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

Stroke Clinical Trial

— DoF_UL_S  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05371444
• Other study ID #: hcuch_038
• Secondary ID: 11181337
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: April 10, 2023

Study information

• Verified date: November 2022
• Source: University of Chile
• Contact: Burgos
• Phone: +56979782534
• Email: pburgos[@]uchile.cl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 3 groups of 20 participants. The experimental group called "controlled DoF", the control group 1 called "non controlled DoF" and the control group 2 called "Conventional". 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) and the "Conventional" group receives only this intervention. 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.

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 3 groups of 20 participants. The experimental group called "controlled DoF", the control group 1 called "non controlled DoF" and the control group 2 called "Conventional". 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) and the "Conventional" group only receives this intervention. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 10, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• 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
• Training without restriction of the DoF
The intrevention is based in the training of the upper extremity movements without the restriction of DoF

Locations

Country	Name	City	State
Chile	Hospital Clínico Universidad de Chile	Santiago

Sponsors (2)

Lead Sponsor	Collaborator
University of Chile	Fondo Nacional de Desarrollo Científico y Tecnológico, Chile

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Normal movements Outcome. Kinematics of grasping and reaching 1	Joint angles of the upper extremity in a water glass test	At week 1
Primary	Normal movements Outcome. Kinematics of grasping and reaching 2	Joint angles of the upper extremity in a water glass test	At week 5
Primary	Normal movements Outcome. Kinematics of grasping and reaching 3	Joint angles of the upper extremity in a water glass test	At week 12
Primary	Normal movements Outcome. Kinematics of grasping and reaching 4	Joint angles of the upper extremity in a glass test	At week 24
Primary	Functioning Outcome 1	Scale scores of Fugl Meyer Upper Limb test	At week 1
Primary	Functioning Outcome 2	Scale scores of Fugl Meyer Upper Limb test	At week 5
Primary	Functioning Outcome 3	Scale scores of Fugl Meyer Upper Limb test	At week 12
Primary	Functioning Outcome 4	Scale scores of Fugl Meyer Upper Limb test	At week 24
Primary	Functioning Outcome - function of the arm1	Scale scores of ARAT (Action Research Arm Test)	At week 1
Primary	Functioning Outcome - function of the arm 2	Scale scores of ARAT (Action Research Arm Test)	At week 5
Primary	Functioning Outcome - function of the arm 3	Scale scores of ARAT (Action Research Arm Test)	At week 12
Primary	Functioning Outcome - function of the arm 4	Scale scores of ARAT (Action Research Arm Test)	At week 24
Primary	Functioning Outcome - daily life activities 1	Scale scores of Barthel Index (independence in daily life activities)	At week 1
Primary	Functioning Outcome - daily life activities 2	Scale scores of Barthel Index (independence in daily life activities)	At week 5
Primary	Functioning Outcome - daily life activities 3	Scale scores of Barthel Index (independence in daily life activities)	At week 12
Primary	Functioning Outcome - daily life activities 4	Scale scores of Barthel Index (independence in daily life activities)	At week 24
Primary	Functioning Outcome - quality of life 1	Scale scores of EQ-5D (quality of life test)	At week 1
Primary	Functioning Outcome - quality of life 2	Scale scores of EQ-5D (quality of life test)	At week 5
Primary	Functioning Outcome - quality of life 3	Scale scores of EQ-5D (quality of life test)	At week 12
Primary	Functioning Outcome - quality of life 4	Scale scores of EQ-5D (quality of life test)	At week 24
Primary	Connectivity Outcome 1	Interhermispheric coherence of beta bands in the EEG.	At week 1
Primary	Connectivity Outcome 2	Interhermispheric coherence of beta bands in the EEG.	At week 5
Primary	Connectivity Outcome 3	Interhermispheric coherence of beta bands in the EEG.	At week 12
Primary	Connectivity Outcome 4	Interhermispheric coherence of beta bands in the EEG.	At week 24