Amputation
Conditions
Keywords
trans-tibial prosthesis, weight-bearing, balance, centre of pressure
Brief summary
A simple weight-bearing exercise has been designed using off-the-shelves devices (Nintendo Wii Balance Board) and centre of pressure (COP) analysis software (Python) for trans-tibial amputees receiving their first prosthesis. A pilot randomised control study will be conducted to check the progress with weight-bearing training using COP-based objective measures. Additionally, gait and functional task performance will be assessed by means of clinical test. Participants will be divided into 2 groups: test group (performing additional weight-bearing exercises) and control group (receiving only conventional training for fitting of initial prosthesis).
Detailed description
Each patient meeting the inclusion criteria will be randomised to either the test group or the control group. The patients will perform ten training sessions with the initial prosthesis, each session lasting for about 30 minutes, within the period of two weeks. They will be assessed at baseline and after the training program.
Interventions
BEHAVIORALadditional weight-bearing exercise
Nintendo Wii Balance Board, real-time visual feedback, weight-bearing assessment by center of pressure
BEHAVIORALstandard weight-bearing exercise
conventional training for fitting of initial prosthesis
Sponsors
Slovenian Research Agency
University Rehabilitation Institute, Republic of Slovenia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* trans-tibial amputation, * fitted with first trans-tibial prosthesis, * independent mobility for 50m with or without assistive aid, * Functional Independence Measure (FIM) Stairs locomotion scale ≥ 5, * ability to follow the instructions, Mini Mental State Examination (MMSE) \> 25, * no severe visual problems, ble to see computer screen, * willing to participate.
Exclusion criteria
* bilateral lower limb amputation or any other level of unilateral lower limb amputation, * not candidates for prosthetic fitting.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in centre of pressure (COP) from baseline | Assessment at baseline and after two weeks | Calculation of COP (transversal plane, symmetry index, lateral, sagittal directions) from 4 pressure sensors built into the balance board |
| Change in weight distribution in quiet standing | Assessment at baseline and after two weeks | COP assessment for 20s of quiet standing |
Secondary
| Measure | Time frame |
|---|---|
| Change in 10m walk test | Assessment at baseline and after two weeks |
| Change in L-test | Assessment at baseline and after two weeks |
Countries
Slovenia
Outcome results
None listed