Trial Outcomes & Findings for Clinical Study of the L300 Versus Ankle-foot Orthosis (AFO) on Post-Stroke Subjects With Foot Drop (NCT NCT01138995)

Last Updated: 2016-04-28

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

197 participants

Primary outcome timeframe

Week 30

Results posted on

2016-04-28

Participant Flow

Participant milestones

Participant milestones
Measure	Originial Control Group 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.	Original Treatment Group 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.
Overall Study STARTED	98	99
Overall Study COMPLETED	88	74
Overall Study NOT COMPLETED	10	25

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Originial Control Group n=98 Participants 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.	Original Treatment Group n=99 Participants 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 n=197 Participants Total of all reporting groups
Age, Continuous	61.6 years STANDARD_DEVIATION 10.9 • n=5 Participants	60.7 years STANDARD_DEVIATION 12.2 • n=7 Participants	61.1 years STANDARD_DEVIATION 11.6 • n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants	48 Participants n=7 Participants	79 Participants n=5 Participants
Sex: Female, Male Male	67 Participants n=5 Participants	51 Participants n=7 Participants	118 Participants n=5 Participants
Region of Enrollment United States	98 participants n=5 Participants	99 participants n=7 Participants	197 participants n=5 Participants

PRIMARY outcome

Timeframe: Week 30

Population: Intent to treat analysis of 197 (98 Control and 99 Treatment) randomized subjects.

Outcome measures

Outcome measures
Measure	Originial Control Group n=98 Participants The Control Group will walk with the a "usual" ankle-foot orthosis (AFO)for 30 weeks.	Original Treatment Group n=99 Participants 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.
Ten Meter Walk Test (10mWT)	0.15 meters per second (m/s) Standard Deviation 0.14	0.14 meters per second (m/s) Standard Deviation 0.16

SECONDARY outcome

Timeframe: Week 30

Population: All randomized subjects are included in this analysis to determine change in mean score from Baseline to Week 30 in each study group.

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.

Outcome measures

Outcome measures
Measure	Originial Control Group n=98 Participants The Control Group will walk with the a "usual" ankle-foot orthosis (AFO)for 30 weeks.	Original Treatment Group n=99 Participants 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.
Berg Balance Scale (BBS) Score	3.75 units on a scale Standard Deviation 4.62	1.97 units on a scale Standard Deviation 6.08

SECONDARY outcome

Timeframe: Week 30

Population: All randomized subjects were analyzed.

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,

Outcome measures

Outcome measures
Measure	Originial Control Group n=98 Participants The Control Group will walk with the a "usual" ankle-foot orthosis (AFO)for 30 weeks.	Original Treatment Group n=99 Participants 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.
User Satisfaction	19.1 units on a scale Standard Deviation 4.0	21.8 units on a scale Standard Deviation 2.9

Adverse Events

Originial Control Group

Serious events: 7 serious events

Other events: 61 other events

Deaths: 0 deaths

Original Treatment Group

Serious events: 15 serious events

Other events: 82 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Originial Control Group n=98 participants at risk The Control Group will walk with the a "usual" ankle-foot orthosis (AFO) for 30 weeks.	Original Treatment Group n=99 participants at risk 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.
Cardiac disorders stroke/high blood pressure	1.0% 1/98 • Number of events 1 • Adverse events were collected for both study arms from Baseline to 30 weeks post-randomization.	3.0% 3/99 • Number of events 3 • Adverse events were collected for both study arms from Baseline to 30 weeks post-randomization.
Hepatobiliary disorders cholecystectomy	1.0% 1/98 • Number of events 1 • Adverse events were collected for both study arms from Baseline to 30 weeks post-randomization.	1.0% 1/99 • Number of events 1 • Adverse events were collected for both study arms from Baseline to 30 weeks post-randomization.
Respiratory, thoracic and mediastinal disorders pneumonia/respiratory	1.0% 1/98 • Number of events 1 • Adverse events were collected for both study arms from Baseline to 30 weeks post-randomization.	1.0% 1/99 • Number of events 1 • Adverse events were collected for both study arms from Baseline to 30 weeks post-randomization.
Immune system disorders cancer	1.0% 1/98 • Number of events 1 • Adverse events were collected for both study arms from Baseline to 30 weeks post-randomization.	0.00% 0/99 • Adverse events were collected for both study arms from Baseline to 30 weeks post-randomization.
Musculoskeletal and connective tissue disorders Bone fracture	2.0% 2/98 • Number of events 2 • Adverse events were collected for both study arms from Baseline to 30 weeks post-randomization.	3.0% 3/99 • Number of events 3 • Adverse events were collected for both study arms from Baseline to 30 weeks post-randomization.
Musculoskeletal and connective tissue disorders Hemiparesis	1.0% 1/98 • Number of events 1 • Adverse events were collected for both study arms from Baseline to 30 weeks post-randomization.	0.00% 0/99 • Adverse events were collected for both study arms from Baseline to 30 weeks post-randomization.
Renal and urinary disorders kidney damage due to dehydration	0.00% 0/98 • Adverse events were collected for both study arms from Baseline to 30 weeks post-randomization.	1.0% 1/99 • Number of events 1 • Adverse events were collected for both study arms from Baseline to 30 weeks post-randomization.
Blood and lymphatic system disorders anemia requiring blood transfusion	0.00% 0/98 • Adverse events were collected for both study arms from Baseline to 30 weeks post-randomization.	1.0% 1/99 • Number of events 1 • Adverse events were collected for both study arms from Baseline to 30 weeks post-randomization.
Reproductive system and breast disorders ovarian mass	0.00% 0/98 • Adverse events were collected for both study arms from Baseline to 30 weeks post-randomization.	1.0% 1/99 • Number of events 1 • Adverse events were collected for both study arms from Baseline to 30 weeks post-randomization.
Gastrointestinal disorders bowel obstruction	0.00% 0/98 • Adverse events were collected for both study arms from Baseline to 30 weeks post-randomization.	1.0% 1/99 • Number of events 1 • Adverse events were collected for both study arms from Baseline to 30 weeks post-randomization.
Infections and infestations methicillin resistant Staphylococcus aureus	0.00% 0/98 • Adverse events were collected for both study arms from Baseline to 30 weeks post-randomization.	1.0% 1/99 • Number of events 1 • Adverse events were collected for both study arms from Baseline to 30 weeks post-randomization.
Psychiatric disorders mental depression and anxiety	0.00% 0/98 • Adverse events were collected for both study arms from Baseline to 30 weeks post-randomization.	1.0% 1/99 • Number of events 1 • Adverse events were collected for both study arms from Baseline to 30 weeks post-randomization.
General disorders hospitalization general complaints	0.00% 0/98 • Adverse events were collected for both study arms from Baseline to 30 weeks post-randomization.	1.0% 1/99 • Number of events 1 • Adverse events were collected for both study arms from Baseline to 30 weeks post-randomization.

Other adverse events

Additional Information

Keith McBride, CTO

Bioness

Phone: 661-362-4866

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	Originial Control Group n=98 participants at risk The Control Group will walk with the a "usual" ankle-foot orthosis (AFO) for 30 weeks.	Original Treatment Group n=99 participants at risk 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.
Skin and subcutaneous tissue disorders localized skin redness, rash, irritation	35.7% 35/98 • Number of events 45 • Adverse events were collected for both study arms from Baseline to 30 weeks post-randomization.	45.5% 45/99 • Number of events 68 • Adverse events were collected for both study arms from Baseline to 30 weeks post-randomization.
Eye disorders Eye irritation and hemorrhage	1.0% 1/98 • Number of events 2 • Adverse events were collected for both study arms from Baseline to 30 weeks post-randomization.	0.00% 0/99 • Adverse events were collected for both study arms from Baseline to 30 weeks post-randomization.
Immune system disorders seasonal allergies	1.0% 1/98 • Number of events 1 • Adverse events were collected for both study arms from Baseline to 30 weeks post-randomization.	0.00% 0/99 • Adverse events were collected for both study arms from Baseline to 30 weeks post-randomization.
Nervous system disorders hypertonia, headache, dizziness, memory deficit	8.2% 8/98 • Number of events 9 • Adverse events were collected for both study arms from Baseline to 30 weeks post-randomization.	8.1% 8/99 • Number of events 10 • Adverse events were collected for both study arms from Baseline to 30 weeks post-randomization.
Gastrointestinal disorders Nausea or abdominal pain	2.0% 2/98 • Number of events 2 • Adverse events were collected for both study arms from Baseline to 30 weeks post-randomization.	2.0% 2/99 • Number of events 2 • Adverse events were collected for both study arms from Baseline to 30 weeks post-randomization.
Vascular disorders Hypertension and/or flushing	5.1% 5/98 • Number of events 5 • Adverse events were collected for both study arms from Baseline to 30 weeks post-randomization.	4.0% 4/99 • Number of events 4 • Adverse events were collected for both study arms from Baseline to 30 weeks post-randomization.
Musculoskeletal and connective tissue disorders joint pain	21.4% 21/98 • Number of events 23 • Adverse events were collected for both study arms from Baseline to 30 weeks post-randomization.	26.3% 26/99 • Number of events 33 • Adverse events were collected for both study arms from Baseline to 30 weeks post-randomization.
Ear and labyrinth disorders Vertigo	0.00% 0/98 • Adverse events were collected for both study arms from Baseline to 30 weeks post-randomization.	1.0% 1/99 • Number of events 1 • Adverse events were collected for both study arms from Baseline to 30 weeks post-randomization.
Psychiatric disorders Fear or depression	1.0% 1/98 • Number of events 1 • Adverse events were collected for both study arms from Baseline to 30 weeks post-randomization.	3.0% 3/99 • Number of events 3 • Adverse events were collected for both study arms from Baseline to 30 weeks post-randomization.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) cancer	0.00% 0/98 • Adverse events were collected for both study arms from Baseline to 30 weeks post-randomization.	1.0% 1/99 • Number of events 1 • Adverse events were collected for both study arms from Baseline to 30 weeks post-randomization.
Metabolism and nutrition disorders gout or diabetes	2.0% 2/98 • Number of events 2 • Adverse events were collected for both study arms from Baseline to 30 weeks post-randomization.	0.00% 0/99 • Adverse events were collected for both study arms from Baseline to 30 weeks post-randomization.
Cardiac disorders Atrial fibrillation or abnormal heartbeat	1.0% 1/98 • Number of events 1 • Adverse events were collected for both study arms from Baseline to 30 weeks post-randomization.	1.0% 1/99 • Number of events 1 • Adverse events were collected for both study arms from Baseline to 30 weeks post-randomization.
Respiratory, thoracic and mediastinal disorders asthma, cough, bronchitis	2.0% 2/98 • Number of events 3 • Adverse events were collected for both study arms from Baseline to 30 weeks post-randomization.	3.0% 3/99 • Number of events 3 • Adverse events were collected for both study arms from Baseline to 30 weeks post-randomization.
Renal and urinary disorders renal mass	0.00% 0/98 • Adverse events were collected for both study arms from Baseline to 30 weeks post-randomization.	1.0% 1/99 • Number of events 1 • Adverse events were collected for both study arms from Baseline to 30 weeks post-randomization.
Infections and infestations blister, folliculitis	5.1% 5/98 • Number of events 5 • Adverse events were collected for both study arms from Baseline to 30 weeks post-randomization.	7.1% 7/99 • Number of events 11 • Adverse events were collected for both study arms from Baseline to 30 weeks post-randomization.
Injury, poisoning and procedural complications fall with or without injury	45.9% 45/98 • Number of events 71 • Adverse events were collected for both study arms from Baseline to 30 weeks post-randomization.	56.6% 56/99 • Number of events 81 • Adverse events were collected for both study arms from Baseline to 30 weeks post-randomization.