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| Name | Class |
|---|---|
| Dynamic Metrics Ltd | INDUSTRY |
| University of East Anglia | OTHER |
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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.
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. All volunteers in the intervention group will be provided with a copy of their report. Protocol for SoC group SoC volunteers receive a GaitSmart test at their first appointment but are not given their report. Questionnaires to record Volunteer reported outcome measures (PROMS) include: Oxford hip score (OHS) or Oxford knee score (OKS) plus the Euroqol questionnaire (EQ5D-5D) are completed. SoC volunteers return at week 15 for a second test but are not given their report. Questionnaires to record Volunteer reported outcome measures (PROMS) include: Oxford hip score (OHS) or Oxford knee score (OKS) plus the Euroqol questionnaire (EQ5D-5D) are completed. Protocol for GaitSmart intervention group GaitSmart intervention group have the procedure explained to them at the first appointment. All exercises have the volunteer standing or sitting and are chosen from exercises already provided by the NHS. Each volunteer will get a subset of these. The nurse will ensure volunteers can perform the exercises before leaving the session. GaitSmart test performed at weeks 6, 9, 12 and 15. The report is provided plus six personalised exercises. The nurse will check they are able to perform the tests at each visit. Those not suitable will be struck off the list. Questionnaires to record Volunteer reported outcome measures (PROMS) will be completed at weeks 6 and 15.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise | Active Comparator | Personalised exercise programme is provided to the exercise group. |
|
| No Intervention | No Intervention | This group of patients will receive no intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Other | A set of exercises are provided to each patient. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion:
Exclusion:
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| Name | Affiliation | Role |
|---|---|---|
| Iain McNamara, MD | Clinical Research and Trials Unit (Norfolk and Norwich University Hospital, UK) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Norfolk and Norwich University Hospital | Norwich | Norfolk | NR4 7UY | United Kingdom |
Anonymised data will be shared by all partners. Only Norfolk and Norwich University Hospital will hold full patient data.
0 to 28 months, which is 12 months after project completion.
Access to the research dataset will be permitted via application to the CI's and sponsor.
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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