Evaluating the Indego Exoskeleton for Persons With Hemiplegia Due to CVA

• Sponsor: Parker Hannifin Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03054064
• Collaborator: Shepherd Center, Atlanta GA (Other), Cedars-Sinai Medical Center (Other), Sheltering Arms Physical Rehabilitation Hospitals (Other), Shirley Ryan AbilityLab (Other), Kessler Foundation (Other), St. Charles Hospital (Other), TIRR Memorial Hermann (Other), Rusk Rehabilitation (Other)
• Enrollment: 48
• Locations: 7
• Arm: 1
• Actual Duration (Months): 10.8
• Patients Per Site: 6.9
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Cerebrovascular Accident (CVA); Stroke; Hemiplegia	Device: Indego Exoskeleton	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 48 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Evaluating the Indego Exoskeleton for Persons With Hemiplegia Due to CVA
• Actual Study Start Date: Feb 21, 2017
• Actual Primary Completion Date: Dec 28, 2017
• Actual Study Completion Date: Jan 17, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: All Enrolled Subjects All enrolled subjects will receive gait training with the Indego.	Device: Indego Exoskeleton; Six study sessions including five Indego training sessions over two weeks.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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

2. Activity Measured by Functional Ambulation Category [2 weeks]

   Activity measured by Functional Ambulation Category (FAC) unable to ambulate/ambulates only in parallel bars/requires supervision or physical assistance from > 1 person 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 requires manual contact of one person during ambulation on level surfaces/manual contact is continuous or intermittent light touch to assist balance or coordination 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 ambulation is independent on level surfaces/requires supervision/physical assistance to negotiate stairs, inclines, or unlevel surfaces ambulation is independent on unlevel and level surfaces, stairs and inclines

3. Gait Speed (Without Indego) Measured With 10 Meter Walk Test [2 weeks]

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

4. 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 occasional grimace or frown, withdrawn, disinterested frequent to constant frown, clenched jaw, quivering chin Legs 0: normal position or relaxed uneasy, restless, tense kicking, or legs drawn up Activity 0: lying quietly, normal position, moves easily squirming, shifting back and forth, tense arched, rigid, or jerking Cry 0: no cry (awake or asleep) moans or whimpers, occasional complaint crying steadily, screams or sobs, frequent complaints Consolability 0: content, relaxed reassured by occasional touching, hugging, or being talked to, distractable difficult to console or comfort Minimum score: 0 Maximum Score: 10

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cedars-Sinai Health System	Los Angeles	California	United States	90048
2	Shepherd Center	Atlanta	Georgia	United States	30309
3	Rehabilitation Institute of Chicago (Shirley Ryan AbilityLab)	Chicago	Illinois	United States	60611
4	Kessler Foundation	West Orange	New Jersey	United States	07052
5	St. Charles Hospital	Port Jefferson	New York	United States	11777
6	TIRR Memorial Hermann	Houston	Texas	United States	77030
7	Sheltering Arms Physical Rehabilitation Centers	Mechanicsville	Virginia	United States	23116

Sponsors and Collaborators

• Parker Hannifin Corporation
• 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

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 25, 2016

More Information

Publications

None provided.

• Responsible Party: Parker Hannifin Corporation
• ClinicalTrials.gov Identifier: NCT03054064
• Other Study ID Numbers: PHIND_CVA01
• First Posted: Feb 15, 2017
• Last Update Posted: Apr 7, 2020
• Last Verified: Mar 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Stroke; Hemiplegia

Study Results

Participant Flow

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

Baseline Characteristics

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	All enrolled subjects will receive gait training with the Indego. Indego Exoskeleton: Six study sessions including five Indego training sessions over two weeks.
Overall Participants	42
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	59.8 (12.4)
Sex: Female, Male (Count of Participants)
Female	18 42.9%
Male	24 57.1%
Race/Ethnicity, Customized (Count of Participants)
Asian	3 7.1%
Black or African American	7 16.7%
White	25 59.5%
Hispanic, Latino or other Spanish origin	7 16.7%
Acuity of Cerebrovascular Accident (CVA) (Count of Participants)
Acute	3 7.1%
Subacute	6 14.3%
Chronic	33 78.6%
Severity of Cerebrovascular Accident (CVA) (Count of Participants)
Mild	4 9.5%
Moderate	10 23.8%
Severe	15 35.7%
Very Severe	13 31%

Outcome Measures

1. Primary Outcome

Title	Safety of Individuals With Hemiplegia Due to CVA Using the Indego Measured Through Reported Subject Adverse Events and Serious Adverse Events
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	All enrolled subjects will receive gait training with the Indego. Indego Exoskeleton: Six study sessions including five Indego training sessions over two weeks.
Measure Participants	42
Trial-related Adverse Events	3
Trial-related Serious Adverse Events	0

2. Secondary Outcome

Title	Spasticity of Bilateral Upper Extremities (UE) and Lower Extremities (LE) Measured With Modified Ashworth Scale
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	All enrolled subjects will receive gait training with the Indego. Indego Exoskeleton: Six study sessions including five Indego training sessions over two weeks.
Measure Participants	42
Average MAS Right UE Session 1	1 (1.4)
Average MAS Left UE Session 1	1 (1.5)
Average MAS Right LE Session 1	1 (1.1)
Average MAS Left LE Session 1	1 (1.2)
Average MAS Right UE Session 6	1 (1.4)
Average MAS Left UE Session 6	1 (1.3)
Average MAS Right LE Session 6	1 (1.0)
Average MAS Left LE Session 6	1 (1.1)

3. Secondary Outcome

Title	Activity Measured by Functional Ambulation Category
Description	Activity measured by Functional Ambulation Category (FAC) unable to ambulate/ambulates only in parallel bars/requires supervision or physical assistance from > 1 person 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 requires manual contact of one person during ambulation on level surfaces/manual contact is continuous or intermittent light touch to assist balance or coordination 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 ambulation is independent on level surfaces/requires supervision/physical assistance to negotiate stairs, inclines, or unlevel surfaces ambulation is independent on unlevel and level surfaces, stairs and inclines
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	All enrolled subjects will receive gait training with the Indego. Indego Exoskeleton: Six study sessions including five Indego training sessions over two weeks.
Measure Participants	42
Average FAC Session 1	5 (2)
Average FAC Session 6	5 (1)

4. Secondary Outcome

Title	Gait Speed (Without Indego) Measured With 10 Meter Walk Test
Description	10 Meter Walk Test (MWT) without Indego to measure gait speed
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	All enrolled subjects will receive gait training with the Indego. Indego Exoskeleton: Six study sessions including five Indego training sessions over two weeks.
Measure Participants	42
Average 10 MWT time Session 1	24.4 (20.4)
Average 10 MWT time Session 6	19.4 (12.9)

5. Secondary Outcome

Title	Pain Measured With Face, Legs, Activity, Cry, Consolability Scale
Description	Pain measured with Face, Legs, Activity, Cry, Consolability (FLACC) Scale Face 0: no particular expression or smile occasional grimace or frown, withdrawn, disinterested frequent to constant frown, clenched jaw, quivering chin Legs 0: normal position or relaxed uneasy, restless, tense kicking, or legs drawn up Activity 0: lying quietly, normal position, moves easily squirming, shifting back and forth, tense arched, rigid, or jerking Cry 0: no cry (awake or asleep) moans or whimpers, occasional complaint crying steadily, screams or sobs, frequent complaints Consolability 0: content, relaxed reassured by occasional touching, hugging, or being talked to, distractable difficult to console or comfort Minimum score: 0 Maximum Score: 10
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	All enrolled subjects will receive gait training with the Indego. Indego Exoskeleton: Six study sessions including five Indego training sessions over two weeks.
Measure Participants	42
Average FLACC Session 1	0 (0)
Average FLACC Session 6	0 (0)

Adverse Events

Time Frame	2 weeks
Arm/Group Title	All Enrolled Subjects
Arm/Group Description	All enrolled subjects will receive gait training with the Indego. Indego Exoskeleton: Six study sessions including five Indego training sessions over two weeks.
All Cause Mortality
	All Enrolled Subjects
	Affected / at Risk (%)	# Events
Total	0/48 (0%)
Serious Adverse Events
	All Enrolled Subjects
	Affected / at Risk (%)	# Events
Total	3/48 (6.3%)
General disorders
High blood pressure	1/48 (2.1%)	1
Deep vein thrombosis	1/48 (2.1%)	1
Renal and urinary disorders
Urinary Retention	1/48 (2.1%)	1
Other (Not Including Serious) Adverse Events
	All Enrolled Subjects
	Affected / at Risk (%)	# Events
Total	3/48 (6.3%)
General disorders
Fall	1/48 (2.1%)
Fall	1/48 (2.1%)
Change in status	1/48 (2.1%)
Musculoskeletal and connective tissue disorders
Pain	1/48 (2.1%)
Product Issues
Loss of balance	1/48 (2.1%)
Skin and subcutaneous tissue disorders
Abrasion	1/48 (2.1%)
Abrasion	1/48 (2.1%)
Abrasion	1/48 (2.1%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT 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.