MAP REHAB
Research type
Research Study
Full title
Modelling and Artificial intelligence using sensor data to Personalise REHABilitation following joint replacement
IRAS ID
277658
Contact name
Iain Mcnamara
Contact email
Sponsor organisation
Norfolk & Norwich University Hospitals NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 1 months, 8 days
Research summary
Research Summary
In the UK, success of total hip replacement (THR) or total knee replacement (TKR) replacements are measured using questionnaires. Patient Reported Outcome Measures (PROMs) which show an improvement of 96.5% for THR and 93.6% for TKR. However, only 67.5% of THR patients and 58.9% of TKR patients reported an improvement in Quality of Life (QoL) (EQ-VAS) at 6 months after surgery. This latter value is broadly similar to published data that shows approximately 50% of hip and knee patients have some gait abnormalities one year post operatively, associated with poorer reported quality of life.
People adapt their gait to avoid pain in the arthritic joint thereby creating abnormalities in their gait over time. Once the joint pain is relieved by surgery, patients need retraining to walk correctly and strengthen weakened muscles. Because patients are generally unaware of how their walking pattern has adapted over time, many continue to load joints and use muscles incorrectly. This can lead to falls, reduced activity, Osteoarthritis or further joint replacement surgery.
This project aims to improve patients’ gait after hospital discharge through objective analysis and recommended bespoke exercises with the expectation this will improve walking and movement and through this improvement in QoL as well as future reductions in musculoskeletal and other related health conditions.
Studies using GaitSmart on older people who have fallen have already confirmed that an assessment and intervention programme can help patients improve their gait and QoL.
The study will produce data to objectively assess physical outcomes in THR and TKR patients post-operatively. GaitSmart provides a standardized digital gait analysis to enable better rehabilitation and hip and knee functionality and aims to optimize the impact of the initial surgery in the long-term. The study aims to assess the effectiveness of the intervention on gait, movement and QoL (on five dimensions and one overall score) and will also compare the resource costs of using the new care pathway against the existing the existing costs in the standard of care (SoC) pathway. The clinical efficacy of the new care pathway will be determined by comparing patient data up to 15 weeks post-operatively between the control and intervention groups. An economic evaluation will be carried out concurrently with the trial to determine the cost-effectiveness of GaitSmart versus current SoC and will be compared to current thresholds for adoption used by NICE.
Currently no objective assessment is carried out either pre- or post-operatively. In addition to improving individual patient care, comparisons between types of THR and TKR procedures, implants, healthcare providers, care protocols etc. could be made in the future using GaitSmart.Lay summary of study results
This pilot study has shown that the GaitSmart intervention programme can be delivered in an outpatient department by a health care assistant. The findings suggest that the intervention programme has a greater impact on the patient’s gait, compared to SoC, whilst patient reported outcomes varied between groups. This presents a feasible method of offering a rehabilitation intervention in an outpatient setting to improve patient outcomes. This pilot demonstrated positive results, with no amendments proposed to the protocol, for progression to future trials intended to extend site coverage.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
20/EE/0086
Date of REC Opinion
14 May 2020
REC opinion
Further Information Favourable Opinion