StrokeNCT06496529
ExoDoF: Robotic Exoskeleton for Upper Limb Motor Rehabilitation After Stroke
A study testing DoF intervention and Task intervention in people with Stroke, run by University of Chile at 4 sites in Chile.
Trial summary
Two decades ago, the projection of recovery of the upper extremity (UE) after a stroke had a very poor prognosis worldwide. Nowadays, thanks to medical advances and early rehabilitation, the prognosis for recovery has improved; however, there is still a limit that no therapy has been able to overcome, related to… Read more about this study
- Who is it for?
- Ages 18 to 81 years
- Conditions the study is for
- Stroke
- What is being tested?
- DoF intervention and Task intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 4 sitesChile
- Study dates
- 1 Mar 2025to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 81 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of ischemic or hemorrhagic stroke with zero to twelve weeks of evolution.
- Subjects with alterations in active voluntary movement of ES with Fugl Meyer less than or equal to 50 points. Strength of shoulder abduction and finger extension from palpable contraction (1 in Medical Research Council (MRC) scale for muscle strength).
Who cannot join
- Cognitive impairment that prevents signing the informed consent, following the instructions and understanding the procedures. (MOCA < 18).
- Inability to perform activities sitting for more than 90 minutes or inability to perform activities without severe pain (VAS > 6) or having limited reach ranges.
- Have severe visual impairment that does not allow to carry out the activities associated with the task.
- Previous stroke with neurological sequelae in the upper extremity.
- Present bilateral sensorimotor alterations.
- Damage to the cerebellum/peduncles described in the radiological report or classic signs of cerebellar damage (Upper extremity SARA items of 2 or more)
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Chile4 sites, 4 recruiting
- Recruiting
Hospital Clínico Universidad de Chile
Santiago
Hachi Manzur, Ph.D, +56 9 8192 8168, hemanzur@gmail.com
- Recruiting
Hospital El Carmen
Santiago
Daniel Bustos, PT, +56 9 7754 9193, daniel.bustos.c@usach.cl
- Recruiting
Hospital San José
Santiago
Natalia Gonzalez, PT, +56 9 8154 8009, nataliagonzaleznunes@gmail.com
- Recruiting
Hospital Dr. Hernán Henríquez Aravena
Temuco
Pablo Hernández, PT, +56 9 7853 9892, klgo.pablohernandez@gmail.com
About this study
Two decades ago, the projection of recovery of the upper extremity (UE) after a stroke had a very poor prognosis worldwide. Nowadays, thanks to medical advances and early rehabilitation, the prognosis for recovery has improved; however, there is still a limit that no therapy has been able to overcome, related to spontaneous recovery as part of the natural evolution of the pathophysiological process, rather than with the contribution of rehabilitation. Additionally, existing therapies show partial effectiveness on the recovery of UE function, but do not avoid the use of compensatory strategies or alternatives to normal movement. Given this situation, there is an active search for new therapeutic approaches. In this clinical trial the investigators propose a rehabilitation paradigm that promotes the recovery of control of specific planes of movement through the selective restriction of degrees of freedom, simplifying control demands. The investigators sought to test the hypothesis that people with stroke in the early subacute stage and who present alterations in the movement of the upper extremity, a rehabilitation protocol that reduces the degrees of freedom of the UE and trunk, enables greater recovery of the movement of the UE and less use of compensatory movements compared to a protocol without DoF control. The general objective is to demonstrate the effect of training with restriction of the degrees of freedom of UE and trunk, mediated by an exoskeleton and videogames, on the control of the UE.
- Conditions
- Stroke
- Being tested
- DoF intervention, Task intervention
- Keywords
- stroke recovery, motor recovery, upper extremity recovery
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoF interventionBehavioural
Training of specific uniarticular and single plane movement of the upper limb through an exoskeleton and videogames that will be supervised by a physiotherapist.
Task interventionBehavioural
Training of multiarticular upper limb movements (vertical, horizontal and diagonal) through videogames and also training of functional task (raise and lower your hand on the table, cleaning a table, put cream on the non-paretic arm, hold a bottle, put a piece of bread or something similar in your mouth, wash your face, brush your hair, store items in a basket, brush teeth, wrote and serve water in glass). This activities will be supervised by a physiotherapist.
| Study group | Role | What they receive |
|---|---|---|
| DoF Group | Experimental | The experimental group with control of the degrees of freedom will receive treatment for 4 weeks using an exoskeleton and also it will be supervised by a physiotherapist.The exoskeleton will restrict the movement of the trunk and upper extremity to leave only the joint free to work in the plane of interest. The training will be selective in an articular plane with biofeedback of movement through videogames and external movement sensors installed in the upper extremity. This movement sensor will allow to interact with the videogames through the movement of the trained movement. Receives: Behavioral: DoF intervention |
| Task Group | Active comparator | The group without control of the degrees of freedom (Task Group) will receive a therapeutic intervention equivalent in dose, but without any restriction of joint movement (without the exoskeleton). Each session will be divided into two parts. In the first part, participants will train with combined planes and in a multi-joint manner with the same video games as DoF Group but with the movement sensor in your hand performing 4 direction movements with the upper limb (horizontal, vertical and diagonals).
In the second training part, patients will perform functional tasks: raise and lower your hand on the table, cleaning a table, put cream on the non-paretic arm, hold a bottle, put a piece of bread or something similar in your mouth, wash your face, brush your hair, store items in a basket, brush teeth, wrote and serve water in glass. Receives: Behavioral: Task intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in UE-FMA at the end of the training
Differences between the Upper Extremity Fugl-Meyer Assessment (UE-FMA) at the beginning of the recruitment and at the end of the training
Measured: 3 days post training
Change in UE-FMA at 6 months post stroke
Differences between the Upper Extremity Fugl-Meyer Assessment (UE-FMA) at the beginning of the recruitment and at 6 months post stroke
Measured: 180 days post stroke
Secondary outcomes (6)
Change in ARAT at the end of the training
Differences between the Action Research Arm Test (ARAT) at the beginning of the recruitment and at the end of the training
Measured: 3 days post training
Change in ARAT at 6 months post stroke
Differences between the Action Research Arm Test (ARAT) at the beginning of the recruitment and at 6 months post stroke
Measured: 180 days post stroke
Change in iCoh at the end of the training
Differences between EEG Ipsi-Contralateral Motor Cortex connectivity (iCoh) at the beginning of the training and at the end of the training
Measured: 3 days post training
Change in iCoh connectivity at 6 months post stroke
Differences between EEG Ipsi-Contralateral Motor Cortex connectivity (iCoh) at the beginning of the training and at 6 months post stroke
Measured: 180 days post stroke
Change in arm kinematics at the end of the training
Differences between arm kinematics (shoulder, elbow, wrist and finger angles during reaching and grasping a glass) at the beginning of the training and at the end of the training
Measured: 3 days post training
Change in arm kinematics at 6 months post stroke
Differences between arm kinematics (shoulder, elbow, wrist and finger angles during reaching and grasping a glass) at the beginning of the training and at 6 months post stroke
Measured: 180 days post stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start1 Mar 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Agencia Nacional de Investigación y Desarrollo
- Responsible party
- Principal investigator, Pablo Burgos, University of Chile
- Investigators
- Pablo Burgos, PhD, Study director, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06496529
- Sponsor's protocol ID
- FONDEF IDeA 2023 ID23I104
- Status last verified
- Oct 2026
- First submitted
- 3 Jul 2024
- Last updated
- 6 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected IPD
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ExoDoF: Robotic Exoskeleton for Upper Limb Motor Rehabilitation After Stroke
- ClinicalTrials.gov ID
- NCT06496529
- Acronym / sponsor ID
- FONDEF IDeA 2023 ID23I104
- Conditions
- Stroke
- Keywords
- stroke recovery, motor recovery, upper extremity recovery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Collaborators
- Agencia Nacional de Investigación y Desarrollo
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 11 Jul 2024 (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.
Two decades ago, the projection of recovery of the upper extremity (UE) after a stroke had a very poor prognosis worldwide. Nowadays, thanks to medical advances and early rehabilitation, the prognosis for recovery has improved; however, there is still a limit that no therapy has been able to overcome, related to spontaneous recovery as part of the natural evolution of the pathophysiological process, rather than with the contribution of rehabilitation. Additionally, existing therapies show partial effectiveness on the recovery of UE function, but do not avoid the use of compensatory strategies or alternatives to normal movement. Given this situation, there is an active search for new therapeutic approaches. In this clinical trial the investigators propose a rehabilitation paradigm that promotes the recovery of control of specific planes of movement through the selective restriction of degrees of freedom, simplifying control demands. The investigators sought to test the hypothesis that people with stroke in the early subacute stage and who present alterations in the movement of the upper extremity, a rehabilitation protocol that reduces the degrees of freedom of the UE and trunk, enables greater recovery of the movement of the UE and less use of compensatory movements compared to a protocol without DoF control. The general objective is to demonstrate the effect of training with restriction of the degrees of freedom of UE and trunk, mediated by an exoskeleton and videogames, on the control of the UE.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DoF Group | Experimental | Behavioral: DoF interventionThe experimental group with control of the degrees of freedom will receive treatment for 4 weeks using an exoskeleton and also it will be supervised by a physiotherapist.The exoskeleton will restrict the movement of the trunk and upper extremity to leave only the joint free to work in the plane of interest. The training will be selective in an articular plane with biofeedback of movement through videogames and external movement sensors installed in the upper extremity. This movement sensor will allow to interact with the videogames through the movement of the trained movement. |
| Task Group | Active comparator | Behavioral: Task interventionThe group without control of the degrees of freedom (Task Group) will receive a therapeutic intervention equivalent in dose, but without any restriction of joint movement (without the exoskeleton). Each session will be divided into two parts. In the first part, participants will train with combined planes and in a multi-joint manner with the same video games as DoF Group but with the movement sensor in your hand performing 4 direction movements with the upper limb (horizontal, vertical and diagonals). In the second training part, patients will perform functional tasks: raise and lower your hand on the table, cleaning a table, put cream on the non-paretic arm, hold a bottle, put a piece of bread or something similar in your mouth, wash your face, brush your hair, store items in a basket, brush teeth, wrote and serve water in glass. |
Who may qualify
- Ages
- 18 to 81 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of ischemic or hemorrhagic stroke with zero to twelve weeks of evolution.
- Subjects with alterations in active voluntary movement of ES with Fugl Meyer less than or equal to 50 points. Strength of shoulder abduction and finger extension from palpable contraction (1 in Medical Research Council (MRC) scale for muscle strength).
Key exclusion criteria (6 listed)
- Cognitive impairment that prevents signing the informed consent, following the instructions and understanding the procedures. (MOCA < 18).
- Inability to perform activities sitting for more than 90 minutes or inability to perform activities without severe pain (VAS > 6) or having limited reach ranges.
- Have severe visual impairment that does not allow to carry out the activities associated with the task.
- Previous stroke with neurological sequelae in the upper extremity.
- Present bilateral sensorimotor alterations.
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 |
|---|---|---|
| DoF interventionTraining of specific uniarticular and single plane movement of the upper limb through an exoskeleton and videogames that will be supervised by a physiotherapist. | Behavioural | DoF Group |
| Task interventionTraining of multiarticular upper limb movements (vertical, horizontal and diagonal) through videogames and also training of functional task (raise and lower your hand on the table, cleaning a table, put cream on the non-paretic arm, hold a bottle, put a piece of bread or something similar in your mouth, wash your face, brush your hair, store items in a basket, brush teeth, wrote and serve water in glass). This activities will be supervised by a physiotherapist. | Behavioural | Task Group |
Primary outcome
Change in UE-FMA at the end of the training
Time frame: 3 days post training
Differences between the Upper Extremity Fugl-Meyer Assessment (UE-FMA) at the beginning of the recruitment and at the end of the training
Change in UE-FMA at 6 months post stroke
Time frame: 180 days post stroke
Differences between the Upper Extremity Fugl-Meyer Assessment (UE-FMA) at the beginning of the recruitment and at 6 months post stroke
6 secondary outcomes
Change in ARAT at the end of the training
Time frame: 3 days post training
Change in ARAT at 6 months post stroke
Time frame: 180 days post stroke
Change in iCoh at the end of the training
Time frame: 3 days post training
Change in iCoh connectivity at 6 months post stroke
Time frame: 180 days post stroke
Change in arm kinematics at the end of the training
Time frame: 3 days post training
Change in arm kinematics at 6 months post stroke
Time frame: 180 days post stroke
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: Yes. all collected IPD
Related trials for Stroke
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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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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.
Pablo Burgos, PhD study director
University of Chile
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DoF intervention and Task intervention in people with Stroke, run by University of Chile at 4 sites 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 2 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pablo Burgos, PhD (19713314101, pburgos@uchile.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in UE-FMA at the end of the training (time frame: 3 days post training). The study lists 2 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 6 Oct 2026.