Prosthetic Use, Mobility and Daily Functioning (ProMob)

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

Study Overview

• Status: Completed
• Conditions: Lower Leg Amputations
• Intervention / Treatment: Other: Rehabilitation Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0130
    • OsloMet
  • Viken
    • Halden, Viken, Norway, 1765
      • Unicare Bakke

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Rehabilitation Intervention; Strength, flexibility, endurance, balance, mobility, (self-efficacy)
Experimental: 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.	Other: Rehabilitation Intervention; Strength, flexibility, endurance, balance, mobility, (self-efficacy)
Experimental: 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.	Other: Rehabilitation Intervention; Strength, flexibility, endurance, balance, mobility, (self-efficacy)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prosthetic Limb Users Survey of Mobility (Plus-M) Short form - 12 items	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.	4-8 weeks
The Amputee Mobility Predictor (AMP).	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.	4-8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trinity Amputation and Prosthesis Experience Scale-Revised (TAPES-R) - psychosocial adjustment	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.	4-8 weeks
Trinity Amputation and Prosthesis Experience Scale-Revised (TAPES-R) - activity restriction scale	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.	4-8 weeks
Trinity Amputation and Prosthesis Experience Scale-Revised (TAPES-R) - satisfaction with prosthesis	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.	4-8 weeks
Activities-Specific Balance Confidence scale (ABC)	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.	4-8 weeks
EuroQoL 5L - health-related quality of life (EQ-5D-5L)	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.	4-8 weeks
Two-minute walk test (2WT)	The test measures functional mobility and the distance covered in two minutes.	4-8 weeks
The L-Test of Functional Mobility (L-test)	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.	4-8 weeks
General Perceived Self-Efficacy Scale (GSE)	Assesses self-efficacy when coping with challenging demands in life. GSE provide a score range from 10-40. High scores indicate better outcome.	4-8 weeks
Grip strength	Grip strength as measured by hand dynamometer	4-8 weeks
Balance	Postural balance measured as center of pressure excursion by insoles with pressure sensors and a gyroscope sensor.	4-8 weeks
Activity level	Number of steps measured by an accelerometer	4-8 weeks
Gait characteristics - temporal parameters	Gait characteristics measured in seconds by insoles with pressure sensors and gyroscope sensor	4-8 weeks
Gait characteristics - spatial parameters	Gait characteristics measured in meters by insoles with pressure sensors and gyroscope sensor	4-8 weeks
Gait characteristics - ground reaction force Gait characteristics - ground reaction force	Gait characteristics measured in Newton by insoles with pressure sensors and gyroscope sensor	4-8 weeks

Collaborators and Investigators

• Sponsor: Oslo Metropolitan University
• Collaborators: Sophies Minde Foundation; UniCare Bakke AS
• Investigators: Study Director: Terje Gjøvaag, PhD., Associate professor and Head of research group

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2021
• Primary Completion (Actual): June 15, 2022
• Study Completion (Actual): June 15, 2022

Study Registration Dates

• First Submitted: May 5, 2021
• First Submitted That Met QC Criteria: May 21, 2021
• First Posted (Actual): May 27, 2021

Study Record Updates

• Last Update Posted (Actual): October 12, 2022
• Last Update Submitted That Met QC Criteria: October 10, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Rehabilitation; Outcome measures; Prosthetic mobility
• Other Study ID Numbers: 2018/2577

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: There is not a plan to make IPD available. The GDPR-regulations make sharing of research data both time-consuming and difficult.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No