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Search / Trial NCT01453010

Self-directed Upper Limb Training Using a SaeboFlex in Acute Stroke

Launched by COLCHESTER HOSPITAL UNIVERSITY NHS FOUNDATION TRUST · Oct 13, 2011

Trial Information

Current as of June 04, 2025

Unknown status

Keywords

Saebo Flex Stroke Rehabilitation Upper Limb Rehabilitation Acute Stroke

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

  • Inclusion criteria:
  • Subjects will:
  • Be either in-patients on Colchester Stroke Unit or,
  • Out-patients following an acute stroke admission to Colchester Stroke Unit
  • Be adults who have suffered a stroke between 3 and 84 days before recruitment
  • Have an anterior circulation stroke - i.e. must have weakness not ataxia
  • Have a substantially paretic hand and fingers and meet the criteria for the SaeboFlex orthosis as below
  • Have a previously fully functional upper limb (i.e. previous weakness, severe movement disorders, severe Rheumatoid Arthritis )
  • Be able to participate in self directed therapy (i.e. no severe visual or cognitive deficits precluding participation task repetitive practice and recording training times)
  • Are medically fit to participate in repetitive task practice as determined by the consultant (or GP if out-patient).
  • Saebo Flex requirements (inclusion criteria)
  • Subjects must have:
  • A minimum of 15 degrees passive wrist extension (fingers must be extended)
  • At least 15 degrees active shoulder motion in any plane
  • At least 15 degrees elbow flexion
  • At least ¼ range of active finger flexion (IP) flexion
  • Exclusion criteria:
  • Patients that are able to open and close his/her hand completely, 10 times keeping the wrist neutral while maintaining his / her maximum shoulder flexion are too good for the Saebo-flex. Other treatment options should be considered.
  • Severe joint deformities that could be worsened by using an orthosis, i.e. RA
  • Those patients with extremely poor skin integrity which may be cause irritation or skin damage.
  • We will not exclude stroke survivors on the basis of age or gender but subjects will need to be motivated for self-directed study.

About Colchester Hospital University Nhs Foundation Trust

Colchester Hospital University NHS Foundation Trust is a leading healthcare provider in the UK, dedicated to delivering high-quality patient care and advancing medical research through clinical trials. As a key participant in the National Health Service (NHS), the Trust is committed to integrating innovative treatment options and evidence-based practices into its services. With a focus on patient safety and ethical research, the Trust collaborates with various stakeholders to facilitate clinical studies that aim to improve health outcomes and enhance the understanding of various medical conditions. Its robust infrastructure and multidisciplinary expertise support a wide range of clinical research initiatives, contributing to the advancement of healthcare both locally and nationally.

Locations

Colchester, Essex, United Kingdom

Patients applied

0 patients applied

Trial Officials

Rebecca Stuck, BSc

Principal Investigator

Colchester Hospital University Foundation NHS Trust

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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