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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02417532
Recruitment Status : Completed
First Posted : April 15, 2015
Results First Posted : February 17, 2017
Last Update Posted : July 23, 2019
Generic Devices Consulting, Inc.
Information provided by (Responsible Party):
Rex Bionics Plc

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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Device: Rehabilitation using REX Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Safety and Feasibility Evaluation of Robot Assisted Physiotherapy Exercises With REX
Study Start Date : May 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Rehabilitation using REX
Exercises using Rex mobility assist device
Device: Rehabilitation using REX
Exercises of wheelchair dependent subjects using REX

Primary Outcome Measures :
  1. Ability to Transfer [ Time Frame: 1 day ]
    Completion of transfer with supervision or 1 assistant from wheelchair or bed into REX

  2. Adverse Events [ Time Frame: 1 day ]
    absence of unexpected serious adverse events

  3. Transfer Time [ Time Frame: 1 day ]
    Time it took for participant to transfer into the Rex with or without supervision.

Secondary Outcome Measures :
  1. Participant Satisfaction Questionnaire [ Time Frame: 1 Day ]
    overall user satisfaction with the device

  2. Timed up and go Test- Ability to Stand From Chair [ Time Frame: 1 Day ]
    The number of seconds required to walk 3 m and turn around and walk back to the chair. (Functional test)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   10 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02417532

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Australia, Victoria
Austin Health
Heidelberg, Victoria, Australia, 3084
New Zealand
Rehabilitation Innovation Centre at AUT University
Auckland, New Zealand, 1010
Canterbury District Health Board, Burwood Hospital
Christchurch, New Zealand, 4708
United Kingdom
East Kent Hospitals University Foundation Trust
Canterbury, Kent, United Kingdom, CT1 3NG
Royal National Orthopaedic Hospital NHS Trust
Stanmore, Middlesex, United Kingdom, WD6 4QY
Moulton, Northamptonshire, United Kingdom, NN37rr
Sponsors and Collaborators
Rex Bionics Plc
Generic Devices Consulting, Inc.
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Principal Investigator: Nicholas C Birch, FRCS The Chris Moody Centre
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Rex Bionics Plc Identifier: NCT02417532    
Other Study ID Numbers: RXPR-0001
First Posted: April 15, 2015    Key Record Dates
Results First Posted: February 17, 2017
Last Update Posted: July 23, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries