SaeboFlex orthosis for upper limb training in acute stroke patients

• Research type

  Research Study

• Full title

  Neurophysiological investigation of the effects of SaeboFlex training on upper limb recovery in people early after stroke.

• IRAS ID

  148276

• Contact name

  Kath Mares

• Sponsor organisation

  University of East Anglia

• Research summary

  Weakness of the arm and hand after stroke affects everyday lives. People with substantial weakness may not be able to participate in proven treatments which require repeated practice of functional tasks. Using a dynamic hand orthosis called SaeboFlex may help by assisting patients to open their hand and allowing them to participate in repetitive task-specific therapy. This study will investigate the affect of the SaeboFlex orthosis on arm and hand function in patients who have had a stroke less than three months earlier.

  This is a feasibility study using a case control experimental design in one stroke rehabilitation unit. Participants will receive the intervention (SaeboFlex training) in addition to their usual physiotherapy for two weeks. They will then receive their usual physiotherapy only for a further two weeks. The measures of clinical outcome that will be used to compare the two periods will be: the ability to use the weaker arm and hand for functional tasks and the ability to produce voluntary contraction of weak muscles. These measures will be made before treatment begins, after 2 weeks and after 4 weeks.

  The study is designed as a feasibility study to find out whether the benefits of SaeboFlex training justify a subsequent larger scale trial. Embedded in the study is a measure to increase understanding of how SaeboFlex training might affect how the central nervous system (CNS) recovers after stroke. We know that CNS recovery involves reorganisation of nerve networks in the brain and spinal cord. We do not yet know how to use physical therapies to encourage beneficial reorganisation to improve outcomes after stroke. To investigate this we will use magnetic brain stimulation before and after the first treatment session, and at the end of the 2 week intervention period

• REC name

  East of England - Cambridgeshire and Hertfordshire Research Ethics Committee

• REC reference

  14/EE/0174

• Date of REC Opinion

  30 Jul 2014

• REC opinion

  Further Information Favourable Opinion