Evaluating the Indego Exoskeleton for Persons With Hemiplegia Due to CVA

Stroke Clinical Trial

Official title:

Evaluating the Indego Exoskeleton for Persons With Hemiplegia Due to CVA

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03054064
• Other study ID #: PHIND_CVA01
• Status: Completed
• Phase: N/A
• Start date: February 21, 2017
• Est. completion date: January 17, 2018

Study information

• Verified date: March 2020
• Source: Parker Hannifin Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: January 17, 2018
• Est. primary completion date: December 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebrovascular Accident (CVA)
• Hemiplegia
• Stroke

Intervention

Device:
• Indego Exoskeleton
Six study sessions including five Indego training sessions over two weeks.

Locations

Country	Name	City	State
United States	Shepherd Center	Atlanta	Georgia
United States	Rehabilitation Institute of Chicago (Shirley Ryan AbilityLab)	Chicago	Illinois
United States	TIRR Memorial Hermann	Houston	Texas
United States	Cedars-Sinai Health System	Los Angeles	California
United States	Sheltering Arms Physical Rehabilitation Centers	Mechanicsville	Virginia
United States	St. Charles Hospital	Port Jefferson	New York
United States	Kessler Foundation	West Orange	New Jersey

Sponsors (9)

Lead Sponsor	Collaborator
Parker Hannifin Corporation	Cedars-Sinai Medical Center, Kessler Foundation, Rusk Rehabilitation, Sheltering Arms Physical Rehabilitation Hospitals, Shepherd Center, Atlanta GA, Shirley Ryan AbilityLab, St. Charles Hospital, TIRR Memorial Hermann

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	2 weeks
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	2 weeks
Secondary	Activity Measured by Functional Ambulation Category	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	2 weeks
Secondary	Gait Speed (Without Indego) Measured With 10 Meter Walk Test	10 Meter Walk Test (MWT) without Indego to measure gait speed	2 weeks
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; 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	2 weeks