Back to resultsSafety and Feasibility Evaluation of Robot Assisted Physiotherapy Exercises With REX (RAPPER II)
Primary Purpose
Spinal Cord Injury
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Rehabilitation using REX
Sponsored by
About this trial
This is an interventional supportive care trial for Spinal Cord Injury
Eligibility 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
Sites / Locations
- Austin Health
- Rehabilitation Innovation Centre at AUT University
- Canterbury District Health Board, Burwood Hospital
- East Kent Hospitals University Foundation Trust
- Royal National Orthopaedic Hospital NHS Trust
- Physiofunction
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Rehabilitation using REX
Arm Description
Exercises using Rex mobility assist device
Outcomes
Primary Outcome Measures
Ability to Transfer
Completion of transfer with supervision or 1 assistant from wheelchair or bed into REX
Adverse Events
absence of unexpected serious adverse events
Transfer Time
Time it took for participant to transfer into the Rex with or without supervision.
Secondary Outcome Measures
Participant Satisfaction Questionnaire
overall user satisfaction with the device
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)
Full Information
NCT ID
NCT02417532
First Posted
April 11, 2015
Last Updated
July 18, 2019
Sponsor
Rex Bionics Plc
Collaborators
Generic Devices Consulting, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02417532
Brief Title
Safety and Feasibility Evaluation of Robot Assisted Physiotherapy Exercises With REX
Acronym
RAPPER II
Official Title
Safety and Feasibility Evaluation of Robot Assisted Physiotherapy Exercises With REX
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rex Bionics Plc
Collaborators
Generic Devices Consulting, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rehabilitation using REX
Arm Type
Experimental
Arm Description
Exercises using Rex mobility assist device
Intervention Type
Device
Intervention Name(s)
Rehabilitation using REX
Intervention Description
Exercises of wheelchair dependent subjects using REX
Primary Outcome Measure Information:
Title
Ability to Transfer
Description
Completion of transfer with supervision or 1 assistant from wheelchair or bed into REX
Time Frame
1 day
Title
Adverse Events
Description
absence of unexpected serious adverse events
Time Frame
1 day
Title
Transfer Time
Description
Time it took for participant to transfer into the Rex with or without supervision.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Participant Satisfaction Questionnaire
Description
overall user satisfaction with the device
Time Frame
1 Day
Title
Timed up and go Test- Ability to Stand From Chair
Description
The number of seconds required to walk 3 m and turn around and walk back to the chair. (Functional test)
Time Frame
1 Day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicholas C Birch, FRCS
Organizational Affiliation
The Chris Moody Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Austin Health
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Rehabilitation Innovation Centre at AUT University
City
Auckland
ZIP/Postal Code
1010
Country
New Zealand
Facility Name
Canterbury District Health Board, Burwood Hospital
City
Christchurch
ZIP/Postal Code
4708
Country
New Zealand
Facility Name
East Kent Hospitals University Foundation Trust
City
Canterbury
State/Province
Kent
ZIP/Postal Code
CT1 3NG
Country
United Kingdom
Facility Name
Royal National Orthopaedic Hospital NHS Trust
City
Stanmore
State/Province
Middlesex
ZIP/Postal Code
WD6 4QY
Country
United Kingdom
Facility Name
Physiofunction
City
Moulton
State/Province
Northamptonshire
ZIP/Postal Code
NN37rr
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28629390
Citation
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.
Results Reference
derived
Learn more about this trial
Safety and Feasibility Evaluation of Robot Assisted Physiotherapy Exercises With REX
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