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Trial record 12 of 16 for:    Foot Drop AND meter

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

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ClinicalTrials.gov Identifier: NCT01087957
Recruitment Status : Completed
First Posted : March 16, 2010
Results First Posted : May 13, 2014
Last Update Posted : May 13, 2014
Sponsor:
Information provided by (Responsible Party):
Innovative Neurotronics

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Stroke
Interventions Device: WalkAide
Other: Ankle-Foot Orthosis (AFO)
Enrollment 495

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ankle-Foot Orthosis (AFO) WalkAide
Hide Arm/Group Description

Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)

Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)

Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)

WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)

Period Title: Overall Study
Started 253 242
Completed 212 187
Not Completed 41 55
Reason Not Completed
Death             2             2
Lost to Follow-up             3             4
Protocol Violation             13             25
Withdrawal by Subject             18             15
Physician Decision             5             9
Arm/Group Title Ankle-Foot Orthosis (AFO) WalkAide Total
Hide Arm/Group Description

Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)

Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)

Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)

WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)

Total of all reporting groups
Overall Number of Baseline Participants 253 242 495
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 253 participants 242 participants 495 participants
64.30  (12.01) 63.87  (11.33) 64.09  (11.58)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 253 participants 242 participants 495 participants
Female
96
  37.9%
95
  39.3%
191
  38.6%
Male
157
  62.1%
147
  60.7%
304
  61.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 253 participants 242 participants 495 participants
American Indian or Alaska Native
2
   0.8%
0
   0.0%
2
   0.4%
Asian
3
   1.2%
2
   0.8%
5
   1.0%
Native Hawaiian or Other Pacific Islander
1
   0.4%
0
   0.0%
1
   0.2%
Black or African American
55
  21.7%
55
  22.7%
110
  22.2%
White
187
  73.9%
177
  73.1%
364
  73.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
5
   2.0%
8
   3.3%
13
   2.6%
Time Post Onset of Stroke  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 253 participants 242 participants 495 participants
6.86  (6.64) 6.90  (6.43) 6.88  (6.53)
Initial Gait Speed  
Mean (Standard Deviation)
Unit of measure:  Meters/second
Number Analyzed 253 participants 242 participants 495 participants
.487  (.21) .449  (.22) .47  (.21)
Mini Mental Status Exam   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 253 participants 242 participants 495 participants
27.49  (2.83) 27.62  (2.44) 27.54  (2.65)
[1]
Measure Description: The Mini Mental Status is a measure of cognitive function with a total possible score of 30 points. Any score greater than or equal to 27 points (out of 30) indicates a normal cognition. Below this, scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-24 points) cognitive impairment
Beck Depression Inventory   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 253 participants 242 participants 495 participants
8.08  (6.58) 7.98  (6.32) 8.05  (6.45)
[1]
Measure Description: The Beck Depression inventory is a 21-question multiple-choice self-report inventory used for measuring the severity of depression. Each of the 21 questions is scored on a scale value of 0 to 3. Total score thresholds recommendations are as follows: 0–13: minimal depression; 14–19: mild depression; 20–28: moderate depression; and 29–63: severe depression. Higher total scores indicate more severe depressive symptoms.
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kilograms/meters squared
Number Analyzed 253 participants 242 participants 495 participants
29.21  (5.08) 27.98  (4.93) 28.61  (5.04)
1.Primary Outcome
Title Gait Velocity
Hide Description Improved ambulation status, specific to increase in gait velocity (m/s)
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to treat
Arm/Group Title Ankle-Foot Orthosis (AFO) WalkAide
Hide Arm/Group Description:

Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)

Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)

Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)

WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)

Overall Number of Participants Analyzed 253 242
Mean (Standard Error)
Unit of Measure: m/sec
.682  (.020) .635  (.022)
2.Primary Outcome
Title Stroke Impact Scale (SIS) Composite Score
Hide Description 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.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to treat
Arm/Group Title Ankle-Foot Orthosis (AFO) WalkAide
Hide Arm/Group Description:

Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)

Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)

Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)

WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)

Overall Number of Participants Analyzed 253 242
Mean (Standard Error)
Unit of Measure: points
172.7  (2.8) 175.0  (2.7)
3.Primary Outcome
Title Device Related Serious Adverse Events
Hide Description 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).
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to treat
Arm/Group Title Ankle-Foot Orthosis (AFO) WalkAide
Hide Arm/Group Description:

Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)

Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)

Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)

WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)

Overall Number of Participants Analyzed 253 242
Measure Type: Number
Unit of Measure: number of device related SAEs
2 0
4.Secondary Outcome
Title Six Minute Walk Test
Hide Description [Not Specified]
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ankle-Foot Orthosis (AFO) WalkAide
Hide Arm/Group Description:

Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)

Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)

Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)

WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)

Overall Number of Participants Analyzed 253 242
Mean (Standard Error)
Unit of Measure: meters
218.6  (7.6) 209.2  (8.5)
5.Secondary Outcome
Title Modified Emory Functional Ambulation Profile Total Score
Hide Description 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.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ankle-Foot Orthosis (AFO) WalkAide
Hide Arm/Group Description:

Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)

Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)

Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)

WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)

Overall Number of Participants Analyzed 253 242
Mean (Standard Error)
Unit of Measure: seconds
479.4  (38.3) 498.0  (32.0)
6.Secondary Outcome
Title Modified Emory Functional Ambulation Profile Floor Time
Hide Description 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.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ankle-Foot Orthosis (AFO) WalkAide
Hide Arm/Group Description:

Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)

Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)

Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)

WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)

Overall Number of Participants Analyzed 253 242
Mean (Standard Error)
Unit of Measure: seconds
56.0  (8.0) 52.5  (3.9)
7.Secondary Outcome
Title Modified Emory Functional Ambulation Profile Carpet Time
Hide Description 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 .
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ankle-Foot Orthosis (AFO) WalkAide
Hide Arm/Group Description:

Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)

Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)

Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)

WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)

Overall Number of Participants Analyzed 253 242
Mean (Standard Error)
Unit of Measure: seconds
56.1  (6.6) 57.1  (4.4)
8.Secondary Outcome
Title Modified Emory Functional Ambulation Profile Timed up and Go
Hide Description 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.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ankle-Foot Orthosis (AFO) WalkAide
Hide Arm/Group Description:

Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)

Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)

Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)

WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)

Overall Number of Participants Analyzed 253 242
Mean (Standard Error)
Unit of Measure: seconds
131.0  (14.7) 126.9  (9.4)
9.Secondary Outcome
Title Modified Emory Functional Ambulation Profile Obstacle Course
Hide Description 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.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ankle-Foot Orthosis (AFO) WalkAide
Hide Arm/Group Description:

Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)

Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)

Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)

WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)

Overall Number of Participants Analyzed 253 242
Mean (Standard Error)
Unit of Measure: seconds
169.8  (11.8) 182.2  (14.8)
10.Secondary Outcome
Title Modified Emory Functional Ambulation Profile Stair Time
Hide Description 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 .
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ankle-Foot Orthosis (AFO) WalkAide
Hide Arm/Group Description:

Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)

Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)

Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)

WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)

Overall Number of Participants Analyzed 253 242
Mean (Standard Error)
Unit of Measure: seconds
66.4  (5.3) 79.3  (5.9)
11.Secondary Outcome
Title Berg Balance Scale
Hide Description 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.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ankle-Foot Orthosis (AFO) WalkAide
Hide Arm/Group Description:

Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)

Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)

Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)

WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)

Overall Number of Participants Analyzed 253 242
Mean (Standard Error)
Unit of Measure: units on a scale
44.7  (0.8) 44.9  (0.6)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ankle-Foot Orthosis (AFO) WalkAide
Hide Arm/Group Description

Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)

Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)

Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)

WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)

All-Cause Mortality
Ankle-Foot Orthosis (AFO) WalkAide
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Ankle-Foot Orthosis (AFO) WalkAide
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   17/253 (6.72%)      18/242 (7.44%)    
Cardiac disorders     
Cardiac disorder   3/253 (1.19%)  5 5/242 (2.07%)  9
Endocrine disorders     
Hospitilized for abnormal Blood Sugar level   0/253 (0.00%)  0 1/242 (0.41%)  1
Gastrointestinal disorders     
Hospitilization GI disorder   4/253 (1.58%)  4 0/242 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Fall   2/253 (0.79%)  2 0/242 (0.00%)  0
Fracture   1/253 (0.40%)  1 1/242 (0.41%)  1
Back surgery   1/253 (0.40%)  1 1/242 (0.41%)  3
Nervous system disorders     
Death   2/253 (0.79%)  2 1/242 (0.41%)  1
TIA or CVA   3/253 (1.19%)  4 5/242 (2.07%)  6
Renal and urinary disorders     
Death   0/253 (0.00%)  0 1/242 (0.41%)  1
Renal failure/infection   1/253 (0.40%)  2 3/242 (1.24%)  5
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Ankle-Foot Orthosis (AFO) WalkAide
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   146/253 (57.71%)      162/242 (66.94%)    
Musculoskeletal and connective tissue disorders     
Falls   89/253 (35.18%)  173 99/242 (40.91%)  173
Pain in back or Lower Extremity   30/253 (11.86%)  55 26/242 (10.74%)  36
Muscle soreness   11/253 (4.35%)  15 12/242 (4.96%)  15
Pregnancy, puerperium and perinatal conditions     
Fatigue/Muscle weakness   9/253 (3.56%)  18 3/242 (1.24%)  4
Skin and subcutaneous tissue disorders     
Skin Irritation   10/253 (3.95%)  10 29/242 (11.98%)  34
Surgical and medical procedures     
Other medical conditions  [1]  65/253 (25.69%)  166 70/242 (28.93%)  149
Indicates events were collected by systematic assessment
[1]
Various events involving multiple systems
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
(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.
Results Point of Contact
Name/Title: Helen Rogers PT, PhD
Organization: Innovative Neurotronics
Phone: 512-721-1922
Responsible Party: Innovative Neurotronics
ClinicalTrials.gov Identifier: NCT01087957     History of Changes
Other Study ID Numbers: INSTRIDE
First Submitted: March 15, 2010
First Posted: March 16, 2010
Results First Submitted: February 25, 2014
Results First Posted: May 13, 2014
Last Update Posted: May 13, 2014