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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02417532




Registration number
NCT02417532
Ethics application status
Date submitted
11/04/2015
Date registered
15/04/2015
Date last updated
23/07/2019

Titles & IDs
Public title
Safety and Feasibility Evaluation of Robot Assisted Physiotherapy Exercises With REX
Scientific title
Safety and Feasibility Evaluation of Robot Assisted Physiotherapy Exercises With REX
Secondary ID [1] 0 0
RXPR-0001
Universal Trial Number (UTN)
Trial acronym
RAPPER II
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spinal Cord Injury 0 0
Condition category
Condition code
Injuries and Accidents 0 0 0 0
Fractures
Injuries and Accidents 0 0 0 0
Other injuries and accidents
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Rehabilitation using REX

Experimental: Rehabilitation using REX - Exercises using Rex mobility assist device


Treatment: Devices: Rehabilitation using REX
Exercises of wheelchair dependent subjects using REX
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Ability to Transfer
Timepoint [1] 0 0
1 day
Primary outcome [2] 0 0
Adverse Events
Timepoint [2] 0 0
1 day
Primary outcome [3] 0 0
Transfer Time
Timepoint [3] 0 0
1 day
Secondary outcome [1] 0 0
Participant Satisfaction Questionnaire
Timepoint [1] 0 0
1 Day
Secondary outcome [2] 0 0
Timed up and go Test- Ability to Stand From Chair
Timepoint [2] 0 0
1 Day

Eligibility
Key inclusion 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
Minimum age
10 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Other
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2016
Sample size
Target
Accrual to date
Final
56
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Austin Health - Heidelberg
Recruitment postcode(s) [1] 0 0
3084 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Christchurch
Country [3] 0 0
United Kingdom
State/province [3] 0 0
Kent
Country [4] 0 0
United Kingdom
State/province [4] 0 0
Middlesex
Country [5] 0 0
United Kingdom
State/province [5] 0 0
Northamptonshire

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Rex Bionics Plc
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Generic Devices Consulting, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT02417532
Trial related presentations / 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.
Public notes

Contacts
Principal investigator
Name 0 0
Nicholas C Birch, FRCS
Address 0 0
The Chris Moody Centre
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02417532