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Completed

NCT Number: NCT04904003

Prosthetic Use, Mobility and Daily Functioning

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Unicare Bakke, Halden, Akershus, Norway

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rehabilitation intervention

Other

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

Primary outcomes

  1. Prosthetic Limb Users Survey of Mobility (Plus-M) Short form - 12 items

    Time frame: 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.

  2. The Amputee Mobility Predictor (AMP).

    Time frame: 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.

Other outcomes

  1. Trinity Amputation and Prosthesis Experience Scale-Revised (TAPES-R) - psychosocial adjustment

    Time frame: 4-8 weeks

    The questionnaire examines psychosocial processes involved in adapting to the prosthesis as well as specific needs when using prosthesis.

    Psychosocial adjustment - general subscale, provide a score range from 1.0-4.0. High scores indicative of positive adjustment.

    Psychosocial adjustment - social subscale, provide a score range from 1.0-4.0. High scores indicative of positive adjustment.

    Psychosocial adjustment - adjustment to limitation subscale, provide a score range from 1.0-4.0. High scores indicative of positive adjustment.

  2. Trinity Amputation and Prosthesis Experience Scale-Revised (TAPES-R) - activity restriction scale

    Time frame: 4-8 weeks

    The questionnaire examines psychosocial processes involved in adapting to the prosthesis as well as specific needs when using prosthesis.

    Activity restriction scale, provide a score range from 0.0-2.0. High scores is indicative of activity restriction.

  3. Trinity Amputation and Prosthesis Experience Scale-Revised (TAPES-R) - satisfaction with prosthesis

    Time frame: 4-8 weeks

    The questionnaire examines psychosocial processes involved in adapting to the prosthesis as well as specific needs when using prosthesis.

    Satisfaction with prosthesis - aesthetic satisfaction subscale, provide a score range from 3-9. High scores is indicative of satisfaction with prosthesis.

    Satisfaction with prosthesis - functional satisfaction subscale, provide a score range from 5-15. High scores is indicative of satisfaction with prosthesis.

  4. Activities-Specific Balance Confidence scale (ABC)

    Time frame: 4-8 weeks

    The questionnaire measures how confident LLA are in performing ADL without losing balance or becoming unsteady. ABC provide a score range from 0-64. High scores indicate better outcome.

  5. EuroQoL 5L - health-related quality of life (EQ-5D-5L)

    Time frame: 4-8 weeks

    Standardized generic instrument used to measure health outcomes and health-related quality of life. Each question provide a score range from 1-5. High scores indicate worse outcome.

  6. Two-minute walk test (2WT)

    Time frame: 4-8 weeks

    The test measures functional mobility and the distance covered in two minutes.

  7. The L-Test of Functional Mobility (L-test)

    Time frame: 4-8 weeks

    The test measures functional mobility and is designed specifically for LLA. The LLA walks as fast as possible in a 3 x 7 meter L-shaped walkway that requires change of direction both ways.

  8. General Perceived Self-Efficacy Scale (GSE)

    Time frame: 4-8 weeks

    Assesses self-efficacy when coping with challenging demands in life. GSE provide a score range from 10-40. High scores indicate better outcome.

  9. Grip strength

    Time frame: 4-8 weeks

    Grip strength as measured by hand dynamometer

  10. Balance

    Time frame: 4-8 weeks

    Postural balance measured as center of pressure excursion by insoles with pressure sensors and a gyroscope sensor.

  11. Activity level

    Time frame: 4-8 weeks

    Number of steps measured by an accelerometer

  12. Gait characteristics - temporal parameters

    Time frame: 4-8 weeks

    Gait characteristics measured in seconds by insoles with pressure sensors and gyroscope sensor

  13. Gait characteristics - spatial parameters

    Time frame: 4-8 weeks

    Gait characteristics measured in meters by insoles with pressure sensors and gyroscope sensor

  14. Gait characteristics - ground reaction force Gait characteristics - ground reaction force

    Time frame: 4-8 weeks

    Gait characteristics measured in Newton by insoles with pressure sensors and gyroscope sensor

Sponsors and collaborators

Lead sponsor

Oslo Metropolitan University

Other

Collaborators

  • Sophies Minde Ortopedi
  • UniCare Bakke AS

Registry information

Acronym: ProMob

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 27, 2021
Registry last updated
Oct 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.