Trial Outcomes & Findings for Investigational Study of the Ekso for High-Dosage Use by Individuals With SCI in a Non-Clinical Environment (NCT NCT02566850)

NCT ID: NCT02566850

Last Updated: 2023-09-28

Results Overview

evaluate the safety of a subject walking with a lay spotter in a non-clinical environment

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 4 participants
• Primary outcome timeframe: through study completion for a maximum possible duration of 42 months
• Results posted on: 2023-09-28

Participant Flow

Participant milestones

Measure	Ekso Users SCI subjects using Ekso Ekso: powered lower extremity exoskeleton
Overall Study STARTED	4
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Ekso Users SCI subjects using Ekso Ekso: powered lower extremity exoskeleton
Overall Study Protocol Violation	1

Baseline Characteristics

Investigational Study of the Ekso for High-Dosage Use by Individuals With SCI in a Non-Clinical Environment

Baseline characteristics by cohort

Measure	Ekso Users n=4 Participants SCI subjects using Ekso Ekso: powered lower extremity exoskeleton
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	39.5 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants
ASIA impairment scale (AIS) AIS A (motor and sensory complete)	3 Participants n=5 Participants
ASIA impairment scale (AIS) AIS B (motor complete)	0 Participants n=5 Participants
ASIA impairment scale (AIS) AIS C (incomplete)	1 Participants n=5 Participants
ASIA impairment scale (AIS) AIS D (incomplete)	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: through study completion for a maximum possible duration of 42 months

Population: One dropout from original 4 participants

evaluate the safety of a subject walking with a lay spotter in a non-clinical environment

Outcome measures

Measure	Ekso Users n=3 Participants SCI subjects using Ekso Ekso: powered lower extremity exoskeleton
Number of Study Participants With Adverse Events	0 Participants

SECONDARY outcome

Timeframe: through study completion for a maximum possible duration of 42 months

Population: One dropout from original 4 participants

Consists of 3 variables: ratings of satisfaction with general quality of life, satisfaction with physical health, and satisfaction with psychological health. All variables are rated on a scale ranging from 0 (completely dissatisfied) to 10 (completely satisfied) with a total of 30 points.

Outcome measures

Measure	Ekso Users n=3 Participants SCI subjects using Ekso Ekso: powered lower extremity exoskeleton
International Spinal Cord Injury Data Sets Quality of Life Basic Data Set Baseline/Pre intervention	21 score on a scale Interval 13.0 to 30.0
International Spinal Cord Injury Data Sets Quality of Life Basic Data Set Post intervention up to 42 months	24.33 score on a scale Interval 21.0 to 27.0

SECONDARY outcome

Timeframe: through study completion for a maximum possible duration of 42 months

Population: One dropout from original 4 participants

evaluate the impact on subject's bowel health, subjective questionnaire. Examined time required for defecation in minutes, with shorter time being more favorable

Outcome measures

Measure	Ekso Users n=3 Participants SCI subjects using Ekso Ekso: powered lower extremity exoskeleton
International Spinal Cord Injury Data Sets Bowel Function Basic Data Set time required for defectation - baseline/pre intervention	28 minutes Interval 6.0 to 60.0
International Spinal Cord Injury Data Sets Bowel Function Basic Data Set time required for defectation post intervention up to 42 months	16.83 minutes Interval 0.0 to 60.0

SECONDARY outcome

Timeframe: through study completion for a maximum possible duration of 42 months

Population: One dropout from original 4 participants

evaluate the impact on subject's bladder health, subjective feedback and written answers collected, no numerical scoring is part of this exam. This data set asks the following questions: Urinary tract impairment unrelated to spinal cord lesion? Awareness of the need to empty the bladder? How does bladder emptying occur? Average number of voluntary bladder emptyings per 24 hours during the last week? Any involuntary urine leakage (urinary incontinence) within the last four weeks? Collecting appliances for urinary incontinence? Any drugs with possible influence on the urinary tract within the last four weeks? Surgical procedures on the urinary tract? Any change in lower urinary tract symptoms within the last year?

Outcome measures

Measure	Ekso Users n=3 Participants SCI subjects using Ekso Ekso: powered lower extremity exoskeleton
International Spinal Cord Injury Data Sets Bladder Function Basic Data Set - Number of Participants Who Reported Changes in Bladder Function	3 Participants

SECONDARY outcome

Timeframe: through study completion for a maximum possible duration of 42 months

Population: One dropout from original 4 participants

evaluate the impact on subject's spasticity, assessed Elbow Flexors / Extensors, Wrist Flexors / Extensors, Hip Flexors / Extensors, Hip Abductors, Knee Flexors / Extensors, Ankle Plantar Flexors, Ankle Invertors and totaled spasticity for each group (0-5 for right and left) to total between 0 and 70. Higher scores for each muscle group indicate more rigid spasticity, and higher total score indicates more muscle groups involved.

Outcome measures

Measure	Ekso Users n=3 Participants SCI subjects using Ekso Ekso: powered lower extremity exoskeleton
Spasticity as Tested by the Modified Ashworth Scale baseline/pre intervention	0.67 units on a scale Interval 0.0 to 2.0
Spasticity as Tested by the Modified Ashworth Scale post intervention up to 42 months	4.67 units on a scale Interval 0.0 to 14.0

SECONDARY outcome

Timeframe: through study completion for a maximum possible duration of 42 months

Population: One dropout from original 4 participants

evaluate the impact on subject's pain. Totaled the following questions with scales from 0-10 for a total score ranging from 0-50. For each question, 0 = "No interference", 10 = "Extreme interference"

"How much has pain changed your ability to take part in recreational and other social activities?" "How much has pain changed the amount of satisfaction or enjoyment you get from family related activities?" "In general, how much has pain interfered with your day to day activities in the last week?" "In general, how much has pain interfered with your overall mood in the past week?" "In general, how much has pain interfered with your ability to get a good night's sleep?"

Outcome measures

Measure	Ekso Users n=3 Participants SCI subjects using Ekso Ekso: powered lower extremity exoskeleton
International Spinal Cord Injury Data Sets baseline/Pre intervention	13.67 units on a scale Interval 0.0 to 27.0
International Spinal Cord Injury Data Sets post intervention up to 42 months	4.67 units on a scale Interval 0.0 to 14.0

SECONDARY outcome

Timeframe: through study completion for a maximum possible duration of 42 months

Population: One dropout from original 4 participants

evaluate the impact on subject's functional abilities in 3 domains (self care, respiration and sphicter management, mobility) on a scale from 0-100. Each of the 17 total questions have multiple options that are scored in different values. Some questions range from 0-1 points, while others range from 0-2,0-3, 0-5, 0-8, 0-6,0-10, or 0-15. Higher values for each question, and overall, indicate more independence with the task, while lower scores indicates requiring of more assistance.

Outcome measures

Measure	Ekso Users n=3 Participants SCI subjects using Ekso Ekso: powered lower extremity exoskeleton
Spinal Cord Independence Measure (SCIM) II Post intervention up to 42 months	74 score on a scale Interval 72.0 to 76.0
Spinal Cord Independence Measure (SCIM) II baseline/Pre intervention	71.67 score on a scale Interval 68.0 to 75.0

SECONDARY outcome

Timeframe: through study completion for a maximum possible duration of 42 months

evaluate the impact on subject's muscle strength. Total upper and lower extremity motor scores (0-5 for right and left) for each of the following muscle groups for a total of 120 points. For each muscle group, 0 is defined as no palpable contraction, while 5 is full strength.

Shoulder Flexion Shoulder Extension Elbow Flexion Elbow Extension Wrist Extension Gross Grip Strength Hip Flexion Hip Extension Hip Abduction Knee Extension Ankle Dorsiflexion Ankle Plantar Flexion

Outcome measures

Measure	Ekso Users n=3 Participants SCI subjects using Ekso Ekso: powered lower extremity exoskeleton
Strength Via Upper and Lower Extremity Motor Scors (ISNCSCI Exam) baseline/Pre intervention	69 score on a scale Interval 60.0 to 87.0
Strength Via Upper and Lower Extremity Motor Scors (ISNCSCI Exam) post intervention up to 42 months	72.3 score on a scale Interval 60.0 to 97.0

SECONDARY outcome

Timeframe: through study completion for a maximum possible duration of 42 months

evaluate the impact on subject's effort while walking. Measure taken for each session on scale from 6-20. Average was taken from each participant over their total number of sessions. Higher scores on the Borg indicates the participants feels like they are working harder.

Outcome measures

Measure	Ekso Users n=3 Participants SCI subjects using Ekso Ekso: powered lower extremity exoskeleton
Borg Perceived Rate of Exertion	8.98 score on a scale Interval 7.99 to 10.93

SECONDARY outcome

Timeframe: through study completion for a maximum possible duration of 42 months

Population: one dropout

Number of months that a participant utilized the Ekso in their home with a lay spotter

Outcome measures

Measure	Ekso Users n=3 Participants SCI subjects using Ekso Ekso: powered lower extremity exoskeleton
Length of Participation in Study	31.67 months Interval 15.0 to 42.0

SECONDARY outcome

Timeframe: Through study completion for a maximum possible duration of 42 months

Population: one dropout

Frequency of secondary health complications as reported by participants

Outcome measures

Measure	Ekso Users n=3 Participants SCI subjects using Ekso Ekso: powered lower extremity exoskeleton
Secondary Health Conditions Participants who reported a UTI during study duration	0 Participants
Secondary Health Conditions Participants who reported a pressure sore during study duration	0 Participants
Secondary Health Conditions Participants who reported no secondary health conditions during study duration	3 Participants

Adverse Events

Ekso Users

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Katherine Strausser PhD

Ekso Bionics

Phone: (510) 529-2529

Email: kstrausser@eksobionics.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place