Prosthetic Use, Mobility and Daily Functioning (ProMob)

Oslo Metropolitan University

Status: Completed

Conditions: Lower Leg Amputations

Treatments: Other: Rehabilitation Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04904003

2018/2577

Details and patient eligibility

About

The goal of the project is to explore which elements of rehabilitation that influence mobility in new and experienced unilateral lower-limb amputees.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria for experienced users of prosthesis - intervention group:

• 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

Inclusion Criteria for experienced users of prosthesis - control group:

• 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

Inclusion Criteria for new users of prosthesis:

• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

Experienced LLA - intervention

Experimental group

Description:

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

Treatment:

Other: Rehabilitation Intervention

Experienced LLA - controls

Experimental group

Description:

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.

Treatment:

Other: Rehabilitation Intervention

New LLA learning to use prosthesis

Experimental group

Description:

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

Treatment:

Other: Rehabilitation Intervention