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Efficacy Study of an Interactive Robot for the Rehabilitation of the Upper Limb in Acute Stroke Patients

NCT02079779 · Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Updated 24 Aug 2018

What is being tested
Robotic-assisted therapy; Classical therapy
For
Acute Stroke
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 18 years to 90 years. About 45 people. The full rules are on the registry page.
Where
Belgium (3 sites)
When
Starts or started 9 Jan 2015, ends 2 Oct 2017. Registered 6 March 2014.
Results
None posted yet.

In the researchers' words

Stroke is the principal cause of permanent disability within the investigators population. This incapacity justifies an intensive and prolonged multidisciplinary rehabilitation, which can be optimized by robotics. The investigators team has developed a robot designed to rehabilitate the upper limb. This robot allows the patient to perform active, passive, or assisted exercises. The system is also able to assess movement quality and to provide a feedback to the patient and the therapist via a graphical interface. This therapy is designed to improve functional recovery of patients, and then their quality of life. Few quality studies have evaluated the efficacy of robotic assisted therapy in patients at the acute stage of rehabilitation (\< 3 months post stroke) when most improvements are observed. Thus, the aim of this study was to objectify the effectiveness of robotic-assisted rehabilitation in the acute stage after stroke by evaluating the 3 fields of the ICF (International Classification of Functioning, Disability and Health) and performing a prospective multicenter randomized controlled single blind trial. In this study, 60 stroke patients will be recruited and randomized into two groups. All patients will receive a similar classical rehabilitation as a basis. Patients of the control and experimental groups will receive a supplement of classical rehabilitation and…
ClinicalTrials.gov, NCT02079779

Sites

  • Cliniques Universitaires Saint LucBrussels, Belgium
  • Centre Hospitalier ValidaBrussels, Belgium
  • Centre Neurologique William LennoxOttignies, Belgium