Cerebrovascular Accident (CVA), Hemiplegia, Stroke
Conditions
Brief summary
The purpose of this study is to evaluate the safety and effectiveness of the Indego exoskeleton as a gait training tool for individuals with hemiplegia due to Cerebrovascular Accident (CVA).
Interventions
DEVICEIndego Exoskeleton
Six study sessions including five Indego training sessions over two weeks.
Sponsors
Shepherd Center, Atlanta GA
Cedars-Sinai Medical Center
Sheltering Arms Physical Rehabilitation Hospitals
Shirley Ryan AbilityLab
Kessler Foundation
St. Charles Hospital
TIRR Memorial Hermann
Rusk Rehabilitation
Parker Hannifin Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Height 5'1 to 6'3 (acceptable height may vary by a few inches depending on femur length) * Weight 250 pounds or less * History of one sided ischemic or hemorrhagic stroke with resultant hemiparesis * Manual Muscle Test (MMT) 4/5 in at least upper extremity * No restrictions on time since stroke (acuity), but all subjects need to be cleared by MD for locomotor training * No other brain abnormalities or neurological diseases/disorders * Has not been diagnosed with more than one stroke * Passive range of motion (PROM) at shoulders, trunk, hips, knees and ankles within functional limits for safe gait * Skin intact where interfaces with Indego device * Modified Ashworth Scale (MAS) for spasticity 3 or less in the lower extremities * Absence of complicating physical or mental conditions as determined by MD that would preclude the individual from safely participating in gait training * Must be able to follow directions and communicate basic needs, demonstrated by a Mini- Mental State Exam (MMSE) score of 18 or greater
Exclusion criteria
* Failure to meet all inclusion criteria * Pregnancy * Colostomy bag * Uncontrolled/untreated hyper- or hypotension
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of Individuals With Hemiplegia Due to CVA Using the Indego Measured Through Reported Subject Adverse Events and Serious Adverse Events | 2 weeks | Safety of individuals with hemiplegia due to CVA using the Indego measured through reported Subject Adverse Events and Serious Adverse Events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Spasticity of Bilateral Upper Extremities (UE) and Lower Extremities (LE) Measured With Modified Ashworth Scale | 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 |
| Activity Measured by Functional Ambulation Category | 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 |
| Gait Speed (Without Indego) Measured With 10 Meter Walk Test | 2 weeks | 10 Meter Walk Test (MWT) without Indego to measure gait speed |
| Pain Measured With Face, Legs, Activity, Cry, Consolability Scale | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 42 |
| Total | 42 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Bladder Issue | 1 |
| Overall Study | Change in Status | 1 |
| Overall Study | High Blood Pressure | 1 |
| Overall Study | Investigator Decision | 2 |
| Overall Study | Lower Extremity Deep Vein Thrombosis | 1 |
Baseline characteristics
| Characteristic | All Enrolled Subjects |
|---|---|
| Acuity of Cerebrovascular Accident (CVA) Acute | 3 Participants |
| Acuity of Cerebrovascular Accident (CVA) Chronic | 33 Participants |
| Acuity of Cerebrovascular Accident (CVA) Subacute | 6 Participants |
| Age, Continuous | 59.8 years STANDARD_DEVIATION 12.4 |
| Race/Ethnicity, Customized Race Asian | 3 Participants |
| Race/Ethnicity, Customized Race Black or African American | 7 Participants |
| Race/Ethnicity, Customized Race Hispanic, Latino or other Spanish origin | 7 Participants |
| Race/Ethnicity, Customized Race White | 25 Participants |
| Severity of Cerebrovascular Accident (CVA) Mild | 4 Participants |
| Severity of Cerebrovascular Accident (CVA) Moderate | 10 Participants |
| Severity of Cerebrovascular Accident (CVA) Severe | 15 Participants |
| Severity of Cerebrovascular Accident (CVA) Very Severe | 13 Participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 48 |
| other Total, other adverse events | 3 / 48 |
| serious Total, serious adverse events | 3 / 48 |
Outcome results
Primary
Safety of Individuals With Hemiplegia Due to CVA Using the Indego Measured Through Reported Subject Adverse Events and Serious Adverse Events
Safety of individuals with hemiplegia due to CVA using the Indego measured through reported Subject Adverse Events and Serious Adverse Events
Time frame: 2 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Enrolled Subjects | 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 |
| All Enrolled Subjects | 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
Activity Measured by Functional Ambulation Category
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
Time frame: 2 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Enrolled Subjects | Activity Measured by Functional Ambulation Category | Average FAC Session 1 | 5 units on a scale | Standard Deviation 2 |
| All Enrolled Subjects | Activity Measured by Functional Ambulation Category | Average FAC Session 6 | 5 units on a scale | Standard Deviation 1 |
Secondary
Gait Speed (Without Indego) Measured With 10 Meter Walk Test
10 Meter Walk Test (MWT) without Indego to measure gait speed
Time frame: 2 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Enrolled Subjects | Gait Speed (Without Indego) Measured With 10 Meter Walk Test | Average 10 MWT time Session 1 | 24.4 seconds | Standard Deviation 20.4 |
| All Enrolled Subjects | Gait Speed (Without Indego) Measured With 10 Meter Walk Test | Average 10 MWT time Session 6 | 19.4 seconds | Standard Deviation 12.9 |
Secondary
Pain Measured With Face, Legs, Activity, Cry, Consolability Scale
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
Time frame: 2 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Enrolled Subjects | Pain Measured With Face, Legs, Activity, Cry, Consolability Scale | Average FLACC Session 1 | 0 units on a scale | Standard Deviation 0 |
| All Enrolled Subjects | Pain Measured With Face, Legs, Activity, Cry, Consolability Scale | Average FLACC Session 6 | 0 units on a scale | Standard Deviation 0 |
Secondary
Spasticity of Bilateral Upper Extremities (UE) and Lower Extremities (LE) Measured With Modified Ashworth Scale
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
Time frame: 2 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Enrolled Subjects | 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 |
| All Enrolled Subjects | 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 |
| All Enrolled Subjects | 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 |
| All Enrolled Subjects | 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 |
| All Enrolled Subjects | 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 |
| All Enrolled Subjects | 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 |
| All Enrolled Subjects | 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 |
| All Enrolled Subjects | 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 |