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Clinical Trials/ISRCTN15043643
ISRCTN15043643
Completed
未知

STEPFORWARD: Patient acceptability of a novel prosthetic device: a randomised feasibility study in older patients with vascular-related amputations and multimorbidities

Hull & East Yorkshire NHS Trust0 sites55 target enrollmentApril 19, 2018
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ConditionsDisorder of arteries and arterioles, unspecifiedNot Applicable

Overview

Phase
未知
Intervention
Not specified
Conditions
Disorder of arteries and arterioles, unspecified
Sponsor
Hull & East Yorkshire NHS Trust
Enrollment
55
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

2019 Protocol article in https://pubmed.ncbi.nlm.nih.gov/31542768/ protocol (added 06/01/2021) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33737440/ (added 22/03/2021) 2023 Other publications in https://pubmed.ncbi.nlm.nih.gov/37088918/ Qualitative experience (added 24/04/2023)

Registry
who.int
Start Date
April 19, 2018
End Date
March 31, 2020
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Hull & East Yorkshire NHS Trust

Eligibility Criteria

Inclusion Criteria

  • •Current inclusion criteria as of 10/05/2018:
  • •1\. Aged over 50 years
  • •2\. Has a unilateral amputation
  • •3\. Has a below\-knee amputation only
  • •4\. Has an amputation due to vascular reasons (diabetes, peripheral vascular disease), neurological disorders (i.e. diabetic neuropathy) or life\-limiting illness (i.e. tumour, cancer)
  • •5\. Is categorised as 'limited mobility’ (K2 classification or SIGAM mobility grade C or D)
  • •6\. Is currently using a standard prosthetic foot\-ankle (e.g. SACH, uniaxial, multiflex or other K1/K2 feet) that does not adjust to sloped surfaces and is not self\-aligning
  • •7\. Has been using a prosthesis for at least 12 months, with the same socket for a minimum of 3 months
  • •8\. Has had a stable residual limb for at least 3 months (i.e. stable in volume and without cuts or wounds; daily management of volume with socks and liners is acceptable)
  • •9\. Is willing to trial a new prosthesis for a 12\-week period (if allocated to intervention arm)

Exclusion Criteria

  • •A patient will be excluded for the following reasons:
  • •1\. Has contraindications of wearing their current prosthesis (e.g., open wound, infection)
  • •2\. Has contraindications of wearing the novel prosthesis according to manufacturer’s instructions (i.e., a long residual limb \- intact side measurement from mid patella tendon to ground minus the socket measurement from mid patella tendon to distal end of socket female\-pyramid\-adaptor should be at least 115mm)
  • •3\. Has had a recent cerebrovascular event, such as a stroke
  • •4\. Has a disease that severely affects their memory, such as dementia or Alzheimer’s

Outcomes

Primary Outcomes

Not specified

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