Clinical trial NCT05371444: Control of Degrees of Freedom Post-stroke for the Recovery of the Upper Limb
Official title: Effects of Control of Joint Degrees of Freedom in the Early Rehabilitation Post-stroke for the Recovery of Normal Movement (Non-compensatory) of the Upper Limb
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: True recovery
Neurorehabilitation
Stroke
Lead sponsor: University of Chile
Sponsor class: OTHER
Collaborators: name: Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
First posted: 2022-05-12
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Normal movements Outcome. Kinematics of grasping and reaching 1
timeFrame: At week 1
measure: Normal movements Outcome. Kinematics of grasping and reaching 2
timeFrame: At week 5
measure: Normal movements Outcome. Kinematics of grasping and reaching 3
timeFrame: At week 12
measure: Normal movements Outcome. Kinematics of grasping and reaching 4
timeFrame: At week 24
measure: Functioning Outcome 1
timeFrame: At week 1
measure: Functioning Outcome 2
timeFrame: At week 5
measure: Functioning Outcome 3
timeFrame: At week 12
measure: Functioning Outcome 4
timeFrame: At week 24
measure: Functioning Outcome - function of the arm1
timeFrame: At week 1
measure: Functioning Outcome - function of the arm 2
timeFrame: At week 5
measure: Functioning Outcome - function of the arm 3
timeFrame: At week 12
measure: Functioning Outcome - function of the arm 4
timeFrame: At week 24
measure: Functioning Outcome - daily life activities 1
timeFrame: At week 1
measure: Functioning Outcome - daily life activities 2
timeFrame: At week 5
measure: Functioning Outcome - daily life activities 3
timeFrame: At week 12
measure: Functioning Outcome - daily life activities 4
timeFrame: At week 24
measure: Functioning Outcome - quality of life 1
timeFrame: At week 1
measure: Functioning Outcome - quality of life 2
timeFrame: At week 5
measure: Functioning Outcome - quality of life 3
timeFrame: At week 12
measure: Functioning Outcome - quality of life 4
timeFrame: At week 24
measure: Connectivity Outcome 1
timeFrame: At week 1
measure: Connectivity Outcome 2
timeFrame: At week 5
measure: Connectivity Outcome 3
timeFrame: At week 12
measure: Connectivity Outcome 4
timeFrame: At week 24
Secondary outcomes:
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Hospital Clínico Universidad de Chile
Study officials:
affiliation: University of Chile
name: Pedro Maldonado, Doctor
role: STUDY_CHAIR
References: