Prosthetic Use, Mobility and Daily Functioning

Not Applicable

Completed

• Conditions: Lower Leg Amputations
• Interventions: Other: Rehabilitation Intervention

• Registration Number: NCT04904003
• Lead Sponsor: Oslo Metropolitan University

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.

Study Timeline

• Study Start: 2021-04-09
• Study First Submitted: 2021-05-05
• Study First Submitted QC: 2021-05-21
• Study First Posted: 2021-05-27
• Status Verified: 2022-06
• Primary Completion: 2022-06-15
• Study Completion: 2022-06-15
• Last Update Submitted: 2022-10-10
• Last Update Posted: 2022-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experienced LLA - intervention	Rehabilitation Intervention	Experienced lower-limb amputees that complete a 4-week semi-structured individualized rehabilitation regime with extensive testing before and after the intervention.
Experienced LLA - controls	Rehabilitation Intervention	Experienced lower-limb amputees that will be tested with a 4-week interval. No intervention. This group will be matched to the group of experienced lower-limb amputees.
New LLA learning to use prosthesis	Rehabilitation Intervention	New lower-limb amputees that complete a 8-11 weeks semi-structured individualized rehabilitation regime with extensive testing before and after the intervention.

Primary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (2)

Unicare Bakke; 🇳🇴 Halden, Viken, Norway

OsloMet; 🇳🇴 Oslo, Norway