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Completed

NCT Number: NCT02417532

Safety and Feasibility Evaluation of Robot Assisted Physiotherapy Exercises With REX

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.

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Key information

Age range

10 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Austin Health, Heidelberg, Victoria, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rehabilitation using REX

Device

Exercises of wheelchair dependent subjects using REX

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Rex Bionics Plc

Industry

Collaborators

  • Generic Devices Consulting, Inc.

Registry information

Acronym: RAPPER II

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 15, 2015
Registry last updated
Jul 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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