Personalisation of Prosthetic Care for Lower- Limb Amputees

NCT06243549 | Active Not Recruiting

• 1 other identifier: 321729
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

The global rise in lower-limb amputations is mainly due to diabetes and vascular complications. Amputations cause serious physical and psycho-social disabilities which impair locomotion and compromise patients quality of life. Biopsychosocial factors such as altered gait parameters, poor prosthetic fit, depression, fear avoidance behaviours and stigma increase the risk of individuals incurring lower back pain; the leading cause of secondary disability amongst persons with lower-limb amputation. Exploring the potential mechanistic pathways of lower back pain development is important to inform timely patient-centred programmes of care. Currently, limited information exists to inform the design of such programmes. Thus, there is a pressing need to understand the bio-behavioural, psychological, and social features of individuals with lower-limb amputation in the presence of lower back pain.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

• How do gait characteristics and muscle activations influence functional outcomes post-amputation and how do these variables influence the development of lower back pain?

  Monitoring patients gait and muscle activities of the erector spinae, latissimus dorsi, gluteus medius, and sound limb biceps femoris and rectus femoris, during walking at self-selected speed, and how these variables influence lower back pain, assessed through the Roland-Morris Disability Questionnaire (no scale, greater number of statements circled indicates a worse outcome; maximum score of 24), and patient functional outcomes, where the term 'function' refers to the comprehensive overview of each participant's everyday interactions and long-term targets, defined by the participant in terms of person-specific activities and goals.

  12-months

Secondary Outcomes (4)

• How does the gait of persons with lower-limb loss change over a period of 12-months?

  12-months

• What is the time-scale for the development of lower back pain post-amputation?

  12-months

• What is the relationship between lower back pain and other types of pain?

  12-months

• How many persons with lower-limb amputation develop lower back pain over the 12-month monitoring period?

  12-months

Eligibility Criteria

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

Study Population

Recruitment of persons with unilateral TFA and TTA of both vascular and traumatic aetiology will be attempted from the Bristol Centre for Enablement and the Portsmouth Enablement Centre (North Bristol NHS Trust and Portsmouth Hospitals University NHS Trust, respectively).

You may qualify if:

• Over 18 years old
• Unilaterally amputated
• Able to walk on level ground
• Newly fitted with a prosthetic (0-3-months post-amputation)

You may not qualify if:

• Balance disorders
• Patients who lack the capacity to consent for prosthetic use
• Patients at serious risk of sound foot which limits normal rehabilitation
• Transfer-in patients
• Persons with congenital lower-limb amputation

Sponsors & Collaborators

• University of Bath: lead
• University Hospitals Bristol and Weston NHS Foundation Trust: collaborator
• Portsmouth Hospitals NHS Trust: collaborator

Study Sites (2)

Bristol Centre for Enablement

Bristol, BS34 5BW, United Kingdom

Location

Portsmouth Enablement Centre

Portsmouth, PO3 6AD, United Kingdom

Location

Related Publications (1)

• Withey A, Cazzola D, Tabor A, Seminati E. Exploring the associations between the biomechanical and psychological mechanistic pathways of lower back pain development amongst persons with lower-limb amputation: A study protocol. PLoS One. 2025 Feb 6;20(2):e0314523. doi: 10.1371/journal.pone.0314523. eCollection 2025.

  PMID: 39913459 DERIVED

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 25, 2024
• First Posted: February 6, 2024
• Study Start: September 1, 2023
• Primary Completion: October 1, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)