Prosthetic Use, Mobility and Daily Functioning

NCT ID: NCT04904003

Last Updated: 2022-10-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-09
• Study Completion Date: 2022-06-15

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.

Conditions

Lower Leg Amputations

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experienced LLA - intervention

Experienced lower-limb amputees that complete a 4-week semi-structured individualized rehabilitation regime with extensive testing before and after the intervention.

Group Type: EXPERIMENTAL

Rehabilitation Intervention

Intervention Type: OTHER

Strength, flexibility, endurance, balance, mobility, (self-efficacy)

Experienced LLA - controls

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.

Group Type: EXPERIMENTAL

Rehabilitation Intervention

Intervention Type: OTHER

Strength, flexibility, endurance, balance, mobility, (self-efficacy)

New LLA learning to use prosthesis

New lower-limb amputees that complete a 8-11 weeks semi-structured individualized rehabilitation regime with extensive testing before and after the intervention.

Group Type: EXPERIMENTAL

Rehabilitation Intervention

Intervention Type: OTHER

Strength, flexibility, endurance, balance, mobility, (self-efficacy)

Interventions

Rehabilitation Intervention

Strength, flexibility, endurance, balance, mobility, (self-efficacy)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sophies Minde Ortopedi

INDUSTRY

Sponsor Role: collaborator

UniCare Bakke AS

UNKNOWN

Sponsor Role: collaborator

Oslo Metropolitan University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Terje Gjøvaag, PhD.

Role: STUDY_DIRECTOR

Associate professor and Head of research group

Locations

Unicare Bakke

Halden, Akershus, Norway

OsloMet

Oslo, , Norway

Countries

Norway

Other Identifiers

2018/2577

Identifier Type: -

Identifier Source: org_study_id