CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 45 enrolled
Drug / intervention
Robotic-assisted therapy +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02079779
NCT02079779N/ACompleted

Study of the Effectiveness of an Interactive Robot for the Rehabilitation of the Upper Limb in Acute Stroke Patients by Evaluating the 3 Fields of the ICF: a Prospective, Randomized, Controlled, Simple Blind Study

Cliniques universitaires Saint-Luc- Université Catholique de Louvain·interventional·Posted Mar 6, 2014·Updated Aug 24, 2018

In Brief

A clinical study evaluating Robotic-assisted therapy and Classical therapy for Acute Stroke. Completed, enrolled 45 participants across 3 sites.

Detailed Summary

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 robotic-assisted therapy, respectively.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Stroke
CountriesBelgium
Collaborators--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 6, 2014
Enrollment StartJan 9, 2015
Primary CompletionJan 9, 2015
Study CompletionOct 2, 2017
TodayJul 2, 2026
Enrollment to primary: 0 daysPosted 12.3 years ago

Interventions

Robotic-assisted therapyother

The robotic device is designed to intensively rehabilitate the upper limb. Indeed, this robot allows the patient to perform a lot of active, passive, or assisted exercises. The level of assistance is determined and provided by the robot in function of the patient performance (i.e. quality of movements).

Classical therapyother

Conventional therapy will be performed by therapists specialized in neuro-rehabilitation