Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001178235
Ethics application status
Approved
Date submitted
12/07/2018
Date registered
16/07/2018
Date last updated
16/10/2019
Date data sharing statement initially provided
16/10/2019
Date results information initially provided
16/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
RELIEF: Feasibility of the Re-Link Trainer for walking rehabilitation after stroke
Scientific title
Clinical feasibility, usability, and acceptance of the Re-Link Gait Trainer in sub-acute stroke rehabilitation
Secondary ID [1] 295542 0
Nil known
Universal Trial Number (UTN)
U1111-1217-3897
Trial acronym
RELIEF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 308811 0
Condition category
Condition code
Stroke 307741 307741 0 0
Ischaemic
Stroke 307742 307742 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of the Re-Link Trainer (RLT) is to improve patient rehabilitation outcomes by using the device to improving gait recovery after stroke. The device consists of a 4-bar linkage design that attaches to the patient’s weak lower limb via a footplate. The linkage system can be fitted to either side of the device, accommodating left or right side paresis. The paretic limb is guided through a normal gait trajectory when using the device as part of rehabilitation. The Re-Link Trainer is a passive mechanical device (non-motorised) that inherently encourages patient engagement since the paretic leg will hinder movement of the frame if it does not contribute to walking.

Forward progression of the Re-Link Trainer is generated by the patient, or by a single therapist, pushing the walking frame as they would using a standard walking frame. As they walk holding the frame, the linkage system mounted on the frame lifts the patient’s foot to provide ground clearance and achieve a step with the paretic limb. The footplate rotates on the linkage allowing the patients ankle to move through a normal trajectory and range of motion. The footplate provides support to the foot during the swing-phase, minimizing foot drop and risk of tripping. An integrated body-weight support cradle allows for partial or full body-weight support, and can be removed as the patient progresses.

Participants and therapists will be invited to use the Re-Link Trainer as part of walking therapy during inpatient rehabilitation after stroke. The amount of use will be recorded and feedback from participants and therapists sought. Participants and therapists will be free to choose whether they use the Re-Link Trainer, and for how long, in each therapy session. Therapists will record how long the Trainer is used for during over-ground walking in the inpatient rehabilitation ward environment. Use of the Trainer is at participant and therapist discretion.
Intervention code [1] 301843 0
Rehabilitation
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306726 0
Safety, measured as the number of adverse events and reactions experienced by participants that are related to use of the Re-Link Trainer. Falling is a foreseeable adverse reaction, and the risk of falling is mitigated by having an in-built weight support system, so that the participant will be prevented from falling to the floor while using the Trainer.

More generally, an adverse event is any untoward medical occurrence in a participant, including occurrences which are not necessarily caused by or related to study procedures
Adverse events may include
a. Infections
b. Recurrent stroke
c. Medical instability
All adverse events will be recorded by the site and study coordinator

An adverse reaction is an untoward and unintended response in a participant that is related to study procedures
The main foreseeable adverse reaction is a fall while using the Trainer. In the event of a fall the physiotherapist, in consultation with the research team (if needed), will determine if the fall or other adverse reaction was due to the Re-Link Trainer. All adverse reactions will be recorded by the site coordinator in both the patient’s clinical notes and their de-identified study records, and reported to the patient’s clinical team. If more than 10% of the sample (>2 participants) records an adverse reaction/fall during use of the Re-Link Trainer then the study will be stopped.
Timepoint [1] 306726 0
Discharge from inpatient rehabilitation.
Secondary outcome [1] 349358 0
Usability, measured as the number and duration of therapy sessions completed with and without the Re-Link trainer.
Timepoint [1] 349358 0
Discharge from inpatient rehabilitation.
Secondary outcome [2] 349359 0
Acceptance, measured with Likert scales and interviews conducted with participants and therapists by independent assessors.
Timepoint [2] 349359 0
Discharge from inpatient rehabilitation.
Secondary outcome [3] 349360 0
Walking ability, measured with the Functional Ambulation Classifications.
Timepoint [3] 349360 0
2, 4, 8 and 12 weeks post-stroke.
Secondary outcome [4] 349361 0
Walking velocity, measured with the 10 metre walk test.
Timepoint [4] 349361 0
2, 4, 8 and 12 weeks post-stroke.
Secondary outcome [5] 349362 0
Walking endurance, measured with the six minute walk test.
Timepoint [5] 349362 0
12 weeks post-stroke.
Secondary outcome [6] 349363 0
Walking quality, measured with a Gait Mat to obtain kinematic measures of walking cadence and symmetry.
Timepoint [6] 349363 0
2, 4, 8 and 12 weeks post-stroke.
Secondary outcome [7] 349364 0
Stroke related quality of life, measured with the Stroke Impact Scale.
Timepoint [7] 349364 0
12 weeks post-stroke.

Eligibility
Key inclusion criteria
i. First time ischaemic stroke or intracerebral haemorrhage within the previous 4 weeks resulting in hemiplegia
ii. At least 18 years old
iii. May have had thrombolysis or thrombectomy
iv. Gait impairment (FAC score < 4)
v. Must be able to stand with assistance of no more than two people
vi. Undergoing gait rehabilitation
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i. Unable to follow a one-step command, precluding instruction on how to use the Re-Link Trainer
ii. Cognitive or communication impairment that would preclude informed consent and completion of written or verbal questionnaire
iii. Previous stroke
iv. Cerebellar stroke
v. Pre-stroke FAC score < 4 (not independent).
vi. Requires hoist transfers
vii. Palliative care

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)
Not applicable.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
This is a feasibility study.
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
No statistical comparisons.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2018
Actual
7/11/2018
Date of last participant enrolment
Anticipated
Actual
8/07/2019
Date of last data collection
Anticipated
Actual
11/10/2019
Sample size
Target
25
Accrual to date
Final
12
Recruitment outside Australia
Country [1] 10642 0
New Zealand
State/province [1] 10642 0
Auckland

Funding & Sponsors
Funding source category [1] 300119 0
Government body
Name [1] 300119 0
Health Research Council of New Zealand
Country [1] 300119 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Private Bag 92019
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 299519 0
None
Name [1] 299519 0
Address [1] 299519 0
Country [1] 299519 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300959 0
Health and Disability Ethics Committee
Ethics committee address [1] 300959 0
Postal address:
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140

Street address:
133 Molesworth Street
Thorndon
Wellington 6011
Ethics committee country [1] 300959 0
New Zealand
Date submitted for ethics approval [1] 300959 0
23/07/2018
Approval date [1] 300959 0
25/09/2018
Ethics approval number [1] 300959 0
18/STH/162

Summary
Brief summary
The most common rehabilitation goal after stroke is to be able to walk again. However, of those who are initially non-ambulatory only 60-70% recover the ability to walk independently by 6 months, and many will retain inefficient hemiparetic gait patterns (slow, asymmetrical, and unstable gait). These altered walking patterns make return to full community engagement and safe ambulation considerably difficult. Electromechanical gait therapy at the acute and subacute stage has been shown to improve the odds of non-ambulatory patients becoming independent walkers (OR 2.39). Additionally, robotic devices that involve kinematic constraint of the paretic limb, while still requiring active patient involvement may produce superior rehabilitation outcomes compared to traditional methods of gait rehabilitation. Our research group have developed the first over-ground device which constrains a non-ambulatory acute stroke patient’s limb into a normalized trajectory during gait training.

The aim of the Re-Link Trainer is to improve patient rehabilitation outcomes by using the device to facilitate a level of gait recovery that is superior to presently achievable recovery through conventional therapeutic approaches. The novel hypothesis is based on the idea that if a patient’s walking pattern for the paretic limb is constrained to a physiologically normal trajectory then neural reorganisation early after a stroke would result in the development of a more normal gait pattern.

This research will inform the design of a larger randomised controlled trial of the Re-Link Trainer. In turn, this larger study could help to improve health outcomes for the 8,000+ New Zealanders who experience stroke each year, by improving their recovery of independent walking. Demonstrating the feasibility of this economically viable technology has the potential to reduce inequalities in health-related outcomes, by allowing equitable deployment across all demographics, ethnicities, and socio-economic groups. The portability and simplicity of the trainer enables community deployment in rural areas. The present study is an important first step, to evaluate and improve the Trainer where needed, before committing to an RCT of its therapeutic effects.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 85418 0
Dr Andrew McDaid
Address 85418 0
Department of Mechanical Engineering
University of Auckland
Private Bag 92019
Auckland 1142
Country 85418 0
New Zealand
Phone 85418 0
+6499231898
Fax 85418 0
Email 85418 0
[email protected]
Contact person for public queries
Name 85419 0
Dr Andrew McDaid
Address 85419 0
Department of Mechanical Engineering
University of Auckland
Private Bag 92019
Auckland 1142
Country 85419 0
New Zealand
Phone 85419 0
+6499231898
Fax 85419 0
Email 85419 0
[email protected]
Contact person for scientific queries
Name 85420 0
Dr Andrew McDaid
Address 85420 0
Department of Mechanical Engineering
University of Auckland
Private Bag 92019
Auckland 1142
Country 85420 0
New Zealand
Phone 85420 0
+6499231898
Fax 85420 0
Email 85420 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is a small pilot study.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Basic resultsNo 375590-(Uploaded-11-10-2019-14-48-46)-Basic results summary.docx
Plain language summaryNo This observational feasibility study achieved its ... [More Details]

Documents added automatically
No additional documents have been identified.