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Trial record 6 of 54 for:    Foot Drop

Clinical Study of the L300 Versus Ankle-foot Orthosis (AFO) on Post-Stroke Subjects With Foot Drop (L300)

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ClinicalTrials.gov Identifier: NCT01138995
Recruitment Status : Completed
First Posted : June 8, 2010
Results First Posted : April 28, 2016
Last Update Posted : April 28, 2016
Sponsor:
Collaborators:
Medidata Solutions
University of Cincinnati
Information provided by (Responsible Party):
Bioness Inc

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions Sensorimotor Gait Disorder
Neurologic Ambulation Disorder
Gait, Drop Foot
Poststroke Hemiparesis
Post-Cerebrovascular Accident (CVA) Hemiparesis
Interventions Device: Ness L300
Device: Ankle-foot orthosis
Enrollment 197
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Originial Control Group Original Treatment Group
Hide Arm/Group Description

The Control Group will walk with the a "usual" ankle-foot orthosis (AFO)for 30 weeks. After 30 weeks, the Original Control Group will then be crossed over to walk with the Ness L300 for a total of 12 weeks.

Ness L300: The Ness L300 delivers functional electrical stimulation (FES), which improves gait function, stroke-specific quality of life, functionality, and safety for persons with stroke.

Ness L300: The Original Treatment Group will walk with the Ness L300 for 42 weeks, and the Original Control Group will walk with a "usual" ankle-foot orthosis (AFO)for 30 weeks, then be crossed over to walk with the Ness L300 for a total of 12 weeks.

The Original Treatment Group will walk with the Ness L300 for 42 weeks.

Ness L300: The Ness L300 delivers functional electrical stimulation (FES), which improves gait function, stroke-specific quality of life, functionality, and safety for persons with stroke.

Ness L300: The Original Treatment Group will walk with the Ness L300 for 42 weeks, and the Original Control Group will walk with a "usual" ankle-foot orthosis (AFO)for 30 weeks, then be crossed over to walk with the Ness L300 for a total of 12 weeks.

Period Title: Overall Study
Started 98 99
Completed 88 74
Not Completed 10 25
Arm/Group Title Originial Control Group Original Treatment Group Total
Hide Arm/Group Description

The Control Group will walk with the a "usual" ankle-foot orthosis (AFO)for 30 weeks. After 30 weeks, the Original Control Group will then be crossed over to walk with the Ness L300 for a total of 12 weeks.

Ness L300: The Ness L300 delivers functional electrical stimulation (FES), which improves gait function, stroke-specific quality of life, functionality, and safety for persons with stroke.

Ness L300: The Original Treatment Group will walk with the Ness L300 for 42 weeks, and the Original Control Group will walk with a "usual" ankle-foot orthosis (AFO)for 30 weeks, then be crossed over to walk with the Ness L300 for a total of 12 weeks.

The Original Treatment Group will walk with the Ness L300 for 42 weeks.

Ness L300: The Ness L300 delivers functional electrical stimulation (FES), which improves gait function, stroke-specific quality of life, functionality, and safety for persons with stroke.

Ness L300: The Original Treatment Group will walk with the Ness L300 for 42 weeks, and the Original Control Group will walk with a "usual" ankle-foot orthosis (AFO)for 30 weeks, then be crossed over to walk with the Ness L300 for a total of 12 weeks.

Total of all reporting groups
Overall Number of Baseline Participants 98 99 197
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 98 participants 99 participants 197 participants
61.6  (10.9) 60.7  (12.2) 61.1  (11.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 98 participants 99 participants 197 participants
Female
31
  31.6%
48
  48.5%
79
  40.1%
Male
67
  68.4%
51
  51.5%
118
  59.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 98 participants 99 participants 197 participants
98 99 197
1.Primary Outcome
Title Ten Meter Walk Test (10mWT)
Hide Description Determine gait velocity during a 10 meter walk test for subjects using the L300 versus subjects using a standard "usual" ankle-foot orthosis (AFO). Long term device effect at comfortable gait speed in m/s. Walk test results at 30 weeks will be compared to baseline speed. The mean difference (improvement) between baseline and week 30 will be presented by study arm.
Time Frame Week 30
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat analysis of 197 (98 Control and 99 Treatment) randomized subjects.
Arm/Group Title Originial Control Group Original Treatment Group
Hide Arm/Group Description:
The Control Group will walk with the a "usual" ankle-foot orthosis (AFO)for 30 weeks.

The Original Treatment Group will walk with the Ness L300 for 30 weeks.

The Ness L300 delivers functional electrical stimulation (FES), which improves gait function, stroke-specific quality of life, functionality, and safety for persons with stroke.

Overall Number of Participants Analyzed 98 99
Mean (Standard Deviation)
Unit of Measure: meters per second (m/s)
0.15  (0.14) 0.14  (0.16)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Originial Control Group, Original Treatment Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.75
Comments [Not Specified]
Method Fisher's combination test
Comments Between group difference for entire sample
2.Secondary Outcome
Title Berg Balance Scale (BBS) Score
Hide Description Clinical measurement of balance was recorded using the Berg Balance Scale which is a highly reliable and valid test used among persons with stroke. This Scale consists of 14 items/tasks of increasing difficulty graded on a five-point ordinal scale of zero to four where zero = participant is unable to perform the task and four = participant is independent in performance of task, such that overall total score may range from zero to 56 per participant. Mean Baseline and Mean Week 30 scores were calculated and used to determine change in mean score for each study group.
Time Frame Week 30
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized subjects are included in this analysis to determine change in mean score from Baseline to Week 30 in each study group.
Arm/Group Title Originial Control Group Original Treatment Group
Hide Arm/Group Description:
The Control Group will walk with the a "usual" ankle-foot orthosis (AFO)for 30 weeks.

The Original Treatment Group will walk with the Ness L300 for 30 weeks.

Ness L300: The Ness L300 delivers functional electrical stimulation (FES), which improves gait function, stroke-specific quality of life, functionality, and safety for persons with stroke.

Overall Number of Participants Analyzed 98 99
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.75  (4.62) 1.97  (6.08)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Originial Control Group, Original Treatment Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.022
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
3.Secondary Outcome
Title User Satisfaction
Hide Description Total user satisfaction as measured on 12 item User Satisfaction survey with maximum score 24, minimum 0, where higher score indicated greater satisfaction with device,
Time Frame Week 30
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized subjects were analyzed.
Arm/Group Title Originial Control Group Original Treatment Group
Hide Arm/Group Description:
The Control Group will walk with the a "usual" ankle-foot orthosis (AFO)for 30 weeks.

The Original Treatment Group will walk with the Ness L300 for 30 weeks.

The Ness L300 delivers functional electrical stimulation (FES), which improves gait function, stroke-specific quality of life, functionality, and safety for persons with stroke.

Overall Number of Participants Analyzed 98 99
Mean (Standard Deviation)
Unit of Measure: units on a scale
19.1  (4.0) 21.8  (2.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Originial Control Group, Original Treatment Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame Adverse events were collected for both study arms from Baseline to 30 weeks post-randomization.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Originial Control Group Original Treatment Group
Hide Arm/Group Description The Control Group will walk with the a "usual" ankle-foot orthosis (AFO) for 30 weeks.

The Original Treatment Group will walk with the Ness L300 for 30 weeks.

The Ness L300 delivers functional electrical stimulation (FES), is intended to improve gait function, stroke-specific quality of life, functionality, and safety for persons with stroke.

All-Cause Mortality
Originial Control Group Original Treatment Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Originial Control Group Original Treatment Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/98 (7.14%)      15/99 (15.15%)    
Blood and lymphatic system disorders     
anemia requiring blood transfusion * [1]  0/98 (0.00%)  0 1/99 (1.01%)  1
Cardiac disorders     
stroke/high blood pressure * [1]  1/98 (1.02%)  1 3/99 (3.03%)  3
Gastrointestinal disorders     
bowel obstruction * [1]  0/98 (0.00%)  0 1/99 (1.01%)  1
General disorders     
hospitalization general complaints * [1]  0/98 (0.00%)  0 1/99 (1.01%)  1
Hepatobiliary disorders     
cholecystectomy * [1]  1/98 (1.02%)  1 1/99 (1.01%)  1
Immune system disorders     
cancer * [2]  1/98 (1.02%)  1 0/99 (0.00%)  0
Infections and infestations     
methicillin resistant Staphylococcus aureus * [1]  0/98 (0.00%)  0 1/99 (1.01%)  1
Musculoskeletal and connective tissue disorders     
Bone fracture * [1]  2/98 (2.04%)  2 3/99 (3.03%)  3
Hemiparesis * [1]  1/98 (1.02%)  1 0/99 (0.00%)  0
Psychiatric disorders     
mental depression and anxiety * [1]  0/98 (0.00%)  0 1/99 (1.01%)  1
Renal and urinary disorders     
kidney damage due to dehydration * [1]  0/98 (0.00%)  0 1/99 (1.01%)  1
Reproductive system and breast disorders     
ovarian mass * [1]  0/98 (0.00%)  0 1/99 (1.01%)  1
Respiratory, thoracic and mediastinal disorders     
pneumonia/respiratory * [2]  1/98 (1.02%)  1 1/99 (1.01%)  1
*
Indicates events were collected by non-systematic assessment
[1]
non device related
[2]
non-device related
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Originial Control Group Original Treatment Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   61/98 (62.24%)      82/99 (82.83%)    
Cardiac disorders     
Atrial fibrillation or abnormal heartbeat *  1/98 (1.02%)  1 1/99 (1.01%)  1
Ear and labyrinth disorders     
Vertigo *  0/98 (0.00%)  0 1/99 (1.01%)  1
Eye disorders     
Eye irritation and hemorrhage *  1/98 (1.02%)  2 0/99 (0.00%)  0
Gastrointestinal disorders     
Nausea or abdominal pain *  2/98 (2.04%)  2 2/99 (2.02%)  2
Immune system disorders     
seasonal allergies *  1/98 (1.02%)  1 0/99 (0.00%)  0
Infections and infestations     
blister, folliculitis *  5/98 (5.10%)  5 7/99 (7.07%)  11
Injury, poisoning and procedural complications     
fall with or without injury *  45/98 (45.92%)  71 56/99 (56.57%)  81
Metabolism and nutrition disorders     
gout or diabetes *  2/98 (2.04%)  2 0/99 (0.00%)  0
Musculoskeletal and connective tissue disorders     
joint pain *  21/98 (21.43%)  23 26/99 (26.26%)  33
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
cancer *  0/98 (0.00%)  0 1/99 (1.01%)  1
Nervous system disorders     
hypertonia, headache, dizziness, memory deficit *  8/98 (8.16%)  9 8/99 (8.08%)  10
Psychiatric disorders     
Fear or depression *  1/98 (1.02%)  1 3/99 (3.03%)  3
Renal and urinary disorders     
renal mass *  0/98 (0.00%)  0 1/99 (1.01%)  1
Respiratory, thoracic and mediastinal disorders     
asthma, cough, bronchitis *  2/98 (2.04%)  3 3/99 (3.03%)  3
Skin and subcutaneous tissue disorders     
localized skin redness, rash, irritation *  35/98 (35.71%)  45 45/99 (45.45%)  68
Vascular disorders     
Hypertension and/or flushing *  5/98 (5.10%)  5 4/99 (4.04%)  4
*
Indicates events were collected by non-systematic assessment
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.
Results Point of Contact
Name/Title: Keith McBride, CTO
Organization: Bioness
Phone: 661-362-4866
Responsible Party: Bioness Inc
ClinicalTrials.gov Identifier: NCT01138995     History of Changes
Other Study ID Numbers: CP-L300-0801, Rev. B
First Submitted: June 4, 2010
First Posted: June 8, 2010
Results First Submitted: February 1, 2016
Results First Posted: April 28, 2016
Last Update Posted: April 28, 2016