Modelling and AI Using Sensor Data to Personalise REHABilitation Following Joint Replacement

NCT04289025 | Completed

• 1 other identifier: Dig Health01
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to determine a volunteer's gait objectively after surgery, when signed off from the consultant and physiotherapist. This will identify any gait deficiencies using simple traffic light coding, using GaitSmart, a CE Marked Class 1M Medical Device. Volunteers chosen for the intervention programme, a set of exercises to improve gait deficiencies identified in the report. All the exercises will be standard one already used within the NHS. The objectives are to compare the outcomes from the intervention group with the Standard of Care group, in terms of gait and PROMS and from this determine the clinical and economic benefits of the intervention.

Conditions

Arthroplasty Complications

Keywords

Arthroplasty; Replacement Rehabilitation

Outcome Measures

Primary Outcomes (3)

• Objective change in gait kinematics

  Change in a patient's gait measured objectively using Gaitsmart

  15 weeks post op

• Subjective change in gait

  Change in a patient's Oxford hip or knee score

  15 weeks post op

• Quality of life changes

  Change in a patient's Quality of Life score (EQ5D)

  15 weeks post op

Study Arms (2)

Exercise

ACTIVE COMPARATOR

Personalised exercise programme is provided to the exercise group.

Other: Exercise

No Intervention

NO INTERVENTION

This group of patients will receive no intervention.

Interventions

Exercise OTHER

A set of exercises are provided to each patient.

Exercise

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject must provide written informed consent.
• Subject is scheduled for primary Total Knee replacement / Total Hip replacement within the next 30 days.
• Subject is considered skeletally mature.
• Subject is willing, able, and plans to perform the activities associated with the study.
• Unilateral or bilateral hip or knee replacement volunteers free of moderate to severe pain in the contralateral limb.
• Signed off at 6 weeks by physiotherapist.

You may not qualify if:

• Will not be a resident living within the catchment area for Norfolk \& Norwich University hospital for at least 6 months post-surgery.
• Undertaking the surgery as a private patient.
• Patients who, in the opinion of the clinical staff, do not have capacity to consent.
• Patients who are pregnant.
• Unable to understand written and spoken English.
• Patient who is currently enrolled in another interventional trial involving surgery, exercise or rehabilitation.
• Any neurological condition that affects movement.

Sponsors & Collaborators

• Norfolk and Norwich University Hospitals NHS Foundation Trust: lead
• Dynamic Metrics Ltd: collaborator
• University of East Anglia: collaborator

Study Sites (1)

Norfolk and Norwich University Hospital

Norwich, Norfolk, NR4 7UY, United Kingdom

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Iain McNamara, MD

  Clinical Research and Trials Unit (Norfolk and Norwich University Hospital, UK)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2020
• First Posted: February 28, 2020
• Study Start: September 23, 2020
• Primary Completion: December 9, 2021
• Study Completion: February 24, 2022
• Last Updated: April 4, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: 0 to 28 months, which is 12 months after project completion.
• Access Criteria: Access to the research dataset will be permitted via application to the CI's and sponsor.

Locations

GB (1)