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NOT YET RECRUITING
NCT06538506
PHASE2

ANIMATOR - RehUP BCI Controlled Robotic Therapy vs. an Attention-based Control

Sponsor: University of Calgary

View on ClinicalTrials.gov

Summary

ANIMATOR aims to examine how BCI therapy vs. attention based control therapy can be used to treat people in the chronic phase of stroke with moderate to severe upper extremity impairment. This interventional trial has two phases: Pilot (10 consecutive days of intervention) and a Randomized Phase (24 sessions over 8 weeks).

Official title: ANIMATOR - A Single-blind Randomized Controlled Trial of RehUP BCI Controlled Robotic Therapy vs. an Attention-based Control

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2024-08

Completion Date

2027-03

Last Updated

2024-08-09

Healthy Volunteers

No

Conditions

Interventions

DEVICE

RehUp BCI Intervention

Participants will be seated wearing a cap on their head containing surface electrodes connected to a computer/laptop. The laptop employs machine learning algorithms and uses the scalp electroencephalogram (EEG) signals from the scalp's surface to control a robotic arm which supports the patient's stroke-affected arm. The machine learning algorithms rapidly interpret EEG signals and adjust the outgoing movement commands to the robot based on an individual's responses to stimuli. The participant will be wearing a VR headset. The VR displays visual stimulus in time with the robotic arm. Based on information from the EEG, the participant is able to animate their robotic arm and receive visual task-based feedback in the VR.

OTHER

Control Therapy

The study therapist will focus on 3 activities (\~15 minutes each/session): passive range of motion exercises, motor imagery, and mirror therapy. These activities were chosen as they are all passive activities that are commonly used in a patient with severe impairment of the post-stroke arm and hand. Each session will last \~1hour including set up and switching between activities.

Locations (1)

Foothills Hospital

Calgary, Alberta, Canada