Control of Degrees of Freedom Post-stroke for the Recovery of the Upper Limb

NCT ID: NCT05371444

Last Updated: 2024-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2024-04-19

Brief Summary

The study's methodology will be a single-blind, multicenter, parallel-group randomized controlled trial (RCT). The sample consists of stroke patients (supratentorial ischemic and hemorrhagic stroke of anterior territory) between 18 and 80 years of age, separated into 2 groups of 20 participants. The experimental group called "controlled DoF", the control group 1 called "non controlled DoF". The "controlled DoF" group will use an exoskeleton that will restrict the movement of the trunk and upper limb to release only the joint to work in the plane of interest. The "non-controlled DoF" group will receive the same therapy time as the previous group but without any restriction of joint movements. The training will be functional with multiarticular and combined planes tasks. All groups receive the conventional rehabilitation of the health center (ideally 45 minutes 1 per day). Using motion sensors, clinical scales, and electroencephalography (EEG), the data will be obtained pre-intervention, post-intervention, and in a follow-up at 3 and 6 months.

Detailed Description

This proposal seeks to demonstrate if the control of joint degrees of freedom (DoF) of the trunk and upper limb is determinant during the early rehabilitation phase post-stroke (here from day 1 to day 28 or first month) for the recovery of upper limb movements without compensations and the normal brain control (true recovery).

The study's methodology will be a single-blind, multicenter, parallel-group randomized controlled trial (RCT). The sample consists of stroke patients (supratentorial ischemic and hemorrhagic stroke of anterior territory) between 18 and 80 years of age, separated into 2 groups of 20 participants. The experimental group called "controlled DoF", the control group 1 called "non controlled DoF". The "controlled DoF" group will receive for the initial 2 weeks, 2 hours of therapy, 5 times a week (2 sessions of 1 hour per day, 5 days) and the next 2 weeks, 2 hours of therapy, 3 times a week(2 sessions of 1 hour of therapy, 3 days), using an exoskeleton that will restrict the movement of the trunk and upper limb to release only the joint to work in the plane of interest. The training will be selective in an articulation plane with the biofeedback of active movements (or active-assisted) employing a video game controlled by an external movement sensor installed in the segment of interest. The "non-controlled DoF" group will receive the same therapy time as the previous group but without any restriction of joint movements. The training will be functional with multiarticular and combined planes tasks. All groups receive the conventional rehabilitation of the health center (ideally 45 minutes 1 per day). Using motion sensors, clinical scales, and electroencephalography (EEG), the data will be obtained pre-intervention, post-intervention, and in a follow-up at 3 and 6 months.

The expected results would show more functional improvements with less compensatory kinematics for therapy that control DoF than for the therapy without control of the DoF or for conventional therapy in acute post-stroke patients. About this result, the EEG connectivity analysis would show a lower interhemispheric inhibition of the motor areas and a greater frontal-parietal flow during reaching and manipulation tasks in the group with DoF control.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Controlled DoF

The treatment that this gruop will receive consist in a training with the exoskeleton that will restrict the DoF of the arm and trunk

Group Type: EXPERIMENTAL

Training with restriction of the DoF

Intervention Type: BEHAVIORAL

The intervention is based in the training of a single DoF of the upper extremity with restriction of the rest DoF of the arm and trunk that aren't being trained being restrained by an exoskeleton

Non controlled DoF

The treatment that this gruop will receive consist in a training with out the exoskeleton and without restriction of the DoF

Group Type: ACTIVE_COMPARATOR

Training without restriction of the DoF

Intervention Type: BEHAVIORAL

The intrevention is based in the training of the upper extremity movements without the restriction of DoF

Interventions

Training with restriction of the DoF

The intervention is based in the training of a single DoF of the upper extremity with restriction of the rest DoF of the arm and trunk that aren't being trained being restrained by an exoskeleton

Intervention Type: BEHAVIORAL

Training without restriction of the DoF

The intrevention is based in the training of the upper extremity movements without the restriction of DoF

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• (1) Clinical diagnosis of supratentorial ischemic stroke.
• (2) Time of onset <72 hours.
• (3) With alterations of the active voluntary movement of UL.
• (4) At least 3/8 DoF of the UE with MRC force scale of 3 or less.

Exclusion Criteria

• (1) Cognitive impairment that prevents signing informed consent, following instructions and understanding procedures. (MoCA ≥ 18).
• (2) Musculoskeletal pathologies that prevent activities without pain or with limited ranges for the scope.
• (3) Severe visual impairment that does not allow the activities associated with the task.
• (4) Cerebellar o brainstem stroke.
• (5) Previous stroke leaving upper limb impairment.
• (6) Bilateral sensorimotor alterations.
• (7) Do not present alterations in functional clinical tests.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fondo Nacional de Desarrollo Científico y Tecnológico, Chile

OTHER_GOV

Sponsor Role: collaborator

University of Chile

OTHER

Sponsor Role: lead

Responsible Party

Pablo Burgos

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pedro Maldonado, Doctor

Role: STUDY_CHAIR

University of Chile

Locations

Hospital Clínico Universidad de Chile

Santiago, , Chile

Countries

Chile

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

11181337

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

hcuch_038

Identifier Type: -

Identifier Source: org_study_id