ExoDoF: Robotic Exoskeleton for Upper Limb Motor Rehabilitation After Stroke
NCT Number: NCT06496529
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stroke
Interventions: BEHAVIORAL: DoF intervention|BEHAVIORAL: Task intervention
Sponsor: University of Chile
Collaborators: Agencia Nacional de Investigación y Desarrollo
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 44
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2025-05-31

Summary:
Two decades ago, the projection of recovery of the upper extremity (UE) after a stroke had a very poor prognosis worldwide. Nowadays, thanks to medical advances and early rehabilitation, the prognosis for recovery has improved; however, there is still a limit that no therapy has been able to overcome, related to spontaneous recovery as part of the natural evolution of the pathophysiological process, rather than with the contribution of rehabilitation. Additionally, existing therapies show partial effectiveness on the recovery of UE function, but do not avoid the use of compensatory strategies or alternatives to normal movement. Given this situation, there is an active search for new therapeutic approaches. In this clinical trial the investigators propose a rehabilitation paradigm that promotes the recovery of control of specific planes of movement through the selective restriction of degrees of freedom, simplifying control demands. The investigators sought to test the hypothesis that people with stroke in the early subacute stage and who present alterations in the movement of the upper extremity, a rehabilitation protocol that reduces the degrees of freedom of the UE and trunk, enables greater recovery of the movement of the UE and less use of compensatory movements compared to a protocol without DoF control. The general objective is to demonstrate the effect of training with restriction of the degrees of freedom of UE and trunk, mediated by an exoskeleton and videogames, on the control of the UE.

Primary Outcome Measures: Change in UE-FMA at the end of the training, Differences between the Upper Extremity Fugl-Meyer Assessment (UE-FMA) at the beginning of the recruitment and at the end of the training, 3 days post training|Change in UE-FMA at 90 days post training, Differences between the Upper Extremity Fugl-Meyer Assessment (UE-FMA) at the beginning of the recruitment and at 90 days post training, 90 days post training|Change in UE-FMA at 6 months post stroke, Differences between the Upper Extremity Fugl-Meyer Assessment (UE-FMA) at the beginning of the recruitment and at 6 months post stroke, 180 days post stroke
Secondary Outcome Measures: Change in ARAT at the end of the training, Differences between the Action Research Arm Test (ARAT) at the beginning of the recruitment and at the end of the training, 3 days post training|Change in ARAT at 90 days post training, Differences between the Action Research Arm Test (ARAT) at the beginning of the recruitment and at 90 days post training, 90 days post training|Change in ARAT at 6 months post stroke, Differences between the Action Research Arm Test (ARAT) at the beginning of the recruitment and at 6 months post stroke, 180 days post stroke|Change in iCoh at the end of the training, Differences between EEG Ipsi-Contralateral Motor Cortex connectivity (iCoh) at the beginning of the training and at the end of the training, 3 days post training|Change in iCoh at 90 days post training, Differences between EEG Ipsi-Contralateral Motor Cortex connectivity (iCoh) at the beginning of the training and at 90 days post training, 90 days post training|Change in iCoh connectivity at 6 months post stroke, Differences between EEG Ipsi-Contralateral Motor Cortex connectivity (iCoh) at the beginning of the training and at 6 months post stroke, 180 days post stroke|Change in arm kinematics at the end of the training, Differences between arm kinematics (shoulder, elbow, wrist and finger angles during reaching and grasping a glass) at the beginning of the training and at the end of the training, 3 days post training|Change in arm kinematics at 90 days post training, Differences between arm kinematics (shoulder, elbow, wrist and finger angles during reaching and grasping a glass) at the beginning of the training and at 90 days post training, 90 days post training|Change in arm kinematics at 6 months post stroke, Differences between arm kinematics (shoulder, elbow, wrist and finger angles during reaching and grasping a glass) at the beginning of the training and at 6 months post stroke, 180 days post stroke