Through Knee Amputation Clinical Trial
— COSTAAOfficial title:
Comparing OutcomeS of Through Knee and Above Knee Amputation (COSTAA)
| Verified date | July 2022 |
| Source | Hull University Teaching Hospitals NHS Trust |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
Major lower limb amputation is a life changing surgical procedure to treat complications of diabetes mellitus and peripheral vascular disease. The level of function after amputation is dependent on pre-morbid levels of activity, age, co-morbidities and the level of amputation. The level of amputation performed is determined by level of disease and surgical assessment. Below knee amputation provides the best functional outcomes due to the benefits of keeping the knee intact. When a below knee amputation is not possible, routine practice is to perform an above knee amputation. Greater challenges for rehabilitation present at this level due to the shorter lever. Amputation through the knee is less commonly performed despite its reported benefits which include a long mechanical lever arm, an endbearing stump and greater muscle control. A recent systematic review recommends further comparison of through knee and above knee amputation. The recommended areas of research are gait biomechanics and quality of life for these patient groups. Therefore, the aim of this research is to compare and contrast the long-term functional mobility and quality of life outcomes of limb wearing through knee and above knee amputees. The study will be split into two workstreams, the first focusing on functional outcomes and the second focusing on quality of life using semi-structured interviews.
| Status | Active, not recruiting |
| Enrollment | 40 |
| Est. completion date | October 31, 2022 |
| Est. primary completion date | April 30, 2022 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Community dwelling adults aged 18 or over. - People who have had either a through-knee or above-knee amputation. - Unilateral amputees. - English speaking and cognitively be able to follow instructions and fill out questionnaires independently. Exclusion Criteria: - People are unable to provide an informed consent. - People who have a below-knee amputation. - Unable to transfer with assistance of one. - Unable to walk more than 5 metres (ambulatory section workstream 1 only). - Individuals will be excluded from workstream 2 if they report another health condition with greater impact on their quality of life than their amputation. |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Hull University Teaching Hospitals NHS Trust | Hull | East Riding Of Yorkshire |
| Lead Sponsor | Collaborator |
|---|---|
| Hull University Teaching Hospitals NHS Trust | University of Hull |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The primary outcomes measure for workstream 1 is walking speed. | Walking speed will be determined as distance divided by time in seconds and will be calculated during timed-up-and-go test, L-test, two-minute walk test (2MWT) and six-minute walk test (6MWT). The results will be presented as metres per second | Measures taken at baseline visit, data reported through study completion, an average of 1 year | |
| Primary | The primary outcome measure for workstream 2 is an in-depth analysis and comparison of quality of life. | The analysis of semi-structured interviews and focus groups using a self designed topic guide with questions relating to quality of life. | Through study completion, an average of 1 year | |
| Secondary | The secondary outcome measures for workstream 1 include time taken. | Time taken will be calculated as the time in seconds calculated during timed-up-and-go test and L-test. | Measures taken at baseline visit, data reported through study completion, an average of 1 year | |
| Secondary | The secondary outcome measures for workstream 1 include distance reached. | Distance reached will be calculated as the distance reached in centimetres calculated during the functional reach test, and the sit-and-reach test. | Measures taken at baseline visit, data reported through study completion, an average of 1 year | |
| Secondary | The secondary outcome measures for workstream 1 include distance walked. [ | Distance walked will be calculated as the distance in metres calculated during the 2MWT and 6MWT. | Measures taken at baseline visit, data reported through study completion, an average of 1 year | |
| Secondary | The secondary outcome measures for workstream 1 include step count. | Step count will be calculated as the number of steps taken during timed-up-and-go test, L-test, 2MWT and 6MWT. | Measures taken at baseline visit, data reported through study completion, an average of 1 year | |
| Secondary | The secondary outcome measures for workstream 1 include predicted 6MWT score. | Predicted 6MWT score will be calculated as the distance walked in the 2MWT multiplied by 3. | Measures taken at baseline visit, data reported through study completion, an average of 1 year | |
| Secondary | The secondary outcome measures for workstream 1 include time taken to stand from sitting. | The time taken to stand from sitting will be calculated as the time in seconds taken from the participant moving from a seated to standing position. This will be calculated during the Timed-Up-and-Go test and the L-test. | Measures taken at baseline visit, data reported through study completion, an average of 1 year | |
| Secondary | The secondary outcome measures for workstream 1 include time taken to sit from standing. | The time taken to sit from standing will be calculated as the time in seconds taken from the participant moving from a standing to seated position. This will be calculated during the Timed-Up-and-Go test and the L-test. | Measures taken at baseline visit, data reported through study completion, an average of 1 year | |
| Secondary | The secondary outcome measures for workstream 1 include walking time. | The walking time will be calculated as the time in seconds spent walking to and from the chair. This will be calculated during the Timed-Up-and-Go test and the L-test. | Measures taken at baseline visit, data reported through study completion, an average of 1 year | |
| Secondary | The secondary outcome measures for workstream 1 include functional balance. | Functional balance will be calculated as the overall score from their observed performance across 14 activities when completing the Berg Balance scale. | Measures taken at baseline visit, data reported through study completion, an average of 1 year | |
| Secondary | The secondary outcome measures for workstream 1 include function during sitting. | Function during sitting will be calculated as the overall score from their observed performance across 14 activities when completing the function in sitting test. | Measures taken at baseline visit, data reported through study completion, an average of 1 year | |
| Secondary | The secondary outcome measures for workstream 1 include step length and height. | Step length and height will be observed and recorded as part of the Tinetti assessment. | Measures taken at baseline visit, data reported through study completion, an average of 1 year | |
| Secondary | The secondary outcome measures for workstream 1 include step symmetry. | Step symmetry will be observed and recorded as part of the Tinetti assessment. | Measures taken at baseline visit, data reported through study completion, an average of 1 year | |
| Secondary | The secondary outcome measures for workstream 1 include falls risk using the Tinetti assessment. | Falls risk will be calculated as the overall score from their observed performance out of 28 when completing the Tinetti assessment. | Measures taken at baseline visit, data reported through study completion, an average of 1 year | |
| Secondary | The secondary outcome measures for workstream 1 include recording of confidence levels using the Activity Balance Confidence (ABC-UK) questionnaire. | Confidence levels will be calculated using the Activity-Balance Confidence (ABC-UK) questionnaire.
Items are rated on a scale 0-100, 0 represents no confidence and 100 represents complete confidence when performing activities. |
Measures taken at baseline visit, data reported through study completion, an average of 1 year | |
| Secondary | The secondary outcome measures for workstream 1 include confidence levels using the Locomotor-Capabilities Index-5 (LCI-5) questionnaire. | Confidence levels will be calculated using the Locomotor-Capabilities Index-5 (LCI-5) questionnaire. Items are scored on a 4 point scale ranging from 0 = not able to accomplish activity alone 3= being able to accomplish the activity alone. | Measures taken at baseline visit, data reported through study completion, an average of 1 year | |
| Secondary | The secondary outcome measures for workstream 1 include confidence levels using the Short Form Survey Instrument (SF36) | Confidence levels will be calculated using the Short Form Survey Instrument (SF36). Items are scored using Likert scale and yes/no options. Scales are standardised with a scoring algorithm to obtain a score ranging from 0-100. High scores indicate better health status. | Measures taken at baseline visit, data reported through study completion, an average of 1 year | |
| Secondary | The secondary outcome measures for workstream 1 include confidence levels using Houghton's Scale of Prosthetic Use. | Confidence levels will be calculated using Houghton's Scale of Prosthetic Use. This is a 4 item instrument to capture prosthetic wearing habits. Users will have a total score out of 12 where a high score indicates great performance and great comfort. The first 3 items are scored on a 4 point scale ranging from 0-3 where 0=low level of confidence and 3 = high level of confidence. The 4th item is a yes/no question relating to stability where yes scores 0 and No scores 1. | Measures taken at baseline visit, data reported through study completion, an average of 1 year | |
| Secondary | The secondary outcome measures for workstream 1 include confidence levels using the EuroQol EQ-5D-5L questionnaire. | Confidence levels will be calculated using the EQ-5D-5L questionnaire. EQ-5D-5L is a standardized instrument for measuring generic health and mobility. Scores are calculated using a likert scale 1-5 to indicate levels of severity where 1 = no problems and 5 = high level of problems. The EQ-5D-5L also includes a Visual Analogue Scale (EQ-VAS) score, users rate their perception of their health on a scale of 0-100 where 0=worst and 100=best health. | Measures taken at baseline visit, data reported through study completion, an average of 1 year | |
| Secondary | The secondary outcome measures for workstream 2 are the lived experiences, processes of adjustment, body image, satisfaction with prosthesis and overall quality of life differences between the through knee and above knee amputees. | The analysis of semi-structured interviews and focus groups using a topic guide with self-designed questions relating to the lived experiences, processes of adjustment, body image, satisfaction with prosthesis. | Through study completion, an average of 1 year |