Lower Leg Amputations
Conditions
Keywords
Rehabilitation, Prosthetic mobility, Outcome measures
Brief summary
The goal of the project is to explore which elements of rehabilitation that influence mobility in new and experienced unilateral lower-limb amputees.
Detailed description
Both new and experienced unilateral lower limb amputees (LLA) describe difficulties when ambulating intentionally and independently from one place to another using prosthesis. In LLA, this decreased ability to mobilize affect daily functioning and may result in low activity-levels, impeded social participation and reduced health-related quality of life. Both primary and secondary rehabilitation of LLA have implications for functional mobility. The consensus among health professionals is that LLA should train to improve their ability to ambulate. However, knowledge from research regarding which elements that constitute effective training and how systematic exercise affects body structures, functions, activity and participation in lower limb amputees, is limited. There also is a lack of knowledge of how prosthetic users endure and process the challenges regarding mobility, how they adapt to the use of their prosthesis, how safe they are ambulating using the prosthesis, and how pain and psychosocial issues affect their perceived health and mobility. The aim of this Ph.D.-project is to explore how a period of semi-standardized individualized rehabilitation originating from an evidence-based approach, affect the functional mobility of both new and experienced LLA, and how LLA process the loss of a limb and challenges during ambulation.
Interventions
Strength, flexibility, endurance, balance, mobility, (self-efficacy)
Sponsors
Sophies Minde Ortopedi
UniCare Bakke AS
Oslo Metropolitan University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
One explorative group, one intervention group and one control group
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
for experienced users of prosthesis - intervention group: * Unilaterally amputated (above the ankle joint / under the hip joint) * Minimum 12 months since amputation * Have a well-adapted prosthesis before baseline measurements * Not attended an organized, regular training program for the last 6 months * Uses the prosthesis on a daily basis * Participation approved by physician Inclusion Criteria for experienced users of prosthesis - control group: * Unilaterally amputated (above the ankle joint / under the hip joint) * Minimum 12 months since amputation * Have a well-adapted prosthesis before baseline measurements * Daily use of the prosthesis * Not attended an organized, regular training program in the last 6 months * No participation in regular and systematic training between pre- and post-testing Inclusion Criteria for new users of prosthesis: * Unilaterally amputated (above the ankle joint / under the hip joint) * No prior record of use of prosthesis * Participation approved by physician
Exclusion criteria
* Bilaterally amputated over ankle joint * Lack of understanding of Norwegian language (oral, written) * Neurological disorders affecting gait function * Skin lesion or abrasion on the stump or remaining extremity affecting mobility and function * Other issues that complicate participation in a rehabilitation intervention
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prosthetic Limb Users Survey of Mobility (Plus-M) Short form - 12 items | 4-8 weeks | A questionnaire that measures different aspects of mobility in lower-limb amputees (LLA) using prosthesis. PLUS-M provide a score range from 17.5 to 76.6. High scores indicate better outcome. |
| The Amputee Mobility Predictor (AMP). | 4-8 weeks | The test is designed to measure mobility and ability to move with prosthesis (AMPPro) and without prosthesis (AMPNoPro). AMPPro provide a score range from 0-47. AMPNoPro provide a score range from 0-43. High scores indicate better outcome. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Trinity Amputation and Prosthesis Experience Scale-Revised (TAPES-R) - satisfaction with prosthesis | 4-8 weeks | The questionnaire examines psychosocial processes involved in adapting to the prosthesis as well as specific needs when using prosthesis. Satisfaction with prosthesis - aesthetic satisfaction subscale, provide a score range from 3-9. High scores is indicative of satisfaction with prosthesis. Satisfaction with prosthesis - functional satisfaction subscale, provide a score range from 5-15. High scores is indicative of satisfaction with prosthesis. |
| Activities-Specific Balance Confidence scale (ABC) | 4-8 weeks | The questionnaire measures how confident LLA are in performing ADL without losing balance or becoming unsteady. ABC provide a score range from 0-64. High scores indicate better outcome. |
| EuroQoL 5L - health-related quality of life (EQ-5D-5L) | 4-8 weeks | Standardized generic instrument used to measure health outcomes and health-related quality of life. Each question provide a score range from 1-5. High scores indicate worse outcome. |
| Two-minute walk test (2WT) | 4-8 weeks | The test measures functional mobility and the distance covered in two minutes. |
| The L-Test of Functional Mobility (L-test) | 4-8 weeks | The test measures functional mobility and is designed specifically for LLA. The LLA walks as fast as possible in a 3 x 7 meter L-shaped walkway that requires change of direction both ways. |
| General Perceived Self-Efficacy Scale (GSE) | 4-8 weeks | Assesses self-efficacy when coping with challenging demands in life. GSE provide a score range from 10-40. High scores indicate better outcome. |
| Trinity Amputation and Prosthesis Experience Scale-Revised (TAPES-R) - psychosocial adjustment | 4-8 weeks | The questionnaire examines psychosocial processes involved in adapting to the prosthesis as well as specific needs when using prosthesis. Psychosocial adjustment - general subscale, provide a score range from 1.0-4.0. High scores indicative of positive adjustment. Psychosocial adjustment - social subscale, provide a score range from 1.0-4.0. High scores indicative of positive adjustment. Psychosocial adjustment - adjustment to limitation subscale, provide a score range from 1.0-4.0. High scores indicative of positive adjustment. |
| Balance | 4-8 weeks | Postural balance measured as center of pressure excursion by insoles with pressure sensors and a gyroscope sensor. |
| Activity level | 4-8 weeks | Number of steps measured by an accelerometer |
| Gait characteristics - temporal parameters | 4-8 weeks | Gait characteristics measured in seconds by insoles with pressure sensors and gyroscope sensor |
| Gait characteristics - spatial parameters | 4-8 weeks | Gait characteristics measured in meters by insoles with pressure sensors and gyroscope sensor |
| Gait characteristics - ground reaction force Gait characteristics - ground reaction force | 4-8 weeks | Gait characteristics measured in Newton by insoles with pressure sensors and gyroscope sensor |
| Grip strength | 4-8 weeks | Grip strength as measured by hand dynamometer |
| Trinity Amputation and Prosthesis Experience Scale-Revised (TAPES-R) - activity restriction scale | 4-8 weeks | The questionnaire examines psychosocial processes involved in adapting to the prosthesis as well as specific needs when using prosthesis. Activity restriction scale, provide a score range from 0.0-2.0. High scores is indicative of activity restriction. |
Countries
Norway
Outcome results
None listed