Identify Training Strategies for Progressing Exoskeleton Users Towards Everyday Functional Ambulation

NCT ID: NCT02104622

Last Updated: 2020-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2020-01-31

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.

Conditions

Spinal Cord Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ReWalk training

Group Type: EXPERIMENTAL

ReWalk Rehabilitation 2.0

Intervention Type: DEVICE

Interventions

ReWalk Rehabilitation 2.0

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

U.S. Department of Education

FED

Sponsor Role: collaborator

Shirley Ryan AbilityLab

OTHER

Sponsor Role: lead

Responsible Party

Arun Jayaraman, PT, PhD

Research Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Arun Jayaraman, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

Shirley Ryan AbilityLab

Locations

Rehabilitation Institute of Chicago

Chicago, Illinois, United States

Countries

United States

Other Identifiers

89259

Identifier Type: -

Identifier Source: org_study_id