Prototest: Weight-bearing Exercise for Trans-tibial Amputees

• Sponsor: University Rehabilitation Institute, Republic of Slovenia (Other)
• Overall Status: Completed
• CT.gov ID: NCT05095805
• Collaborator: Slovenian Research Agency (Other)
• Enrollment: 20
• Location: 1
• Arms: 2
• Actual Duration (Months): 2.6
• Patients Per Site Per Month: 7.8

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Amputation	Behavioral: additional weight-bearing exercise; Behavioral: standard weight-bearing exercise	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Weight-bearing Training Exercise May Improve Loading of Trans-tibial Prosthesis and Functional Gait
• Actual Study Start Date: Oct 14, 2021
• Actual Primary Completion Date: Dec 31, 2021
• Actual Study Completion Date: Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Test group additional weight-bearing exercise	Behavioral: additional weight-bearing exercise; Nintendo Wii Balance Board, real-time visual feedback, weight-bearing assessment by center of pressure
Active Comparator: Control group standard weight-bearing exercise	Behavioral: standard weight-bearing exercise; conventional training for fitting of initial prosthesis

Outcome Measures

Primary Outcome Measures

1. 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

2. Change in weight distribution in quiet standing [Assessment at baseline and after two weeks]

   COP assessment for 20s of quiet standing

Secondary Outcome Measures

1. Change in 10m walk test [Assessment at baseline and after two weeks]

2. Change in L-test [Assessment at baseline and after two weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Rehabilitation Institute, Republic of Slovenia	Ljubljana		Slovenia	1000

Sponsors and Collaborators

• University Rehabilitation Institute, Republic of Slovenia
• Slovenian Research Agency

Investigators

• Study Chair: Helena Burger, MD, PhD, University Rehabilitation Institute, Republic of Slovenia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Rehabilitation Institute, Republic of Slovenia
• ClinicalTrials.gov Identifier: NCT05095805
• Other Study ID Numbers: URIS202102
• First Posted: Oct 27, 2021
• Last Update Posted: Jan 27, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Rehabilitation Institute, Republic of Slovenia: trans-tibial prosthesis; weight-bearing; balance; centre of pressure

Study Results

No Results Posted as of Jan 27, 2022