Trial Outcomes & Findings for Evaluating the Indego Exoskeleton for Persons With Hemiplegia Due to CVA (NCT NCT03054064)

NCT ID: NCT03054064

Last Updated: 2020-04-07

Results Overview

Safety of individuals with hemiplegia due to CVA using the Indego measured through reported Subject Adverse Events and Serious Adverse Events

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 48 participants
• Primary outcome timeframe: 2 weeks
• Results posted on: 2020-04-07

Participant Flow

Participant milestones

Measure	All Enrolled Subjects All enrolled subjects will receive gait training with the Indego. Indego Exoskeleton: Six study sessions including five Indego training sessions over two weeks.
Overall Study STARTED	48
Overall Study Screen Failure	2
Overall Study COMPLETED	42
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Measure	All Enrolled Subjects All enrolled subjects will receive gait training with the Indego. Indego Exoskeleton: Six study sessions including five Indego training sessions over two weeks.
Overall Study Lower Extremity Deep Vein Thrombosis	1
Overall Study Investigator Decision	2
Overall Study Bladder Issue	1
Overall Study High Blood Pressure	1
Overall Study Change in Status	1

Baseline Characteristics

Evaluating the Indego Exoskeleton for Persons With Hemiplegia Due to CVA

Baseline characteristics by cohort

Measure	All Enrolled Subjects n=42 Participants All enrolled subjects will receive gait training with the Indego. Indego Exoskeleton: Six study sessions including five Indego training sessions over two weeks.
Age, Continuous	59.8 years STANDARD_DEVIATION 12.4 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian	3 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black or African American	7 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	25 Participants n=5 Participants
Race/Ethnicity, Customized Race · Hispanic, Latino or other Spanish origin	7 Participants n=5 Participants
Acuity of Cerebrovascular Accident (CVA) Acute	3 Participants n=5 Participants
Acuity of Cerebrovascular Accident (CVA) Subacute	6 Participants n=5 Participants
Acuity of Cerebrovascular Accident (CVA) Chronic	33 Participants n=5 Participants
Severity of Cerebrovascular Accident (CVA) Mild	4 Participants n=5 Participants
Severity of Cerebrovascular Accident (CVA) Moderate	10 Participants n=5 Participants
Severity of Cerebrovascular Accident (CVA) Severe	15 Participants n=5 Participants
Severity of Cerebrovascular Accident (CVA) Very Severe	13 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks

Safety of individuals with hemiplegia due to CVA using the Indego measured through reported Subject Adverse Events and Serious Adverse Events

Outcome measures

Measure	All Enrolled Subjects n=42 Participants All enrolled subjects will receive gait training with the Indego. Indego Exoskeleton: Six study sessions including five Indego training sessions over two weeks.
Safety of Individuals With Hemiplegia Due to CVA Using the Indego Measured Through Reported Subject Adverse Events and Serious Adverse Events Trial-related Adverse Events	3 Events
Safety of Individuals With Hemiplegia Due to CVA Using the Indego Measured Through Reported Subject Adverse Events and Serious Adverse Events Trial-related Serious Adverse Events	0 Events

SECONDARY outcome

Timeframe: 2 weeks

Spasticity measured with Modified Ashworth Scale (MAS)

0 - No increase in muscle tone

1 - Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension

1+ - Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the range of movement (ROM) 2 - More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved 3 - Considerable increase in muscle tone, passive movement difficult 4 - Affected part(s) rigid in flexion or extension

Outcome measures

Measure	All Enrolled Subjects n=42 Participants All enrolled subjects will receive gait training with the Indego. Indego Exoskeleton: Six study sessions including five Indego training sessions over two weeks.
Spasticity of Bilateral Upper Extremities (UE) and Lower Extremities (LE) Measured With Modified Ashworth Scale Average MAS Left LE Session 6	1 units on a scale Standard Deviation 1.1
Spasticity of Bilateral Upper Extremities (UE) and Lower Extremities (LE) Measured With Modified Ashworth Scale Average MAS Right UE Session 1	1 units on a scale Standard Deviation 1.4
Spasticity of Bilateral Upper Extremities (UE) and Lower Extremities (LE) Measured With Modified Ashworth Scale Average MAS Left UE Session 1	1 units on a scale Standard Deviation 1.5
Spasticity of Bilateral Upper Extremities (UE) and Lower Extremities (LE) Measured With Modified Ashworth Scale Average MAS Right LE Session 1	1 units on a scale Standard Deviation 1.1
Spasticity of Bilateral Upper Extremities (UE) and Lower Extremities (LE) Measured With Modified Ashworth Scale Average MAS Left LE Session 1	1 units on a scale Standard Deviation 1.2
Spasticity of Bilateral Upper Extremities (UE) and Lower Extremities (LE) Measured With Modified Ashworth Scale Average MAS Right UE Session 6	1 units on a scale Standard Deviation 1.4
Spasticity of Bilateral Upper Extremities (UE) and Lower Extremities (LE) Measured With Modified Ashworth Scale Average MAS Left UE Session 6	1 units on a scale Standard Deviation 1.3
Spasticity of Bilateral Upper Extremities (UE) and Lower Extremities (LE) Measured With Modified Ashworth Scale Average MAS Right LE Session 6	1 units on a scale Standard Deviation 1.0

SECONDARY outcome

Timeframe: 2 weeks

Activity measured by Functional Ambulation Category (FAC)

1. unable to ambulate/ambulates only in parallel bars/requires supervision or physical assistance from > 1 person

2. requires manual contact of one person during ambulation on level surfaces/manual contact is continuous and necessary to support body weight and/or to maintain balance or assist coordination

3. requires manual contact of one person during ambulation on level surfaces/manual contact is continuous or intermittent light touch to assist balance or coordination

4. ambulation occurs on level surfaces without manual contact of another person/requires stand-by guarding of one person because of poor judgment, questionable cardiac status, or the need for verbal cuing to complete the task

5. ambulation is independent on level surfaces/requires supervision/physical assistance to negotiate stairs, inclines, or unlevel surfaces

6. ambulation is independent on unlevel and level surfaces, stairs and inclines

Outcome measures

Measure	All Enrolled Subjects n=42 Participants All enrolled subjects will receive gait training with the Indego. Indego Exoskeleton: Six study sessions including five Indego training sessions over two weeks.
Activity Measured by Functional Ambulation Category Average FAC Session 1	5 units on a scale Standard Deviation 2
Activity Measured by Functional Ambulation Category Average FAC Session 6	5 units on a scale Standard Deviation 1

SECONDARY outcome

Timeframe: 2 weeks

10 Meter Walk Test (MWT) without Indego to measure gait speed

Outcome measures

Measure	All Enrolled Subjects n=42 Participants All enrolled subjects will receive gait training with the Indego. Indego Exoskeleton: Six study sessions including five Indego training sessions over two weeks.
Gait Speed (Without Indego) Measured With 10 Meter Walk Test Average 10 MWT time Session 1	24.4 seconds Standard Deviation 20.4
Gait Speed (Without Indego) Measured With 10 Meter Walk Test Average 10 MWT time Session 6	19.4 seconds Standard Deviation 12.9

SECONDARY outcome

Timeframe: 2 weeks

Pain measured with Face, Legs, Activity, Cry, Consolability (FLACC) Scale Face 0: no particular expression or smile

1. occasional grimace or frown, withdrawn, disinterested

2. frequent to constant frown, clenched jaw, quivering chin

Legs 0: normal position or relaxed

1. uneasy, restless, tense

2. kicking, or legs drawn up

Activity 0: lying quietly, normal position, moves easily

1. squirming, shifting back and forth, tense

2. arched, rigid, or jerking

Cry 0: no cry (awake or asleep)

1. moans or whimpers, occasional complaint

2. crying steadily, screams or sobs, frequent complaints

Consolability 0: content, relaxed

1. reassured by occasional touching, hugging, or being talked to, distractable

2. difficult to console or comfort

Minimum score: 0 Maximum Score: 10

Outcome measures

Measure	All Enrolled Subjects n=42 Participants All enrolled subjects will receive gait training with the Indego. Indego Exoskeleton: Six study sessions including five Indego training sessions over two weeks.
Pain Measured With Face, Legs, Activity, Cry, Consolability Scale Average FLACC Session 6	0 units on a scale Standard Deviation 0
Pain Measured With Face, Legs, Activity, Cry, Consolability Scale Average FLACC Session 1	0 units on a scale Standard Deviation 0

Adverse Events

All Enrolled Subjects

Serious events: 3 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	All Enrolled Subjects n=48 participants at risk All enrolled subjects will receive gait training with the Indego. Indego Exoskeleton: Six study sessions including five Indego training sessions over two weeks.
Renal and urinary disorders Urinary Retention	2.1% 1/48 • Number of events 1 • 2 weeks
General disorders High blood pressure	2.1% 1/48 • Number of events 1 • 2 weeks
General disorders Deep vein thrombosis	2.1% 1/48 • Number of events 1 • 2 weeks

Other adverse events

Measure	All Enrolled Subjects n=48 participants at risk All enrolled subjects will receive gait training with the Indego. Indego Exoskeleton: Six study sessions including five Indego training sessions over two weeks.
Product Issues Loss of balance	2.1% 1/48 • 2 weeks
Musculoskeletal and connective tissue disorders Pain	2.1% 1/48 • 2 weeks
Skin and subcutaneous tissue disorders Abrasion	2.1% 1/48 • 2 weeks
General disorders Fall	2.1% 1/48 • 2 weeks
General disorders Change in status	2.1% 1/48 • 2 weeks

Additional Information

Ryan J. Farris, Ph.D., P.E.

Parker Hannifin Corporation

Phone: 2168963335

Email: ryan.farris@parker.com

Results disclosure agreements

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