Clinical trial NCT01453010: Self-directed Upper Limb Training Using a SaeboFlex in Acute Stroke
Official title: Self-directed Upper Limb Training Using a SaeboFlex With Acute Stroke Patients: 8 Single Case Reviews
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Stroke
Keywords: SaeboFlex
Stroke rehabilitation
Upper Limb Rehabilitation
Acute Stroke
Lead sponsor: Colchester Hospital University NHS Foundation Trust
Sponsor class: OTHER_GOV
First posted: 2011-10-17
Enrollment: 8
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 to improve motor recovery. Despite treatments, such as Constraint Induced Movement Therapy, showing promise, these in large have been have focused on high-intensity and repetitive task-specific practice. Patients with little hand or finger movements however may not be able to participate actively in task specific training.

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.


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.

Primary outcomes:
measure: Action Research Arm Test (ARAT)
timeFrame: Change from Baseline in upper limb function to 4, 8 and 12 weeks
measure: Motricity Index (MI)
timeFrame: Change from Baseline in upper limb voluntary contraction to 4, 8 and 12 weeks
Secondary outcomes:
measure: Motor Assessment Scale- Upper Limb Section (UL-MAS).
timeFrame: Change from Baseline in upper limb function to 12 weeks
measure: Visual Analogue Scale
timeFrame: Change from Baseline to 12 weeks
measure: Modified Barthel Index (MBI)
timeFrame: Change from Baseline in Independence level to 4, 8 and 12 weeks
measure: Stroke Impact Scale (SIS)
timeFrame: Change from Baseline to 12 weeks
measure: Berg Balance Test
timeFrame: Change from Baseline in balance to 4, 8 and 12 weeks
measure: Questionnaire
timeFrame: 12 weeks
measure: Adverse effects or events monitoring and recording
timeFrame: throughout 12 weeks
Other outcomes:
Locations:
city: Colchester
country: United Kingdom
facility: Colchester Hospital University Foundational NHS Trust
state: Essex
Study officials:
affiliation: Colchester Hospital University Foundation NHS Trust
name: Rebecca Stuck, BSc
role: PRINCIPAL_INVESTIGATOR
References: