rehabilitation intervention
OtherStrength, flexibility, endurance, balance, mobility, (self-efficacy)
NCT Number: NCT04904003
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Unicare Bakke, Halden, Akershus, Norway
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for experienced users of prosthesis - intervention group:
Inclusion criteria
for experienced users of prosthesis - control group:
Inclusion criteria
for new users of prosthesis:
Exclusion criteria
Strength, flexibility, endurance, balance, mobility, (self-efficacy)
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.
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.
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.
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.
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.
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.
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.
Time frame: 4-8 weeks
The test measures functional mobility and the distance covered in two minutes.
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.
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.
Time frame: 4-8 weeks
Grip strength as measured by hand dynamometer
Time frame: 4-8 weeks
Postural balance measured as center of pressure excursion by insoles with pressure sensors and a gyroscope sensor.
Time frame: 4-8 weeks
Number of steps measured by an accelerometer
Time frame: 4-8 weeks
Gait characteristics measured in seconds by insoles with pressure sensors and gyroscope sensor
Time frame: 4-8 weeks
Gait characteristics measured in meters by insoles with pressure sensors and gyroscope sensor
Time frame: 4-8 weeks
Gait characteristics measured in Newton by insoles with pressure sensors and gyroscope sensor
Oslo Metropolitan University
Other
Acronym: ProMob
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View the official ClinicalTrials.gov record (opens in a new tab)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.