Comparing OutcomeS of Through Knee and Above Knee Amputation

NCT ID: NCT04120558

Last Updated: 2022-07-21

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-06-05
• Study Completion Date: 2022-10-31

Brief Summary

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.

Conditions

Through Knee Amputation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Through knee amputees

Community dwelling individuals with through knee amputation of all mobility levels.

Qualitative interviews and focus groups

Intervention Type: OTHER

Semi-structured interviews will be undertaken with at least 24 and up to as many as 36 through knee and above knee amputees. A topic guide will be used to interview participants about perceived functional ability, body image, adapting post amputation and overall quality of life. A sampling frame will be used to ensure a range of views are sought (e.g. both men and women with through and above knee amputations; and with different mobility levels). Thematic analysis will be used to analyse the data. Focus group discussions will be informed by the findings of the interviews.

The themes that emerge from the semi-structured interviews will be further explored using focus groups and allow for comparison of the experiences between through knee and above knee amputees.

Functional mobility tests and questionnaires

Intervention Type: OTHER

Function in sitting and sit-and-reach will be assessed in non-ambulatory (wheelchair users) individuals. An overall score for each sitting activity will be recorded and the distance reached will be calculated.

Walking, timed-up-and-go, L-test, balance in sitting and standing, seated activities will be assessed in ambulatory (prosthetic using) individuals. The time taken, distance walked, distance reached, and the overall scores for each activity will be compared between the two groups. Fear of falls and confidence levels when performing tasks will be investigated using two questionnaires.

The EQ-5D-5L and SF-36 will be issued to the non-ambulatory and ambulatory participants to complete when attending the testing session.

The Locomotor Capability Index - 5 (LCI-5), Activities-specific Balance Confidence Scale (ABC-UK) and Houghton scale of prosthetic use in people with lower-extremity amputations

Above knee amputees

Community dwelling individuals with above knee amputation of all mobility levels.

Qualitative interviews and focus groups

Intervention Type: OTHER

Semi-structured interviews will be undertaken with at least 24 and up to as many as 36 through knee and above knee amputees. A topic guide will be used to interview participants about perceived functional ability, body image, adapting post amputation and overall quality of life. A sampling frame will be used to ensure a range of views are sought (e.g. both men and women with through and above knee amputations; and with different mobility levels). Thematic analysis will be used to analyse the data. Focus group discussions will be informed by the findings of the interviews.

The themes that emerge from the semi-structured interviews will be further explored using focus groups and allow for comparison of the experiences between through knee and above knee amputees.

Functional mobility tests and questionnaires

Intervention Type: OTHER

Function in sitting and sit-and-reach will be assessed in non-ambulatory (wheelchair users) individuals. An overall score for each sitting activity will be recorded and the distance reached will be calculated.

Walking, timed-up-and-go, L-test, balance in sitting and standing, seated activities will be assessed in ambulatory (prosthetic using) individuals. The time taken, distance walked, distance reached, and the overall scores for each activity will be compared between the two groups. Fear of falls and confidence levels when performing tasks will be investigated using two questionnaires.

The EQ-5D-5L and SF-36 will be issued to the non-ambulatory and ambulatory participants to complete when attending the testing session.

The Locomotor Capability Index - 5 (LCI-5), Activities-specific Balance Confidence Scale (ABC-UK) and Houghton scale of prosthetic use in people with lower-extremity amputations

Interventions

Qualitative interviews and focus groups

Semi-structured interviews will be undertaken with at least 24 and up to as many as 36 through knee and above knee amputees. A topic guide will be used to interview participants about perceived functional ability, body image, adapting post amputation and overall quality of life. A sampling frame will be used to ensure a range of views are sought (e.g. both men and women with through and above knee amputations; and with different mobility levels). Thematic analysis will be used to analyse the data. Focus group discussions will be informed by the findings of the interviews.

The themes that emerge from the semi-structured interviews will be further explored using focus groups and allow for comparison of the experiences between through knee and above knee amputees.

Intervention Type: OTHER

Functional mobility tests and questionnaires

Function in sitting and sit-and-reach will be assessed in non-ambulatory (wheelchair users) individuals. An overall score for each sitting activity will be recorded and the distance reached will be calculated.

Walking, timed-up-and-go, L-test, balance in sitting and standing, seated activities will be assessed in ambulatory (prosthetic using) individuals. The time taken, distance walked, distance reached, and the overall scores for each activity will be compared between the two groups. Fear of falls and confidence levels when performing tasks will be investigated using two questionnaires.

The EQ-5D-5L and SF-36 will be issued to the non-ambulatory and ambulatory participants to complete when attending the testing session.

The Locomotor Capability Index - 5 (LCI-5), Activities-specific Balance Confidence Scale (ABC-UK) and Houghton scale of prosthetic use in people with lower-extremity amputations

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Hull

OTHER

Sponsor Role: collaborator

Hull University Teaching Hospitals NHS Trust

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hull University Teaching Hospitals NHS Trust

Hull, East Riding Of Yorkshire, United Kingdom

Countries

United Kingdom

Other Identifiers

R2378

Identifier Type: -

Identifier Source: org_study_id