MedTrace Logo

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

NCT02079779 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2018-08-24

No results posted yet for this study

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.

Conditions

  • Acute Stroke

Interventions

OTHER

Robotic-assisted therapy

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).

OTHER

Classical therapy

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

Sponsors & Collaborators

  • Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    lead OTHER

Principal Investigators

  • Maxime Gilliaux, PhD student · Université Catholique de Louvain

  • Gaetan Stoquart, Professor · Université Catholique de Louvain

  • Christine Detrembleur, Professor · Université Catholique de Louvain

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-09
Primary Completion
2015-01-09
Completion
2017-10-02

Countries

  • Belgium

Study Locations

More Related Trials

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 NCT02079779 on ClinicalTrials.gov