Our objective is to design and evaluate proof-of-concept of the WalkWell Gait reTrainer, an affordable, user-friendly continuous gait feedback system, complete with remote patient monitoring capabilities to support clinical care. We hypothesize that…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Qualitative data from participants and physiotherapists on how they use the
WalkWell Gait reTrainer (i.e. user experience). We will also explore the
participant*s ability to consistently alter their FPA in response to the
feedback given by the WallWell Gait reTrainer, and their ability to maintain
their target FPA over a short period of one week (i.e. feasibility).
Secondary outcome
Quantify correlations among the data collected and evaluate the associations
between biomechanical parameters and other variables including participant
demographics.
Background summary
Osteoarthritis (OA) is a leading cause of disability and source of societal
cost. OA is a complex, chronic disease predominantly caused by increased
mechanical load on joint cartilage. Gait retraining has been shown to modify
mechanical load in knee OA patients, with real-time feedback to assist patients
with optimizing gait patterns. Altering the foot progression angle (FPA), i.e.,
toe in or toe out, is relatively easy and reduces knee loading. Gait feedback
typically requires practice sessions in a lab using expensive equipment.
However, continuous feedback in one*s natural environment could yield more
effective and sustainable gait adaptations. With remote monitoring, clinicians
can monitor patient performance between treatment sessions.
Study objective
Our objective is to design and evaluate proof-of-concept of the WalkWell Gait
reTrainer, an affordable, user-friendly continuous gait feedback system,
complete with remote patient monitoring capabilities to support clinical care.
We hypothesize that this system is usable in a community and home setting, and
permits clinicians to remotely monitor progress, to yield efficient and
effective gait adaptations. The data collected in this study will be pivotal in
planning future large-scale intervention trials to assess the system's
efficacy.
Study design
We will evaluate the feasibility and user experience of the WalkWell Gait
reTrainer to provide feedback on the FPA in healthy volunteers; and a 1-week
follow-up to investigate the feasibility and user experience of remote
monitoring.
Study burden and risks
Participants will attend a visit to the lab involving biomechanical assessment,
performing walking with different FPAs. Participants will rate the comfort of
each walking pattern. Total time for data collection will be approximately 2-3
hours in the lab. Afterwards, during a 1-week follow-up period, we will
evaluate their experience with using the device at home during daily walks,
using questionnaires and interviews.
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
Healthy controls:
over 45 years old
able to walk for at least 15 to 30 minutes for 3 to 7 days per week without any
walking aids
Physiotherapists:
work for at least two years as a physiotherapist in primary care
provide treatment for patients with knee complaints two or more times per week
have affinity with technical developments in physiotherapy care
Exclusion criteria
Healthy controls:
Activity-related knee pain and morning knee stiffness or stiffness of 30
minutes or more.
Traumatic knee injury or surgery in the past year.
Any neurological, rheumatological, or metabolic disorders affecting mobility.
Other diagnosed causes of knee symptoms (e.g. tendonopathy).
Musculoskeletal conditions affecting the ankles, hips, pelvis or lumbar spine.
Body mass index > 35 kg/m2.
Cognitive impairments.
Unable to communicate in either Dutch or English
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL87301.078.24 |