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Status:

UNKNOWN

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

Lead Sponsor:

Colchester Hospital University NHS Foundation Trust

Conditions:

Stroke

Eligibility:

All Genders

16+ years

Phase:

EARLY_PHASE1

Brief Summary

Arm and hand weakness as a result of stroke occurs in approximately 70% of stroke survivors and causes huge loss of function and independence. A wide range of treatment approaches have been developed ...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

    Key Trial Info

    Start Date :

    May 1 2011

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    Estimated Enrollment :

    8 Patients enrolled

    Trial Details

    Trial ID

    NCT01453010

    Start Date

    May 1 2011

    Last Update

    October 17 2011

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    Colchester Hospital University Foundational NHS Trust

    Colchester, Essex, United Kingdom, CO45JL