Safety and Feasibility Evaluation of Robot Assisted Physiotherapy Exercises With REX

NCT02417532 | Completed Results

• 1 other identifier: RXPR-0001
• Study Type: interventional
• Target: 56
• Locations: 3 countries
• Sites: 6

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.

Conditions

Spinal Cord Injury

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Participant Satisfaction Questionnaire

  1 Day

• Timed up and go Test- Ability to Stand From Chair

  1 Day

Study Arms (1)

Rehabilitation using REX

EXPERIMENTAL

Exercises using Rex mobility assist device

Device: Rehabilitation using REX

Interventions

Rehabilitation using REX DEVICE

Exercises of wheelchair dependent subjects using REX

Rehabilitation using REX

Eligibility Criteria

• Age: 10 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Withdrawal or refusal to sign informed consent
• Any other contraindication based on physician discretion
• Known allergy (skin contact) to materials used in Rex

Sponsors & Collaborators

• Rex Bionics Plc: lead
• Generic Devices Consulting, Inc.: collaborator

Study Sites (6)

Austin Health

Heidelberg, Victoria, 3084, Australia

Location

Rehabilitation Innovation Centre at AUT University

Auckland, 1010, New Zealand

Location

Canterbury District Health Board, Burwood Hospital

Christchurch, 4708, New Zealand

Location

East Kent Hospitals University Foundation Trust

Canterbury, Kent, CT1 3NG, United Kingdom

Location

Royal National Orthopaedic Hospital NHS Trust

Stanmore, Middlesex, WD6 4QY, United Kingdom

Location

Physiofunction

Moulton, Northamptonshire, NN37rr, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 28629390 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Limitations and Caveats

Patients enrolled under at different times in the recruitment process had differing lengths of follow-up as reflected in the final study report.

Results Point of Contact

• Title: Nick Birch
• Organization: The Chris Moody Centre

nickbirch@doctors.org.uk

+44 1604 215440

Study Officials

• Nicholas C Birch, FRCS

  The Chris Moody Centre

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2015
• First Posted: April 15, 2015
• Study Start: May 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: July 23, 2019
• Results First Posted: February 17, 2017

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); GB (3); NZ (2)