Clinical trial NCT04904003: Prosthetic Use, Mobility and Daily Functioning
Official title: Prosthetic Use, Mobility and Daily Functioning
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lower Leg Amputations
Keywords: Rehabilitation
Prosthetic mobility
Outcome measures
Lead sponsor: Oslo Metropolitan University
Sponsor class: OTHER
Collaborators: name: Sophies Minde Ortopedi
name: UniCare Bakke AS
First posted: 2021-05-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One explorative group, one intervention group and one control group
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Prosthetic Limb Users Survey of Mobility (Plus-M) Short form - 12 items
timeFrame: 4-8 weeks
measure: The Amputee Mobility Predictor (AMP).
timeFrame: 4-8 weeks
Secondary outcomes:
Other outcomes:
measure: Trinity Amputation and Prosthesis Experience Scale-Revised (TAPES-R) - psychosocial adjustment
timeFrame: 4-8 weeks
measure: Trinity Amputation and Prosthesis Experience Scale-Revised (TAPES-R) - activity restriction scale
timeFrame: 4-8 weeks
measure: Trinity Amputation and Prosthesis Experience Scale-Revised (TAPES-R) - satisfaction with prosthesis
timeFrame: 4-8 weeks
measure: Activities-Specific Balance Confidence scale (ABC)
timeFrame: 4-8 weeks
measure: EuroQoL 5L - health-related quality of life (EQ-5D-5L)
timeFrame: 4-8 weeks
measure: Two-minute walk test (2WT)
timeFrame: 4-8 weeks
measure: The L-Test of Functional Mobility (L-test)
timeFrame: 4-8 weeks
measure: General Perceived Self-Efficacy Scale (GSE)
timeFrame: 4-8 weeks
measure: Grip strength
timeFrame: 4-8 weeks
measure: Balance
timeFrame: 4-8 weeks
measure: Activity level
timeFrame: 4-8 weeks
measure: Gait characteristics - temporal parameters
timeFrame: 4-8 weeks
measure: Gait characteristics - spatial parameters
timeFrame: 4-8 weeks
measure: Gait characteristics - ground reaction force Gait characteristics - ground reaction force
timeFrame: 4-8 weeks
Locations:
city: Halden
country: Norway
facility: Unicare Bakke
state: Viken
city: Oslo
country: Norway
facility: OsloMet
Study officials:
affiliation: Associate professor and Head of research group
name: Terje Gjøvaag, PhD.
role: STUDY_DIRECTOR
References: