Clinical trial NCT02417532: Safety and Feasibility Evaluation of Robot Assisted Physiotherapy Exercises With REX
Official title: Safety and Feasibility Evaluation of Robot Assisted Physiotherapy Exercises With REX
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury
Lead sponsor: Rex Bionics Plc
Sponsor class: INDUSTRY
Collaborators: name: Generic Devices Consulting, Inc.
First posted: 2015-04-15
Enrollment: 56
Sex: ALL
Minimum age (years): 10
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Ability to Transfer
timeFrame: 1 day
measure: Adverse Events
timeFrame: 1 day
measure: Transfer Time
timeFrame: 1 day
Secondary outcomes:
measure: Participant Satisfaction Questionnaire
timeFrame: 1 Day
measure: Timed up and go Test- Ability to Stand From Chair
timeFrame: 1 Day
Other outcomes:
Locations:
city: Heidelberg
country: Australia
facility: Austin Health
state: Victoria
city: Auckland
country: New Zealand
facility: Rehabilitation Innovation Centre at AUT University
city: Christchurch
country: New Zealand
facility: Canterbury District Health Board, Burwood Hospital
city: Canterbury
country: United Kingdom
facility: East Kent Hospitals University Foundation Trust
state: Kent
city: Stanmore
country: United Kingdom
facility: Royal National Orthopaedic Hospital NHS Trust
state: Middlesex
city: Moulton
country: United Kingdom
facility: Physiofunction
state: Northamptonshire
Study officials:
affiliation: The Chris Moody Centre
name: Nicholas C Birch, FRCS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Birch N, Graham J, Priestley T, Heywood C, Sakel M, Gall A, Nunn A, Signal N. Results of the first interim analysis of the RAPPER II trial in patients with spinal cord injury: ambulation and functional exercise programs in the REX powered walking aid. J Neuroeng Rehabil. 2017 Jun 19;14(1):60. doi: 10.1186/s12984-017-0274-6.