Safety and Feasibility Evaluation of Robot Assisted Physiotherapy Exercises With REX (RAPPER II)

Rex Bionics

Status

Completed

Conditions

Spinal Cord Injury

Treatments

Device: Rehabilitation using REX

Study type

Interventional

Funder types

Industry

Identifiers

NCT02417532

RXPR-0001

Details and patient eligibility

About

Prospective, Open label, single arm, non-randomized, non-comparative registry study of Robot-Assisted Physiotherapy Exercises with the REX Robot powered exercise system in patients with Spinal cord or other injury preventing unsupported patient ambulation.

Full description

The objective of this feasibility study is to evaluate the overall device safety when used in Spinal Cord Injury Hospitals or Rehabilitation Centers under the supervision of a physician and/or qualified rehabilitation specialists.

Enrollment

56 patients

Sex

All

Ages

10 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Wheelchair user
Spinal Injury Levels of C4 down to L5
Has no outstanding skin integrity issues that could be effected by the REX device
Should be between approximately 1.42m and 1.93m in height. More specifically, REX is able to accommodate the following limb lengths:
Upper leg length : 380 - 470 mm
Lower leg length : 366 - 470 mm
Heel position (Ankle to hind foot) : 40 - 92 mm
Floor to ankle height (To be measured while wearing the shoe to be used for mobilising in REX) : 96 - 116 mm
Has a skeletal hip width of 380 mm or less (limit imposed by REX)
Is between 40 kg and 100 kg weight (limits imposed by REX)
Has the manual dexterity to work a joystick
Sufficient passive range of motion in the Hip, Knee and Ankle of at least
Hip 90 degrees flexion 15 degrees hip extension 20 degrees abduction 16 degrees adduction
Knee 0 degrees extension 93 degrees flexion
Ankle 20 degrees dorsiflexion (with weight bearing and 10 degrees knee flexion) 22 degrees dorsiflexion (with 93 degrees knee flexion) 10 degrees plantar flexion 9 degrees inversion 9 degrees eversion
Thigh lateral diameter of < 135 mm (230 mm above the knee joint line)
Calf lateral diameter of < 100 mm (90 mm below the knee joint line)
Manual dexterity to work a joystick with or without a T-Bar and use emergency stop button
No contraindications to standing or mobilising
Patients must choose to participate, and must have signed the informed consent document

Exclusion Criteria:

Patients who do not meet inclusion criteria or physician discretion.
Patients with history of impaired cardiac function who have been referred to and reviewed by a medical professional. With a decision made that they should not continue in the trial due to their impaired cardiac function.
Patients contraindicated to walk or stand
Patients with spinal injury outside Inclusion criteria
Withdrawal or refusal to sign informed consent
Any other contraindication based on physician discretion
Known allergy (skin contact) to materials used in Rex