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Trial registered on ANZCTR


Registration number
ACTRN12618001546246
Ethics application status
Approved
Date submitted
12/09/2018
Date registered
17/09/2018
Date last updated
17/09/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of feasibility and clinical utility of computer assisted robotic devices for upper limb therapy for patients with cervical level spinal cord injuries
Scientific title
Evaluation of feasibility and clinical utility of computer assisted robotic devices for upper limb therapy for patients with cervical level spinal cord injuries
Secondary ID [1] 296069 0
Nil
Universal Trial Number (UTN)
U1111-1220-3660
Trial acronym
Nil
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
Cervical level spinal cord injury 309626 0
Condition category
Condition code
Injuries and Accidents 308440 308440 0 0
Other injuries and accidents
Physical Medicine / Rehabilitation 308453 308453 0 0
Occupational therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: Use of Tyromotion Diego robotics

Participants are consenting patients with a cervical level spinal cord injury who have been cleared by their consultant for the study, in acute care.
Delivery of the protocol will be done by two occupational therapists and two researchers who have all been trained in the use of the Tyromotion Diego equipment.
Procedure:
1. All patients with SCI are reviewed by OT when first admitted to the ward. At this stage, the OT will assess each patient to determine eligibility. If eligible, written consent for patient to participate to be provided by patient’s spinal rehabilitation consultant.
2. If eligible, the purpose and methodology of the trial will be discussed with the patient. The patient will then be provided with a participant information statement. Patient to provide informed written consent.
3. Patient assessed using the following assessments:
- Canadian Occupational Performance Measure (COPM)
- Spinal Cord Independence Measure (SCIM)
- manual muscle testing of upper limb
- goniometer range of motion (ROM) testing of upper limb
- spasticity testing (Modified Ashworth Scale)
- visual analogue pain scale
- visual analogue fatigue scale
- proprioception assessment
- Tyromotion assessment of muscle strength and ROM.
This will take approximately 2 x 1 hour sessions.
4. The Tyromotion Diego is a bi-lateral sling to support both upper limbs. Patients are seated in their wheelchairs and their arms are strapped in to the slings, and the robotics function removes gravity and allows assisted movement of the upper limbs in a number of directions. The Diego also records accurate ranges of motion at the shoulder and elbow, and the robotics function can be adjusted to provide less assistance as the patient progresses.
5. For the following 4.25 weeks, patient will have upper limb standard therapy and Tyromotion upper limb therapy timetabled. A diary will be kept with patient’s attendance noted, as well as activities participated in, exercises/games completed, functional tasks completed, number of repetitions and resistance settings/assistance provided. Standard upper limb therapy sessions will be scheduled for maximum 2 x 1 hour sessions per week (or up to patient’s tolerance). Sessions will be based on the patient’s functional goals and will be split with 30 minutes of upper limb exercises and 30 minutes application to functional tasks.
- Tyromotion upper limb sessions will be scheduled for 3 x 1 hour sessions per week (1 hour per day in the AM). This will include 10 min set-up, 30 min of exercises with patient facing the computer screen. Games selected will be impairment oriented and games chosen specifically based on pathology. The patient will commence at the easiest level to allow the patient to master the game, then as the patient succeeds at each level, graded upwards in challenge. Exercises will focus on bilateral shoulder/elbow work. Time spent on each game will be recorded. The patient will then engage in 20 minutes of exercises facing away from Diego. This will include a function feeding/reach task which is bilateral task oriented. Time taken to complete tasks will be noted. Exercises will be selected based on the patient’s functional goals.
The intervention will be delivered by an occupational therapist with experience in spinal cord injury management, face to face.
Intervention code [1] 312405 0
Diagnosis / Prognosis
Comparator / control treatment
This study is not controlled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307416 0
Canadian Occupational Performance Measure (COPM) outcome score
Timepoint [1] 307416 0
Pre and post intervention
Primary outcome [2] 307417 0
Spinal Cord Independence Measure (SCIM) score
Timepoint [2] 307417 0
Pre and post intervention
Primary outcome [3] 307418 0
Range of motion of upper limb - measured by the Diego and manually measured by a therapist using a goniometer
Timepoint [3] 307418 0
Pre and post intervention
Secondary outcome [1] 351856 0
Patients’ perceptions and experience of using the device using qualitative interviews

Timepoint [1] 351856 0
Post intervention
Secondary outcome [2] 351858 0
Therapists’ perceptions and experience of using the device using qualitative interviews
Timepoint [2] 351858 0
Post intervention
Secondary outcome [3] 351907 0
Modified Ashworth Scale Score
Timepoint [3] 351907 0
Pre and post intervention
Secondary outcome [4] 351908 0
Visual analogue pain scale score
Timepoint [4] 351908 0
Pre and post intervention
Secondary outcome [5] 351909 0
Visual analogue fatigue scale score
Timepoint [5] 351909 0
Pre and post intervention
Secondary outcome [6] 351910 0
Proprioception assessment conducted manually by the therapist
Timepoint [6] 351910 0
Pre and post Intervention
Secondary outcome [7] 351911 0
Manual muscle testing of upper limb conducted manually by the therapist
Timepoint [7] 351911 0
Pre and post intervention

Eligibility
Key inclusion criteria
1. Patients within the Royal North Shore Hospital Spinal Cord Injury Unit with a new acute complete or incomplete (ASIA impairment scale categories A-D) cervical spinal cord injury.
2. Involvement will be approved by the treating consultant.
3. Participants must provide informed consent.
4. Participant can tolerate sitting up in wheelchair for at least 1.5 hours.
5. Participant is over the age of 18 years old.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patient has a pre-existing spinal cord injury.
2. Spinal injury is lower than cervical level.
3. Consultant does not approve patient’s participation in study. (Aspects that may be considered by the consultant include but are not limited to , no active movement in upper limbs, medically unstable, delirium or acute confused state, shoulder subluxation, severe spasticity or spasms, shoulder and elbow contracture, unable to sit for 1.5 hours, epilepsy, severely visually impaired, poor balance or cerebral ataxia.
4. Participants will be removed from the study if they withdraw consent.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Feasibility pilot study
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
This is a pilot study, with the primary aim of determining the feasibility and operability of the Tyromotion Diego in an acute clinical context. The study will use a convenience sample of patients from the Royal North Shore Hospital Spinal Injury Unit. The sample size selected is an estimation of the number of patients on the ward meeting the eligibility criteria over a 12 month period. Data from this study will provide information to facilitate sample size calculations for future more in-depth studies on this topic.

The data will be analysed using descriptive and comparative statistics using the SPSS statistical package, to determine similarities and differences between patient groups before and after the Tyromotion Diego intervention.

Interview transcripts will be analysed using NVivo 10 software. Transcripts will be read and re-read, then coded line-by-line. Each code will be grouped with similar codes to form themes. Repetition of similar themes within new interviews will indicate that data saturation has been reached.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 11836 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 23973 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 300661 0
Hospital
Name [1] 300661 0
Royal North Shore Hospital
Address [1] 300661 0
St. Leonards, NSW 2065
Country [1] 300661 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Tyromotion
Address
Tyromotion GmbH

Bahnhofgürtel 59
8020 Graz
AUSTRIA
Country
Austria
Secondary sponsor category [1] 300179 0
None
Name [1] 300179 0
Address [1] 300179 0
Country [1] 300179 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301442 0
North Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 301442 0
Kolling Building, Level 13
Royal North Shore Hospital
St Leonards NSW 2065
Ethics committee country [1] 301442 0
Australia
Date submitted for ethics approval [1] 301442 0
24/01/2018
Approval date [1] 301442 0
07/08/2018
Ethics approval number [1] 301442 0
RESP/17/361

Summary
Brief summary
The project aims to evaluate the feasibility and clinical utility of the Tyromotion Diego robotic equipment to assist in the upper limb rehabilitation of people with a cervical spinal cord injury in acute care. A cervical spinal cord injury is catastrophic and causes significant functional limitations. Patients are often very keen to participate in rehabilitation sessions to assist them to undertake functional tasks such as self feeding, grooming or using a mobile phone. A six week intervention protocol involving pre and post outcome measures has been devised, including three sessions per week using the Tyromotion. We will investigate the outcomes achieved during the intervention period and interview patients about their experience of the intervention.
Trial website
None
Trial related presentations / publications
None
Public notes
None

Contacts
Principal investigator
Name 87014 0
A/Prof Lynette Mackenzie
Address 87014 0
Discipline of Occupational Therapy
Faculty of Health Sciences
University of Sydney
Lidcombe,
NSW 2141
Country 87014 0
Australia
Phone 87014 0
+61 422583258
Fax 87014 0
Email 87014 0
Lynette.Mackenzie@sydney.edu.au
Contact person for public queries
Name 87015 0
A/Prof Lynette Mackenzie
Address 87015 0
Discipline of Occupational Therapy
Faculty of Health Sciences
University of Sydney
Lidcombe,
NSW 2141
Country 87015 0
Australia
Phone 87015 0
+61 422583258
Fax 87015 0
Email 87015 0
Lynette.Mackenzie@sydney.edu.au
Contact person for scientific queries
Name 87016 0
A/Prof Lynette Mackenzie
Address 87016 0
Discipline of Occupational Therapy
Faculty of Health Sciences
University of Sydney
Lidcombe,
NSW 2141
Country 87016 0
Australia
Phone 87016 0
+61 422583258
Fax 87016 0
Email 87016 0
Lynette.Mackenzie@sydney.edu.au

No data has been provided for results reporting
Summary results
Not applicable