Safety and Feasibility Evaluation of Robot Assisted Physiotherapy Exercises With REX

Spinal Cord Injury Clinical Trial

— RAPPER II  

Official title:

Safety and Feasibility Evaluation of Robot Assisted Physiotherapy Exercises With REX

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02417532
• Other study ID #: RXPR-0001
• Status: Completed
• Phase: N/A
• Start date: May 2015
• Est. completion date: December 2016

Study information

• Verified date: July 2019
• Source: Rex Bionics Plc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

Device:
• Rehabilitation using REX
Exercises of wheelchair dependent subjects using REX

Locations

Country	Name	City	State
Australia	Austin Health	Heidelberg	Victoria
New Zealand	Rehabilitation Innovation Centre at AUT University	Auckland
New Zealand	Canterbury District Health Board, Burwood Hospital	Christchurch
United Kingdom	East Kent Hospitals University Foundation Trust	Canterbury	Kent
United Kingdom	Physiofunction	Moulton	Northamptonshire
United Kingdom	Royal National Orthopaedic Hospital NHS Trust	Stanmore	Middlesex

Sponsors (2)

Lead Sponsor	Collaborator
Rex Bionics Plc	Generic Devices Consulting, Inc.

Countries where clinical trial is conducted

Australia,  New Zealand,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ability to Transfer	Completion of transfer with supervision or 1 assistant from wheelchair or bed into REX	1 day
Primary	Adverse Events	absence of unexpected serious adverse events	1 day
Primary	Transfer Time	Time it took for participant to transfer into the Rex with or without supervision.	1 day
Secondary	Participant Satisfaction Questionnaire	overall user satisfaction with the device	1 Day
Secondary	Timed up and go Test- Ability to Stand From Chair	The number of seconds required to walk 3 m and turn around and walk back to the chair. (Functional test)	1 Day