None listed
Conditions
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.
Interventions
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
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.
Sponsors
University of Auckland
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
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
Outcome results
None listed