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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Innovative Neurotronics
ClinicalTrials.gov Identifier:
NCT01087957
First received: March 15, 2010
Last updated: April 14, 2014
Last verified: April 2014
Results First Received: February 25, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Stroke
Interventions: Device: WalkAide
Other: Ankle-Foot Orthosis (AFO)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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)


Participant Flow:   Overall Study
    Ankle-Foot Orthosis (AFO)     WalkAide  
STARTED     253     242  
COMPLETED     212     187  
NOT COMPLETED     41     55  
Death                 2                 2  
Lost to Follow-up                 3                 4  
Protocol Violation                 13                 25  
Withdrawal by Subject                 18                 15  
Physician Decision                 5                 9  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
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)

Total Total of all reporting groups

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



  Outcome Measures
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1.  Primary:   Gait Velocity   [ Time Frame: 6 months ]

2.  Primary:   Stroke Impact Scale (SIS) Composite Score   [ Time Frame: 6 months ]

3.  Primary:   Device Related Serious Adverse Events   [ Time Frame: 6 months ]

4.  Secondary:   Six Minute Walk Test   [ Time Frame: 6 months ]

5.  Secondary:   Modified Emory Functional Ambulation Profile Total Score   [ Time Frame: 6 months ]

6.  Secondary:   Modified Emory Functional Ambulation Profile Floor Time   [ Time Frame: 6 months ]

7.  Secondary:   Modified Emory Functional Ambulation Profile Carpet Time   [ Time Frame: 6 months ]

8.  Secondary:   Modified Emory Functional Ambulation Profile Timed up and Go   [ Time Frame: 6 months ]

9.  Secondary:   Modified Emory Functional Ambulation Profile Obstacle Course   [ Time Frame: 6 months ]

10.  Secondary:   Modified Emory Functional Ambulation Profile Stair Time   [ Time Frame: 6 months ]

11.  Secondary:   Berg Balance Scale   [ Time Frame: 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Helen Rogers PT, PhD
Organization: Innovative Neurotronics
phone: 512-721-1922
e-mail: hrogers@ininc.us


Publications of Results:

Responsible Party: Innovative Neurotronics
ClinicalTrials.gov Identifier: NCT01087957     History of Changes
Other Study ID Numbers: INSTRIDE
Study First Received: March 15, 2010
Results First Received: February 25, 2014
Last Updated: April 14, 2014
Health Authority: United States: Food and Drug Administration