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

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

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Behavioral: Training with restriction of the DoF; Behavioral: Training without restriction of the DoF

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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Chile
  • Santiago, Chile, 8320000
    • Hospital Clínico Universidad de Chile

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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
Active Comparator: Non controlled DoF; The treatment that this gruop will receive consist in a training with out the exoskeleton and without restriction of the DoF	Behavioral: Training without restriction of the DoF; The intrevention is based in the training of the upper extremity movements without the restriction of DoF

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Chile
• Collaborators: Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
• Investigators: Study Chair: Pedro Maldonado, Doctor, University of Chile

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Actual): April 19, 2024
• Study Completion (Actual): April 19, 2024

Study Registration Dates

• First Submitted: April 26, 2021
• First Submitted That Met QC Criteria: May 7, 2022
• First Posted (Actual): May 12, 2022

Study Record Updates

• Last Update Posted (Actual): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Stroke; Neurorehabilitation; True recovery
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: hcuch_038; 11181337 (Other Grant/Funding Number: Fondecyt ANID)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No