intention to treat

The device related serious adverse event (SAE) measure is a count of the incidences of adverse events defined as serious (Incapacitating with inability to do work or usual activities; signs and symptoms may be systemic in nature or require medical evaluation and/or treatment; requiring additional hospitalization or intensive care (prolonged hospitalization) and device related (any AE for which a causal relationship between the event and the presence of the device, or the performance of the device system, is at least a reasonable possibility (i.e., the relationship cannot be excluded).

Outcome measures

Measure	Ankle-Foot Orthosis (AFO) n=253 Participants Comparison of WalkAide device against Ankle-Foot Orthosis (AFO) Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)	WalkAide n=242 Participants Comparison of WalkAide device against Ankle-Foot Orthosis (AFO) WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)
Device Related Serious Adverse Events	2 number of device related SAEs	0 number of device related SAEs

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Measure	Ankle-Foot Orthosis (AFO) n=253 Participants Comparison of WalkAide device against Ankle-Foot Orthosis (AFO) Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)	WalkAide n=242 Participants Comparison of WalkAide device against Ankle-Foot Orthosis (AFO) WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)
Six Minute Walk Test	218.6 meters Standard Error 7.6	209.2 meters Standard Error 8.5

SECONDARY outcome

Timeframe: 6 months

The Modified Emory Functional Ambulation Profile (mEFAP) is composed of 5 subtasks: (1) 5 meter walk on a hard Floor, (2) 5 meter walk on a carpeted surface, (3) Timed Up & Go (rising from a chair, a 3-meter walk, and return to a seated position), (4) Navigating a Standardized Obstacle Course, and (5) ascending and descending 4 Stairs. Each is a timed task with the score consisting of the number of seconds required to complete the task. Upon completion of the entire data collection session, a total mEFAP score is calculated by adding the score on each subtask.

Outcome measures

Measure	Ankle-Foot Orthosis (AFO) n=253 Participants Comparison of WalkAide device against Ankle-Foot Orthosis (AFO) Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)	WalkAide n=242 Participants Comparison of WalkAide device against Ankle-Foot Orthosis (AFO) WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)
Modified Emory Functional Ambulation Profile Total Score	479.4 seconds Standard Error 38.3	498.0 seconds Standard Error 32.0

SECONDARY outcome

Timeframe: 6 months

The Modified Emory Functional Ambulation Profile (mEFAP) Floor time sub-task is composed a timed 5 meter walk on a hard Floor. The score consists of the number of seconds required to complete the task. The Floor Time sub-task is added to the other 4 sub-tasks to make up the total mEFAP score.

Outcome measures

Measure	Ankle-Foot Orthosis (AFO) n=253 Participants Comparison of WalkAide device against Ankle-Foot Orthosis (AFO) Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)	WalkAide n=242 Participants Comparison of WalkAide device against Ankle-Foot Orthosis (AFO) WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)
Modified Emory Functional Ambulation Profile Floor Time	56.0 seconds Standard Error 8.0	52.5 seconds Standard Error 3.9

SECONDARY outcome

Timeframe: 6 months

The Modified Emory Functional Ambulation Profile (mEFAP) Carpet time sub-task is composed of a 5 meter walk on a carpeted surface with the score consisting of the number of seconds required to complete the task. The score on the Carpet time sub-task is added to the other 4 sub-tasks to calculate the total mEFAP score .

Outcome measures

Measure	Ankle-Foot Orthosis (AFO) n=253 Participants Comparison of WalkAide device against Ankle-Foot Orthosis (AFO) Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)	WalkAide n=242 Participants Comparison of WalkAide device against Ankle-Foot Orthosis (AFO) WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)
Modified Emory Functional Ambulation Profile Carpet Time	56.1 seconds Standard Error 6.6	57.1 seconds Standard Error 4.4

SECONDARY outcome

Timeframe: 6 months

The Modified Emory Functional Ambulation Profile (mEFAP) Timed up and Go subtask is composed of rising from a chair, walking 3-meters, and returning to a seated position with the score consisting of the number of seconds required to complete the task. The Timed up and Go subtask is added to the other 4 sub-task scores to calculate the total mEFAP score.

Outcome measures

Measure	Ankle-Foot Orthosis (AFO) n=253 Participants Comparison of WalkAide device against Ankle-Foot Orthosis (AFO) Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)	WalkAide n=242 Participants Comparison of WalkAide device against Ankle-Foot Orthosis (AFO) WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)
Modified Emory Functional Ambulation Profile Timed up and Go	131.0 seconds Standard Error 14.7	126.9 seconds Standard Error 9.4

SECONDARY outcome

Timeframe: 6 months

The Modified Emory Functional Ambulation Profile (mEFAP) Obstacle course sub-task is composed navigating a Standardized Obstacle Course with the score consisting of the number of seconds required to complete the task. The obstacle course sub-task is added to the other 4 sub-tasks to calculate the total mEFAP score.

Outcome measures

Measure	Ankle-Foot Orthosis (AFO) n=253 Participants Comparison of WalkAide device against Ankle-Foot Orthosis (AFO) Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)	WalkAide n=242 Participants Comparison of WalkAide device against Ankle-Foot Orthosis (AFO) WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)
Modified Emory Functional Ambulation Profile Obstacle Course	169.8 seconds Standard Error 11.8	182.2 seconds Standard Error 14.8

SECONDARY outcome

Timeframe: 6 months

The Modified Emory Functional Ambulation Profile (mEFAP) Stair time sub-task is composed of ascending and descending 4 Stairs with the score consisting of the number of seconds required to complete the task. The Stair time sub-task score is added to the other 4 subtask scores to calculate the total mEFAP score .

Outcome measures

Measure	Ankle-Foot Orthosis (AFO) n=253 Participants Comparison of WalkAide device against Ankle-Foot Orthosis (AFO) Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)	WalkAide n=242 Participants Comparison of WalkAide device against Ankle-Foot Orthosis (AFO) WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)
Modified Emory Functional Ambulation Profile Stair Time	66.4 seconds Standard Error 5.3	79.3 seconds Standard Error 5.9

SECONDARY outcome

Timeframe: 6 months

The Berg Balance Assessment is a 14 item scale designed to measure balance in adults in a clinical setting. Each item is scored on a scale of 0-4 with a score of 0 indicating the most difficulty with the balance task. A score from 0 to 20 represents balance impairment, 21 to 40 represents acceptable balance, and 41-56 represents good balance.

Outcome measures

Measure	Ankle-Foot Orthosis (AFO) n=253 Participants Comparison of WalkAide device against Ankle-Foot Orthosis (AFO) Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)	WalkAide n=242 Participants Comparison of WalkAide device against Ankle-Foot Orthosis (AFO) WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)
Berg Balance Scale	44.7 units on a scale Standard Error 0.8	44.9 units on a scale Standard Error 0.6

Adverse Events

Ankle-Foot Orthosis (AFO)

Serious events: 17 serious events

Other events: 146 other events

Deaths: 0 deaths

WalkAide

Serious events: 18 serious events

Other events: 162 other events

Deaths: 0 deaths

Serious adverse events

Measure	Ankle-Foot Orthosis (AFO) n=253 participants at risk Comparison of WalkAide device against Ankle-Foot Orthosis (AFO) Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)	WalkAide n=242 participants at risk Comparison of WalkAide device against Ankle-Foot Orthosis (AFO) WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)
Musculoskeletal and connective tissue disorders Fall	0.79% 2/253 • Number of events 2	0.00% 0/242
Musculoskeletal and connective tissue disorders Fracture	0.40% 1/253 • Number of events 1	0.41% 1/242 • Number of events 1
Nervous system disorders Death	0.79% 2/253 • Number of events 2	0.41% 1/242 • Number of events 1
Renal and urinary disorders Death	0.00% 0/253	0.41% 1/242 • Number of events 1
Cardiac disorders Cardiac disorder	1.2% 3/253 • Number of events 5	2.1% 5/242 • Number of events 9
Musculoskeletal and connective tissue disorders Back surgery	0.40% 1/253 • Number of events 1	0.41% 1/242 • Number of events 3
Nervous system disorders TIA or CVA	1.2% 3/253 • Number of events 4	2.1% 5/242 • Number of events 6
Renal and urinary disorders Renal failure/infection	0.40% 1/253 • Number of events 2	1.2% 3/242 • Number of events 5
Gastrointestinal disorders Hospitilization GI disorder	1.6% 4/253 • Number of events 4	0.00% 0/242
Endocrine disorders Hospitilized for abnormal Blood Sugar level	0.00% 0/253	0.41% 1/242 • Number of events 1

Other adverse events

Measure	Ankle-Foot Orthosis (AFO) n=253 participants at risk Comparison of WalkAide device against Ankle-Foot Orthosis (AFO) Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)	WalkAide n=242 participants at risk Comparison of WalkAide device against Ankle-Foot Orthosis (AFO) WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)
Musculoskeletal and connective tissue disorders Falls	35.2% 89/253 • Number of events 173	40.9% 99/242 • Number of events 173
Musculoskeletal and connective tissue disorders Pain in back or Lower Extremity	11.9% 30/253 • Number of events 55	10.7% 26/242 • Number of events 36
Pregnancy, puerperium and perinatal conditions Fatigue/Muscle weakness	3.6% 9/253 • Number of events 18	1.2% 3/242 • Number of events 4
Surgical and medical procedures Other medical conditions	25.7% 65/253 • Number of events 166	28.9% 70/242 • Number of events 149
Skin and subcutaneous tissue disorders Skin Irritation	4.0% 10/253 • Number of events 10	12.0% 29/242 • Number of events 34
Musculoskeletal and connective tissue disorders Muscle soreness	4.3% 11/253 • Number of events 15	5.0% 12/242 • Number of events 15

Additional Information

Helen Rogers PT, PhD

Innovative Neurotronics

Phone: 512-721-1922

Email: hrogers@ininc.us

Results disclosure agreements

• Principal investigator is a sponsor employee (b) Publication- Investigator and Institution agree not to publish the results of the Trial until after the conclusion of the Trial. Investigator agrees to submit to Sponsor copies of any proposed publication at least sixty (60) calendar days in advance of dissemination. Sponsor agrees to review and comment in a timely manner after receipt . All proprietary and/or confidential information of Sponsor must be removed from the Proposed Publication.
• Publication restrictions are in place

Restriction type: OTHER