Clinical trial NCT02104622: Identify Training Strategies for Progressing Exoskeleton Users Towards Everyday Functional Ambulation
Official title: Identify Training Strategies for Progressing Exoskeleton Users Towards Everyday Functional Ambulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury
Keywords: spinal cord injury
exoskeleton
ambulation
walking
robotics
Lead sponsor: Shirley Ryan AbilityLab
Sponsor class: OTHER
Collaborators: name: U.S. Department of Education
First posted: 2014-04-04
Enrollment: 10
Sex: ALL
Minimum age (years): 12
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Many people with spinal cord injury are no longer able to walk and must use wheelchairs for mobility. These individuals experience greater rates of depression and lower quality of life. Many of these individuals express a strong desire to walk again, and report many psychosocial benefits to being eye to eye with peers in social interactions. Additionally, wheelchairs allow only limited community access, creating an additional obstacle to seeking out meaningful social roles in the community. Currently, there is new technology called robotic exoskeletons that would allow people with spinal cord injury to walk. These robotic exoskeletons also allow for curb, ramp, and stair negotiation, which are critical to community access. Current research has examined training with robotic exoskeletons indoors over level surfaces in clinical settings. This study will examine the potential for everyday use, including ramps, stairs, curbs and indoor and outdoor use.


Eligibility criteria: Inclusion Criteria:

* SCI level C6-8, T1-T12; L1-L5 incomplete or complete
* Be able to physically fit into the exoskeleton device;
* Be able to tolerate upright standing for a minimum of 30 minutes;
* Have sufficient upper body strength to use forearm crutches in standing and during ambulation (including full triceps strength and good hand function);
* Have hip, knee, and ankle range of motion within normal functional limits of walking;
* Have the ability to follow directions and demonstrate learning capacity;
* Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

* Cervical level SCI above C6
* History of severe osteoporosis;
* Weight above 220 pounds;
* Femur length above 47 cm or below 36 cm
* Joint contractures at the hip, knee, or ankle that limit normal range of motion (ROM) during ambulation;
* Cognitive and/or communication disability (e.g. due to brain injury);
* History of significant problems with skin break down or current skin break down;
* Any medical issue that precludes full weight bearing and ambulation (e.g. orthopedic injuries, pain, severe spasticity);
* Pregnancy;
* Cardiovascular conditions such as history of heart attack, high blood pressure, pacemaker, arrhythmia, heart failure, or stroke.

Primary outcomes:
measure: Change in 6 Minute Walk Test from baseline in distance, RPE and oxygen uptake
timeFrame: Session 1 (pre test, initial visit) and Session 20 (post test, between 6-8 weeks)
measure: Change in 10 meter walk test from baseline in gait speed
timeFrame: Session 1 (pre test, initial visit) and Session 20 (post test, between 6-8 weeks)
measure: Time and assistive level to negotiate stairs, ramps, curbs, and turning.
timeFrame: Session 1 (pre test, initial visit) and Session 20 (post test, between 6-8 weeks)
measure: Distance able to reach while standing and sitting
timeFrame: Session 1 (pre test, initial visit) and Session 20 (post test, between 6-8 weeks)
Secondary outcomes:
measure: Patient perception of Quality of Life
timeFrame: Session 1 (pre test, initial visit) and Session 20 (post test, between 6-8 weeks)
measure: The Patient Health Questionnaire
timeFrame: Session 1 (pre test, initial visit) and Session 20 (post test, between 6-8 weeks)
measure: The Psychosocial Impact of Assistive Devices Scale
timeFrame: Session 1 (pre test, initial visit) and Session 20 (post test, between 6-8 weeks)
measure: Activities-specific Balance Confidence Scale
timeFrame: Session 1 (pre test, initial visit) and Session 20 (post test, between 6-8 weeks)
measure: Self reported Spinal Cord Independence Measure in activities of daily living
timeFrame: Session 1 (pre test, initial visit) and Session 20 (post test, between 6-8 weeks)
measure: Pain measure by the Visual Analogue Scale
timeFrame: Session 1 (pre test, initial visit) and Session 20 (post test, between 6-8 weeks)
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rehabilitation Institute of Chicago
state: Illinois
Study officials:
affiliation: Shirley Ryan AbilityLab
name: Arun Jayaraman, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: