Prosthetic Use, Mobility and Daily Functioning

NCT04904003 | Completed DMC

• 1 other identifier: 2018/2577
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Lower Leg Amputations

Keywords

Rehabilitation; Prosthetic mobility; Outcome measures

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (14)

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

  4-8 weeks

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

  4-8 weeks

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

  4-8 weeks

Study Arms (3)

Experienced LLA - intervention

EXPERIMENTAL

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

Experienced LLA - controls

EXPERIMENTAL

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

New LLA learning to use prosthesis

EXPERIMENTAL

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

Interventions

Rehabilitation Intervention OTHER

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

Experienced LLA - controls; Experienced LLA - intervention; New LLA learning to use prosthesis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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
• Unilaterally amputated (above the ankle joint / under the hip joint)
• No prior record of use of prosthesis
• Participation approved by physician

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo Metropolitan University: lead
• Sophies Minde Ortopedi: collaborator
• UniCare Bakke AS: collaborator

Study Sites (2)

Unicare Bakke

Halden, Akershus, 1765, Norway

Location

OsloMet

Oslo, 0130, Norway

Location

Study Officials

• Terje Gjøvaag, PhD.

  Associate professor and Head of research group

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: One explorative group, one intervention group and one control group

Study Record Dates

• First Submitted: May 5, 2021
• First Posted: May 27, 2021
• Study Start: April 9, 2021
• Primary Completion: June 15, 2022
• Study Completion: June 15, 2022
• Last Updated: October 12, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

NO (2)