Clinical trial NCT03508037: Therapy to Improve Reaching Movement in Upper Limb
Official title: Hybrid Robotic System and EEG Based on an Adaptative and Associative Assistance for Rehabilitation of Reaching Movements After Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Impairment Upper Limb
Lead sponsor: Cajal Institute of the Spanish National Research Council
Sponsor class: OTHER
Collaborators: name: Centro de Referencia Estatal de Atención Al Daño Cerebral
name: Centro Universitario La Salle
First posted: 2018-04-25
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Strokes are caused by a bleed in the brain and can be life threatening. One common consequence is upper limb impairment. This causes stroke patients to be unable to use their arms and upper body to do simple tasks such as reaching or grasping. Currently, people with stroke undergo rehabilitation, which is usually done through a physical and occupational (daily living skills) therapies to improve their mobility (movement) with their upper limbs. However, this kind of treatment has limitations and often cannot help patients regain total mobility. There are alternative rehabilitation treatments that use new methods and technologies that may be able to help patients with stroke. Neuromodulaton therapies using brain-computer interfaces (BCI), which connects brain signals directly to a computer, have the potential to help patients. This type of therapy uses assistive devices such as electrical stimulation (electrical shocks or waves) and robots to help restore function to the areas affected by stroke. The aim of this study is to evaluate and the potential benefits that can be achieved by using assistive devices in rehabilitation sessions with stroke patients.


Eligibility criteria: Inclusion Criteria:

* With response to Transcranial Magnetic Stimulation (TMS)
* Cortical or sub-cortical stroke patients
* With a score in the range of 22-44 on Fugl-Meyer scale or 2-4 on the Motor Assessment Scale
* With visible cortical patterns registered by BCI
* Subjects that tolerate electrical stimulation and that present a motor response
* Subjects with cognitive ability to follow instructions and perform the indicated tasks

Exclusion Criteria:

* Subjects with neurological injury prior to stroke or more than two events
* Patients with implanted devices
* Patients with severe motor paralysis
* Patients with epilepsy
* Patient with vision or hearing impairment

Primary outcomes:
measure: Changes in muscular balance's of upper limb
timeFrame: One week before the intervention. One week after the intervention. One month after the intervention. (The duration of the intervention is three weeks).
measure: Changes in modified scale of Answorth
timeFrame: One week before the intervention. One week after the intervention. One month after the intervention.
measure: Changes in FIM
timeFrame: One week before the intervention. One week after the intervention. One month after the intervention.
measure: Changes in Quick Dash
timeFrame: One week before the intervention. One week after the intervention. One month after the intervention.
measure: Changes in Action Research Arm Test (ARAT)
timeFrame: One week before the intervention. One week after the intervention. One month after the intervention.
measure: Changes in Quebec User Evaluation of Satisfaction with Assistive Technology (QTEST)
timeFrame: One week before the intervention. One week after the intervention. One month after the intervention.
measure: Changes in the Self-Assessment Manikin (SAM)
timeFrame: One week before the intervention. One week after the intervention. One month after the intervention.
measure: Changes in isometric force
timeFrame: One week before the intervention. One week after the intervention. One month after the intervention.
measure: Changes in range of movement
timeFrame: One week before the intervention. One week after the intervention. One month after the intervention.
measure: Changes in Lawton & Brody
timeFrame: One week before the intervention. One week after the intervention. One month after the intervention.
measure: Changes in Box and Block
timeFrame: One week before the intervention. One week after the intervention. One month after the intervention.
measure: Changes in System Usability Scale (SUS)
timeFrame: One week before the intervention. One week after the intervention. One month after the intervention.
Secondary outcomes:
measure: Changes in Motor Evoked Potentials (MEPs).
timeFrame: One week before the intervention. One week after the intervention. One month after the intervention.
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Centro de Referencia Estatal de Atención al Daño Cerebral (CEADAC)
Study officials:
affiliation: Centro Superior de Investigaciones Científicas (CSIC)
name: Jose Luis Pons
role: PRINCIPAL_INVESTIGATOR
References: