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

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.
ClinicalTrials.gov Identifier: NCT02417532
Recruitment Status : Terminated (PI determined additional subjects would not change outcome)
First Posted : April 15, 2015
Results First Posted : February 17, 2017
Last Update Posted : February 17, 2017
Sponsor:
Collaborator:
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 : 57 participants
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. Completion of Transfer [ Time Frame: 1 day ]
    Completion of transfer from wheelchair or bed to REX device

  2. Completion of REXercise 1 [ Time Frame: 1 day ]
    Bilateral Shoulder Abduction

  3. Completion of REXercise 2 [ Time Frame: 1 day ]
    Lateral Trunk Extension

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


Secondary Outcome Measures :
  1. User Transfer, in First Use [ Time Frame: 1 day ]
    Ability to transfer to Rex in first use of device

  2. Competency of User, in First Use, in Autonomous Control of the Device in <10 Minutes [ Time Frame: 1 Day ]
    Competent ability of user to use device within the first 10 Minutes without assistance

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

  4. Timed up and go Test- Ability to Stand From Chair [ Time Frame: 1 Day ]
    Walk 3 m and turn around and walk back to the chair. (Functional test)



Information from the National Library of Medicine

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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
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

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 ClinicalTrials.gov identifier (NCT number): NCT02417532


Locations
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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
Physiofunction
Moulton, Northamptonshire, United Kingdom, NN37rr
Sponsors and Collaborators
Rex Bionics Plc
Generic Devices Consulting, Inc.
Investigators
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Principal Investigator: Nicholas C Birch, FRCS The Chris Moody Centre

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Rex Bionics Plc
ClinicalTrials.gov Identifier: NCT02417532     History of Changes
Other Study ID Numbers: RXPR-0001
First Posted: April 15, 2015    Key Record Dates
Results First Posted: February 17, 2017
Last Update Posted: February 17, 2017
Last Verified: December 2016
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