Self-directed Upper Limb Training Using a SaeboFlex in Acute Stroke
NCT ID: NCT01453010
Last Updated: 2011-10-17
Study Results
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Basic Information
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UNKNOWN
EARLY_PHASE1
8 participants
INTERVENTIONAL
2011-05-31
Brief Summary
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The SaeboFlex is a dynamic orthosis, with a spring-loaded feature that facilitates opening of the fingers and hand. This allows the patient to grasp and release objects repeatedly, hence enabling participation in repetitive task practice and increasing potential for motor recovery. Despite the SaeboFlex being used successfully in several centers in the country and internationally, research to provide evidence of effectiveness is scarce. As a consequence funding for the SaeboFlex is limited and usually requires patients' to fund their own.
The study aims to explore the potential benefits and feasibility of participating in a Self-directed SaeboFlex training program to allow repetitive task practice in patients early after stroke.
Subjects will undergo a 12-week training program comprising of a maximum of 3 x 45 minute sessions a day. Activities focus on grasping and releasing balls and reaching for targets, wearing the SaeboFlex for the majority of the session. At the end of each session the SaeboFlex is removed and the hand is incorporated into functional tasks as able. Subjects will be set individualized training program by a Saebo-trained therapist. The program will be graded and progressed at a rate that is appropriate to each individual.
The study will measure and follow-up 8 subjects to explore improvements in recovery and functional ability of the upper limb and affect on dependency levels. It will also explore the level of intensity patients early after stroke can tolerate and how they participate in self-directed therapy. All patients will meet the inclusion criteria and be motivated to undergo the specific SaeboFlex self-directed training program. Subjects will record the time and intensity of their training sessions and also their routine upper limb therapy. Patients will be assessed before, during and after the 3 months training. If these cases show promise the study will support the need for large trials including clinical efficacy and dose finding studies.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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8 individual case reviews
SaeboFlex Self-directed training
Self-directed Upper Limb SaeboFlex Training
Participants undergo a 12 week self directed upper limb training programme with the SaeboFlex upper limb orthosis. Training consists of a maximum of 3 x 45 minute sessions a day.
Participants are closely monitored at least once a week by a saebo-trained therapist.
Interventions
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Self-directed Upper Limb SaeboFlex Training
Participants undergo a 12 week self directed upper limb training programme with the SaeboFlex upper limb orthosis. Training consists of a maximum of 3 x 45 minute sessions a day.
Participants are closely monitored at least once a week by a saebo-trained therapist.
Eligibility Criteria
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Inclusion Criteria
* 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).
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 ΒΌ range of active finger flexion (IP) flexion
Exclusion Criteria
* 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.
16 Years
ALL
No
Sponsors
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Colchester Hospital University NHS Foundation Trust
OTHER_GOV
Responsible Party
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Principal Investigators
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Rebecca Stuck, BSc
Role: PRINCIPAL_INVESTIGATOR
Colchester Hospital University Foundation NHS Trust
Locations
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Colchester Hospital University Foundational NHS Trust
Colchester, Essex, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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11/H0302/8
Identifier Type: -
Identifier Source: org_study_id