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

NCT01453010 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2011-10-17

No results posted yet for this study

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.

Conditions

Interventions

OTHER

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.

Sponsors & Collaborators

  • Colchester Hospital University NHS Foundation Trust

    lead OTHER_GOV

Principal Investigators

  • Rebecca Stuck, BSc · Colchester Hospital University Foundation NHS Trust

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2012-05-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01453010 on ClinicalTrials.gov