Weight-bearing Exercise for Trans-tibial Amputees (Prototest)

University Rehabilitation Institute, Republic of Slovenia

Status: Completed

Conditions: Amputation

Treatments: Behavioral: additional weight-bearing exercise; Behavioral: standard weight-bearing exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT05095805

URIS202102

Details and patient eligibility

About

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).

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Test group

Experimental group

Description:

additional weight-bearing exercise

Treatment:

Behavioral: additional weight-bearing exercise

Control group

Active Comparator group

Description:

standard weight-bearing exercise

Treatment:

Behavioral: standard weight-bearing exercise