ExoDoF: Robotic Exoskeleton for Upper Limb Motor Rehabilitation After Stroke

Not Applicable

Not yet recruiting

• Conditions: Stroke

• Registration Number: NCT06496529
• Lead Sponsor: University of Chile

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-03
• Study First Submitted QC: 2024-07-03
• Study First Posted: 2024-07-11
• Last Update Submitted: 2024-07-15
• Last Update Posted: 2024-07-17
• Study Start: 2024-08-01
• Primary Completion: 2025-05-31
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• Diagnosis of ischemic or hemorrhagic stroke with zero to six weeks of evolution.
• Subjects with alterations in active voluntary movement of ES with Fugl Meyer less than or equal to 50 points. Strength of shoulder abduction or finger extension from palpable contraction (1 in Medical Research Council (MRC) scale for muscle strength).

Exclusion Criteria

• Cognitive impairment that prevents signing the informed consent, following the instructions and understanding the procedures. (MOCA < 18).
• Inability to perform activities sitting for more than 90 minutes or inability to perform activities without severe pain (VAS > 6) or having limited reach ranges.
• Have severe visual impairment that does not allow to carry out the activities associated with the task.
• Previous stroke with neurological sequelae in the upper extremity.
• Present bilateral sensorimotor alterations.
• Damage to the cerebellum/peduncles described in the radiological report or classic signs of cerebellar damage (Upper extremity SARA items of 2 or more)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in UE-FMA at the end of the training	3 days post training	Differences between the Upper Extremity Fugl-Meyer Assessment (UE-FMA) at the beginning of the recruitment and at the end of the training
Change in UE-FMA at 90 days post training	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
Change in UE-FMA at 6 months post stroke	180 days post stroke	Differences between the Upper Extremity Fugl-Meyer Assessment (UE-FMA) at the beginning of the recruitment and at 6 months post stroke

Secondary Outcome Measures

Name	Time	Method
Change in ARAT at 90 days post training	90 days post training	Differences between the Action Research Arm Test (ARAT) at the beginning of the recruitment and at 90 days post training
Change in ARAT at 6 months post stroke	180 days post stroke	Differences between the Action Research Arm Test (ARAT) at the beginning of the recruitment and at 6 months post stroke
Change in iCoh at the end of the training	3 days post training	Differences between EEG Ipsi-Contralateral Motor Cortex connectivity (iCoh) at the beginning of the training and at the end of the training
Change in iCoh at 90 days post training	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
Change in ARAT at the end of the training	3 days post training	Differences between the Action Research Arm Test (ARAT) at the beginning of the recruitment and at the end of the training
Change in arm kinematics at 6 months post stroke	180 days 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
Change in arm kinematics at the end of the training	3 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 the end of the training
Change in arm kinematics at 90 days post training	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
Change in iCoh connectivity at 6 months post stroke	180 days post stroke	Differences between EEG Ipsi-Contralateral Motor Cortex connectivity (iCoh) at the beginning of the training and at 6 months post stroke