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

Recruiting

Phase 0 Results N/A

Trial Description

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.

Conditions

Interventions

  • Self-directed Upper Limb SaeboFlex Training Other
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: 8 individual case reviews
    Description: SaeboFlex Self-directed training

Trial Design

  • Masking: Open Label
  • Purpose: Treatment
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Action Research Arm Test (ARAT) Change from Baseline in upper limb function to 4, 8 and 12 weeks No
Primary Motricity Index (MI) Change from Baseline in upper limb voluntary contraction to 4, 8 and 12 weeks No
Secondary Motor Assessment Scale- Upper Limb Section (UL-MAS). Change from Baseline in upper limb function to 12 weeks No
Secondary Visual Analogue Scale Change from Baseline to 12 weeks No
Secondary Modified Barthel Index (MBI) Change from Baseline in Independence level to 4, 8 and 12 weeks No
Secondary Stroke Impact Scale (SIS) Change from Baseline to 12 weeks No
Secondary Berg Balance Test Change from Baseline in balance to 4, 8 and 12 weeks No
Secondary Questionnaire 12 weeks No
Secondary Adverse effects or events monitoring and recording throughout 12 weeks Yes

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