StrokeDoF_UL_SNCT05371444
Control of Degrees of Freedom Post-stroke for the Recovery of the Upper Limb
A study testing Training with restriction of the DoF and Training without restriction of the DoF in people with Stroke, run by University of Chile at 1 site in Chile.
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 2 groups of 20 participants. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Training with restriction of the DoF and Training without restriction of the DoF
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChile
- Study dates
- 1 Apr 2021to 19 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- (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.
Who cannot join
- (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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Training with restriction of the DoF, Training without restriction of the DoF
- Keywords
- True recovery, Neurorehabilitation, Stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training with restriction of the DoFBehavioural
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 DoFBehavioural
The intrevention is based in the training of the upper extremity movements without the restriction of DoF
| Study group | Role | What they receive |
|---|---|---|
| Controlled DoF | Experimental | The treatment that this gruop will receive consist in a training with the exoskeleton that will restrict the DoF of the arm and trunk Receives: Behavioral: Training with restriction of the DoF |
| Non controlled DoF | Active comparator | The treatment that this gruop will receive consist in a training with out the exoskeleton and without restriction of the DoF Receives: Behavioral: Training without restriction of the DoF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Normal movements Outcome. Kinematics of grasping and reaching 1
Joint angles of the upper extremity in a water glass test
Measured: At week 1
Normal movements Outcome. Kinematics of grasping and reaching 2
Joint angles of the upper extremity in a water glass test
Measured: At week 5
Normal movements Outcome. Kinematics of grasping and reaching 3
Joint angles of the upper extremity in a water glass test
Measured: At week 12
Normal movements Outcome. Kinematics of grasping and reaching 4
Joint angles of the upper extremity in a glass test
Measured: At week 24
Functioning Outcome 1
Scale scores of Fugl Meyer Upper Limb test
Measured: At week 1
Functioning Outcome 2
Scale scores of Fugl Meyer Upper Limb test
Measured: At week 5
Functioning Outcome 3
Scale scores of Fugl Meyer Upper Limb test
Measured: At week 12
Functioning Outcome 4
Scale scores of Fugl Meyer Upper Limb test
Measured: At week 24
Functioning Outcome - function of the arm1
Scale scores of ARAT (Action Research Arm Test)
Measured: At week 1
Functioning Outcome - function of the arm 2
Scale scores of ARAT (Action Research Arm Test)
Measured: At week 5
Functioning Outcome - function of the arm 3
Scale scores of ARAT (Action Research Arm Test)
Measured: At week 12
Functioning Outcome - function of the arm 4
Scale scores of ARAT (Action Research Arm Test)
Measured: At week 24
Functioning Outcome - daily life activities 1
Scale scores of Barthel Index (independence in daily life activities)
Measured: At week 1
Functioning Outcome - daily life activities 2
Scale scores of Barthel Index (independence in daily life activities)
Measured: At week 5
Functioning Outcome - daily life activities 3
Scale scores of Barthel Index (independence in daily life activities)
Measured: At week 12
Functioning Outcome - daily life activities 4
Scale scores of Barthel Index (independence in daily life activities)
Measured: At week 24
Functioning Outcome - quality of life 1
Scale scores of EQ-5D (quality of life test)
Measured: At week 1
Functioning Outcome - quality of life 2
Scale scores of EQ-5D (quality of life test)
Measured: At week 5
Functioning Outcome - quality of life 3
Scale scores of EQ-5D (quality of life test)
Measured: At week 12
Functioning Outcome - quality of life 4
Scale scores of EQ-5D (quality of life test)
Measured: At week 24
Connectivity Outcome 1
Interhermispheric coherence of beta bands in the EEG.
Measured: At week 1
Connectivity Outcome 2
Interhermispheric coherence of beta bands in the EEG.
Measured: At week 5
Connectivity Outcome 3
Interhermispheric coherence of beta bands in the EEG.
Measured: At week 12
Connectivity Outcome 4
Interhermispheric coherence of beta bands in the EEG.
Measured: At week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start1 Apr 2021
- Primary completion19 Apr 2024
- Study completion19 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
- Responsible party
- Principal investigator, Pablo Burgos, University of Chile
- Investigators
- Pedro Maldonado, Doctor, Study chair, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05371444
- Sponsor's protocol ID
- hcuch_038
- Other IDs
- 11181337
- Acronym
- DoF_UL_S
- Status last verified
- Apr 2024
- First submitted
- 26 Apr 2021
- Last updated
- 26 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05371444
- Acronym / sponsor ID
- DoF_UL_S / hcuch_038
- Conditions
- Stroke
- Keywords
- True recovery, Neurorehabilitation, Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Collaborators
- Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 19 Apr 2024 (actual)
- Study completion
- 19 Apr 2024 (actual)
- First posted
- 12 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Controlled DoF | Experimental | Behavioral: Training with restriction of the DoFThe treatment that this gruop will receive consist in a training with the exoskeleton that will restrict the DoF of the arm and trunk |
| Non controlled DoF | Active comparator | Behavioral: Training without restriction of the DoFThe treatment that this gruop will receive consist in a training with out the exoskeleton and without restriction of the DoF |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- (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.
Key exclusion criteria (7 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Training with restriction of the DoFThe 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 | Behavioural | Controlled DoF |
| Training without restriction of the DoFThe intrevention is based in the training of the upper extremity movements without the restriction of DoF | Behavioural | Non controlled DoF |
Primary outcome
Normal movements Outcome. Kinematics of grasping and reaching 1
Time frame: At week 1
Joint angles of the upper extremity in a water glass test
Normal movements Outcome. Kinematics of grasping and reaching 2
Time frame: At week 5
Joint angles of the upper extremity in a water glass test
Normal movements Outcome. Kinematics of grasping and reaching 3
Time frame: At week 12
Joint angles of the upper extremity in a water glass test
Normal movements Outcome. Kinematics of grasping and reaching 4
Time frame: At week 24
Joint angles of the upper extremity in a glass test
Functioning Outcome 1
Time frame: At week 1
Scale scores of Fugl Meyer Upper Limb test
Functioning Outcome 2
Time frame: At week 5
Scale scores of Fugl Meyer Upper Limb test
Functioning Outcome 3
Time frame: At week 12
Scale scores of Fugl Meyer Upper Limb test
Functioning Outcome 4
Time frame: At week 24
Scale scores of Fugl Meyer Upper Limb test
Functioning Outcome - function of the arm1
Time frame: At week 1
Scale scores of ARAT (Action Research Arm Test)
Functioning Outcome - function of the arm 2
Time frame: At week 5
Scale scores of ARAT (Action Research Arm Test)
Functioning Outcome - function of the arm 3
Time frame: At week 12
Scale scores of ARAT (Action Research Arm Test)
Functioning Outcome - function of the arm 4
Time frame: At week 24
Scale scores of ARAT (Action Research Arm Test)
Functioning Outcome - daily life activities 1
Time frame: At week 1
Scale scores of Barthel Index (independence in daily life activities)
Functioning Outcome - daily life activities 2
Time frame: At week 5
Scale scores of Barthel Index (independence in daily life activities)
Functioning Outcome - daily life activities 3
Time frame: At week 12
Scale scores of Barthel Index (independence in daily life activities)
Functioning Outcome - daily life activities 4
Time frame: At week 24
Scale scores of Barthel Index (independence in daily life activities)
Functioning Outcome - quality of life 1
Time frame: At week 1
Scale scores of EQ-5D (quality of life test)
Functioning Outcome - quality of life 2
Time frame: At week 5
Scale scores of EQ-5D (quality of life test)
Functioning Outcome - quality of life 3
Time frame: At week 12
Scale scores of EQ-5D (quality of life test)
Functioning Outcome - quality of life 4
Time frame: At week 24
Scale scores of EQ-5D (quality of life test)
Connectivity Outcome 1
Time frame: At week 1
Interhermispheric coherence of beta bands in the EEG.
Connectivity Outcome 2
Time frame: At week 5
Interhermispheric coherence of beta bands in the EEG.
Connectivity Outcome 3
Time frame: At week 12
Interhermispheric coherence of beta bands in the EEG.
Connectivity Outcome 4
Time frame: At week 24
Interhermispheric coherence of beta bands in the EEG.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
- Individual participant dataSharing planned: Yes
Related trials for Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pedro Maldonado, Doctor study chair
University of Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training with restriction of the DoF and Training without restriction of the DoF in people with Stroke, run by University of Chile at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Normal movements Outcome. Kinematics of grasping and reaching 1 (time frame: At week 1). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2024.