Control of Degrees of Freedom Post-stroke for the Recovery of the Upper Limb (DoF_UL_S)
Primary Purpose
Stroke
Status
Recruiting
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Training with restriction of the DoF
Training without restriction of the DoF
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring True recovery, Neurorehabilitation, Stroke
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.
Sites / Locations
- Hospital Clínico Universidad de ChileRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
Controlled DoF
Non controlled DoF
Conventional
Arm Description
The treatment that this gruop will receive consist in a training with the exoskeleton that will restrict the DoF of the arm and trunk
The treatment that this gruop will receive consist in a training with out the exoskeleton and without restriction of the DoF
This group will only recieve the conventional therapy that is given by the medical center
Outcomes
Primary Outcome Measures
Normal movements Outcome. Kinematics of grasping and reaching 1
Joint angles of the upper extremity in a water glass test
Normal movements Outcome. Kinematics of grasping and reaching 2
Joint angles of the upper extremity in a water glass test
Normal movements Outcome. Kinematics of grasping and reaching 3
Joint angles of the upper extremity in a water glass test
Normal movements Outcome. Kinematics of grasping and reaching 4
Joint angles of the upper extremity in a glass test
Functioning Outcome 1
Scale scores of Fugl Meyer Upper Limb test
Functioning Outcome 2
Scale scores of Fugl Meyer Upper Limb test
Functioning Outcome 3
Scale scores of Fugl Meyer Upper Limb test
Functioning Outcome 4
Scale scores of Fugl Meyer Upper Limb test
Functioning Outcome - function of the arm1
Scale scores of ARAT (Action Research Arm Test)
Functioning Outcome - function of the arm 2
Scale scores of ARAT (Action Research Arm Test)
Functioning Outcome - function of the arm 3
Scale scores of ARAT (Action Research Arm Test)
Functioning Outcome - function of the arm 4
Scale scores of ARAT (Action Research Arm Test)
Functioning Outcome - daily life activities 1
Scale scores of Barthel Index (independence in daily life activities)
Functioning Outcome - daily life activities 2
Scale scores of Barthel Index (independence in daily life activities)
Functioning Outcome - daily life activities 3
Scale scores of Barthel Index (independence in daily life activities)
Functioning Outcome - daily life activities 4
Scale scores of Barthel Index (independence in daily life activities)
Functioning Outcome - quality of life 1
Scale scores of EQ-5D (quality of life test)
Functioning Outcome - quality of life 2
Scale scores of EQ-5D (quality of life test)
Functioning Outcome - quality of life 3
Scale scores of EQ-5D (quality of life test)
Functioning Outcome - quality of life 4
Scale scores of EQ-5D (quality of life test)
Connectivity Outcome 1
Interhermispheric coherence of beta bands in the EEG.
Connectivity Outcome 2
Interhermispheric coherence of beta bands in the EEG.
Connectivity Outcome 3
Interhermispheric coherence of beta bands in the EEG.
Connectivity Outcome 4
Interhermispheric coherence of beta bands in the EEG.
Secondary Outcome Measures
Full Information
NCT ID
NCT05371444
First Posted
April 26, 2021
Last Updated
November 14, 2022
Sponsor
University of Chile
Collaborators
Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
1. Study Identification
Unique Protocol Identification Number
NCT05371444
Brief Title
Control of Degrees of Freedom Post-stroke for the Recovery of the Upper Limb
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
February 1, 2023 (Anticipated)
Study Completion Date
April 10, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Chile
Collaborators
Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 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.
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
True recovery, Neurorehabilitation, Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The outcomes assessors will not now the arm to which each participant corresponds
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Controlled DoF
Arm Type
Experimental
Arm Description
The treatment that this gruop will receive consist in a training with the exoskeleton that will restrict the DoF of the arm and trunk
Arm Title
Non controlled DoF
Arm Type
Active Comparator
Arm Description
The treatment that this gruop will receive consist in a training with out the exoskeleton and without restriction of the DoF
Arm Title
Conventional
Arm Type
No Intervention
Arm Description
This group will only recieve the conventional therapy that is given by the medical center
Intervention Type
Behavioral
Intervention Name(s)
Training with restriction of the DoF
Intervention Description
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
Intervention Name(s)
Training without restriction of the DoF
Intervention Description
The intrevention is based in the training of the upper extremity movements without the restriction of DoF
Primary Outcome Measure Information:
Title
Normal movements Outcome. Kinematics of grasping and reaching 1
Description
Joint angles of the upper extremity in a water glass test
Time Frame
At week 1
Title
Normal movements Outcome. Kinematics of grasping and reaching 2
Description
Joint angles of the upper extremity in a water glass test
Time Frame
At week 5
Title
Normal movements Outcome. Kinematics of grasping and reaching 3
Description
Joint angles of the upper extremity in a water glass test
Time Frame
At week 12
Title
Normal movements Outcome. Kinematics of grasping and reaching 4
Description
Joint angles of the upper extremity in a glass test
Time Frame
At week 24
Title
Functioning Outcome 1
Description
Scale scores of Fugl Meyer Upper Limb test
Time Frame
At week 1
Title
Functioning Outcome 2
Description
Scale scores of Fugl Meyer Upper Limb test
Time Frame
At week 5
Title
Functioning Outcome 3
Description
Scale scores of Fugl Meyer Upper Limb test
Time Frame
At week 12
Title
Functioning Outcome 4
Description
Scale scores of Fugl Meyer Upper Limb test
Time Frame
At week 24
Title
Functioning Outcome - function of the arm1
Description
Scale scores of ARAT (Action Research Arm Test)
Time Frame
At week 1
Title
Functioning Outcome - function of the arm 2
Description
Scale scores of ARAT (Action Research Arm Test)
Time Frame
At week 5
Title
Functioning Outcome - function of the arm 3
Description
Scale scores of ARAT (Action Research Arm Test)
Time Frame
At week 12
Title
Functioning Outcome - function of the arm 4
Description
Scale scores of ARAT (Action Research Arm Test)
Time Frame
At week 24
Title
Functioning Outcome - daily life activities 1
Description
Scale scores of Barthel Index (independence in daily life activities)
Time Frame
At week 1
Title
Functioning Outcome - daily life activities 2
Description
Scale scores of Barthel Index (independence in daily life activities)
Time Frame
At week 5
Title
Functioning Outcome - daily life activities 3
Description
Scale scores of Barthel Index (independence in daily life activities)
Time Frame
At week 12
Title
Functioning Outcome - daily life activities 4
Description
Scale scores of Barthel Index (independence in daily life activities)
Time Frame
At week 24
Title
Functioning Outcome - quality of life 1
Description
Scale scores of EQ-5D (quality of life test)
Time Frame
At week 1
Title
Functioning Outcome - quality of life 2
Description
Scale scores of EQ-5D (quality of life test)
Time Frame
At week 5
Title
Functioning Outcome - quality of life 3
Description
Scale scores of EQ-5D (quality of life test)
Time Frame
At week 12
Title
Functioning Outcome - quality of life 4
Description
Scale scores of EQ-5D (quality of life test)
Time Frame
At week 24
Title
Connectivity Outcome 1
Description
Interhermispheric coherence of beta bands in the EEG.
Time Frame
At week 1
Title
Connectivity Outcome 2
Description
Interhermispheric coherence of beta bands in the EEG.
Time Frame
At week 5
Title
Connectivity Outcome 3
Description
Interhermispheric coherence of beta bands in the EEG.
Time Frame
At week 12
Title
Connectivity Outcome 4
Description
Interhermispheric coherence of beta bands in the EEG.
Time Frame
At week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Burgos
Phone
+56979782534
Email
pburgos@uchile.cl
First Name & Middle Initial & Last Name or Official Title & Degree
María Rodriguez
Phone
+56982262530
Email
mloreto.rodriguez@uchile.cl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pedro Maldonado, Doctor
Organizational Affiliation
University of Chile
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital Clínico Universidad de Chile
City
Santiago
ZIP/Postal Code
8320000
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fernanda Aleitte, MsC
Phone
+56987493594
Email
feraleitte@uchile.cl
First Name & Middle Initial & Last Name & Degree
Trinidad Bruna, MsC
Phone
+56933798305
Email
t_bruna@uchile.cl
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Control of Degrees of Freedom Post-stroke for the Recovery of the Upper Limb
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