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

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.

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injury
• Intervention / Treatment: Device: Rehabilitation using REX

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.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Heidelberg, Victoria, Australia, 3084
      • Austin Health
• New Zealand
  • Auckland, New Zealand, 1010
    • Rehabilitation Innovation Centre at AUT University
  • Christchurch, New Zealand, 4708
    • Canterbury District Health Board, Burwood Hospital
• United Kingdom
  • Kent
    • Canterbury, Kent, United Kingdom, CT1 3NG
      • East Kent Hospitals University Foundation Trust
  • Middlesex
    • Stanmore, Middlesex, United Kingdom, WD6 4QY
      • Royal National Orthopaedic Hospital NHS Trust
  • Northamptonshire
    • Moulton, Northamptonshire, United Kingdom, NN37rr
      • Physiofunction

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 90 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Rehabilitation using REX; Exercises using Rex mobility assist device	Device: Rehabilitation using REX; Exercises of wheelchair dependent subjects using REX

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ability to Transfer	Completion of transfer with supervision or 1 assistant from wheelchair or bed into REX	1 day
Adverse Events	absence of unexpected serious adverse events	1 day
Transfer Time	Time it took for participant to transfer into the Rex with or without supervision.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant Satisfaction Questionnaire	overall user satisfaction with the device	1 Day
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

Collaborators and Investigators

• Sponsor: Rex Bionics Plc
• Collaborators: Generic Devices Consulting, Inc.
• Investigators: Principal Investigator: Nicholas C Birch, FRCS, The Chris Moody Centre

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (ACTUAL): December 1, 2016
• Study Completion (ACTUAL): December 1, 2016

Study Registration Dates

• First Submitted: April 11, 2015
• First Submitted That Met QC Criteria: April 14, 2015
• First Posted (ESTIMATE): April 15, 2015

Study Record Updates

• Last Update Posted (ACTUAL): July 23, 2019
• Last Update Submitted That Met QC Criteria: July 18, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: RXPR-0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO