StrokeNCT04163666
Effects of Mirror Therapy and Cognitive Therapeutic Exercise in Stroke Patients
A study testing Mirror therapy and Cognitive therapeutic exercise in people with Stroke and Hemiparesis, run by Universidad de Burgos at 1 site in Spain.
Trial summary
This is a randomized clinical trial aimed at patients with a diagnosis of residual hemiparesis due to ischemic or hemorrhagic stroke. Its objective is to evaluate the effects of the mirror therapy and cognitive therapeutic exercise, both in combination with task-oriented motor learning, to achieve maximum… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke, Hemiparesis
- What is being tested?
- Mirror therapy and Cognitive therapeutic exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2020to 31 Oct 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of residual hemiparesis due to ischemic or hemorrhagic stroke,
- Movements of the affected upper members classified between stages II and IV on the Brunnstrom Scale
- Score on the Montreal Cognitive Assessment (MOCA) scale equal to or over 26
Who cannot join
- Heminegligence
- Wernicke's aphasia
- Visual deficits (homonymous hemianopsia)
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Universitary Hospital of Burgos
Burgos, 09006
Raul Soto-Cámara, PhD, +34 673192039, rscamara@ubu.es
Jeronimo Gonzalez-Bernal, PhD, +34 947499108, jejavier@ubu.es
About this study
Official title: Effects of Mirror Therapy and Cognitive Therapeutic Exercise on Improvements to the Upper Member Functions of Stroke Patients: a Randomized Clinical Test Study Protocol
This is a randomized clinical trial aimed at patients with a diagnosis of residual hemiparesis due to ischemic or hemorrhagic stroke. Its objective is to evaluate the effects of the mirror therapy and cognitive therapeutic exercise, both in combination with task-oriented motor learning, to achieve maximum functionality of the affected upper member,
Read the detailed description
Objective: To assess the effect at 3 months of the of the mirror therapy and cognitive therapeutic exercise, both in combination with task-oriented motor learning, applied for 30 days in the functionality of the affected upper member, cognitive performance, emotional state, performance of daily living activities and quality of life in stroke patients.
Design and setting: A randomized clinical trial of three parallel groups.
Population: 152 patients with residual hemiparesis due to ischemic or hemorrhagic stroke will be included, selected by consecutive sampling at the Neurological Service and Stroke Unit of the University Hospital of Burgos (HUBU).
Measurements and intervention: Functionality of the affected upper member, cognitive performance, emotional state, performance of daily living activities and health-related quality of life will be evaluated. The intervention groups will receive a treatment based either on mirror therapy or on congnitive therapeutic exercise, both combined with task-oriented motor learning for 30 days. No additional intervention with the participants of the control group will be completed.
- Conditions
- Stroke, Hemiparesis
- Being tested
- Mirror therapy, Cognitive therapeutic exercise
- Keywords
- Stroke, Upper member, Neurorehabilitation, Mirror therapy, Therapeutic cognitive exercise, Perfetti
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirror therapyBehavioural
The intervention will take place at the home of the participant for 6 weeks (30 days), during 60-minute sessions, 30 of which will be for mirror therapy, while the remaining 30 minutes will be for task-oriented motor learning
Cognitive therapeutic exerciseBehavioural
The intervention will take place at the home of the participant for 6 weeks (30 days), during 60-minute sessions, 30 of which will be for cognoscitive therapeutic exercise, while the remaining 30 minutes will be for task-oriented motor learning
| Study group | Role | What they receive |
|---|---|---|
| Mirror therapy group | Experimental | The mirror therapy group will receive a treatment based on this therapy, combined with task-oriented motor learning. Receives: Behavioral: Mirror therapy |
| Cognitive therapeutic exercise group | Experimental | The cognitive therapeutic exercise group will receive a treatment based on this therapy, combined with task-oriented motor learning. Receives: Behavioral: Cognitive therapeutic exercise |
| Control Group | No intervention | No additional intervention with the participants of this group will be completed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functionality of the affected upper member.
Measurement by Fugl-Meyer Scale: Score between 0 (worst functionality) and 126 (best functionality)
Measured: 3 months
Secondary outcomes (5)
Spasticity of the upper member
Measurement by Ashworth Scale: Score between 0 (best situation) and 5 (worst situation)
Measured: 3 months
Cognitive performance.
Measurement by Montreal Cognitive Assessment Scale: Score between 0 (worst cognitive situation ) and 30 (best cognitive situation)
Measured: 3 months
Emotional state and quality of life.
Measurement by Post-Stroke Quality of Life Scale: Score between 30 (best state) and 155 (worst state)
Measured: 3 months
Basic Daily Living Activities
Measurement by Functional Independence Measure - Functional Assessment Measure: Score between 30 (worst situation) and 210 (best situation)
Measured: 3 months
Instrumental activities of daily living
Measurement by Lawton-Brody Index: Score between 0 (worst state) and 6 (best state)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2019
- Study start1 Jan 2020
- Primary completion30 Oct 2022 (estimated)
- Study completion31 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Burgos
- Sponsor type
- University, hospital or other
- Collaborators
- Castilla-León Health Service
- Responsible party
- Sponsor
- Investigators
- Raul Soto-Camara, PhD, Principal investigator, Burgos UniversityJeronimo Gonzalez-Bernal, PhD, Principal investigator, Burgos University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04163666
- Sponsor's protocol ID
- UBU-HUBU: MT-CTE
- Status last verified
- Jun 2022
- First submitted
- 6 Nov 2019
- Last updated
- 27 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gonzalez-Santos J, Soto-Camara R, Rodriguez-Fernandez P, Jimenez-Barrios M, Gonzalez-Bernal J, Collazo-Riobo C, Jahouh M, Bravo-Anguiano Y, Trejo-Gabriel-Galan JM. Effects of home-based mirror therapy and cognitive therapeutic exercise on the improvement of the upper extremity functions in patients with severe hemiparesis after a stroke: a protocol for a pilot randomised clinical trial. BMJ Open. 2020 Sep 25;10(9):e035768. doi: 10.1136/bmjopen-2019-035768.
PubMed 32978182
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mirror Therapy and Cognitive Therapeutic Exercise on Improvements to the Upper Member Functions of Stroke Patients: a Randomized Clinical Test Study Protocol
- ClinicalTrials.gov ID
- NCT04163666
- Acronym / sponsor ID
- UBU-HUBU: MT-CTE
- Conditions
- Stroke, Hemiparesis
- Keywords
- Stroke, Upper member, Neurorehabilitation, Mirror therapy, Therapeutic cognitive exercise, Perfetti
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Universidad de BurgosUniversity, hospital or other
- Collaborators
- Castilla-León Health Service
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Oct 2022 (estimated)
- Study completion
- 31 Oct 2023 (estimated)
- First posted
- 15 Nov 2019 (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.
This is a randomized clinical trial aimed at patients with a diagnosis of residual hemiparesis due to ischemic or hemorrhagic stroke. Its objective is to evaluate the effects of the mirror therapy and cognitive therapeutic exercise, both in combination with task-oriented motor learning, to achieve maximum functionality of the affected upper member,
Detailed description
Objective: To assess the effect at 3 months of the of the mirror therapy and cognitive therapeutic exercise, both in combination with task-oriented motor learning, applied for 30 days in the functionality of the affected upper member, cognitive performance, emotional state, performance of daily living activities and quality of life in stroke patients.
Design and setting: A randomized clinical trial of three parallel groups.
Population: 152 patients with residual hemiparesis due to ischemic or hemorrhagic stroke will be included, selected by consecutive sampling at the Neurological Service and Stroke Unit of the University Hospital of Burgos (HUBU).
Measurements and intervention: Functionality of the affected upper member, cognitive performance, emotional state, performance of daily living activities and health-related quality of life will be evaluated. The intervention groups will receive a treatment based either on mirror therapy or on congnitive therapeutic exercise, both combined with task-oriented motor learning for 30 days. No additional intervention with the participants of the control group will be completed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mirror therapy group | Experimental | Behavioral: Mirror therapyThe mirror therapy group will receive a treatment based on this therapy, combined with task-oriented motor learning. |
| Cognitive therapeutic exercise group | Experimental | Behavioral: Cognitive therapeutic exerciseThe cognitive therapeutic exercise group will receive a treatment based on this therapy, combined with task-oriented motor learning. |
| Control Group | No intervention | –No additional intervention with the participants of this group will be completed. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of residual hemiparesis due to ischemic or hemorrhagic stroke,
- Movements of the affected upper members classified between stages II and IV on the Brunnstrom Scale
- Score on the Montreal Cognitive Assessment (MOCA) scale equal to or over 26
Key exclusion criteria (3 listed)
- Heminegligence
- Wernicke's aphasia
- Visual deficits (homonymous hemianopsia)
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 |
|---|---|---|
| Mirror therapyThe intervention will take place at the home of the participant for 6 weeks (30 days), during 60-minute sessions, 30 of which will be for mirror therapy, while the remaining 30 minutes will be for task-oriented motor learning | Behavioural | Mirror therapy group |
| Cognitive therapeutic exerciseThe intervention will take place at the home of the participant for 6 weeks (30 days), during 60-minute sessions, 30 of which will be for cognoscitive therapeutic exercise, while the remaining 30 minutes will be for task-oriented motor learning | Behavioural | Cognitive therapeutic exercise group |
Primary outcome
Functionality of the affected upper member.
Time frame: 3 months
Measurement by Fugl-Meyer Scale: Score between 0 (worst functionality) and 126 (best functionality)
5 secondary outcomes
Spasticity of the upper member
Time frame: 3 months
Cognitive performance.
Time frame: 3 months
Emotional state and quality of life.
Time frame: 3 months
Basic Daily Living Activities
Time frame: 3 months
Instrumental activities of daily living
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2022.
- Derived from this study: PubMed 32978182Gonzalez-Santos J, Soto-Camara R, Rodriguez-Fernandez P, Jimenez-Barrios M, Gonzalez-Bernal J, Collazo-Riobo C, Jahouh M, Bravo-Anguiano Y, Trejo-Gabriel-Galan JM. Effects of home-based mirror therapy and cognitive therapeutic exercise on the improvement of the upper extremity functions in patients with severe hemiparesis after a stroke: a protocol for a pilot randomised clinical trial. BMJ Open. 2020 Sep 25;10(9):e035768. doi: 10.1136/bmjopen-2019-035768.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Raul Soto-Camara, PhD principal investigator
Burgos University
Jeronimo Gonzalez-Bernal, PhD principal investigator
Burgos University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mirror therapy and Cognitive therapeutic exercise in people with Stroke and Hemiparesis, run by Universidad de Burgos at 1 site in Spain.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 27 Jun 2022. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raul Soto-Camara, PhD (+34 673192039, rscamara@ubu.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functionality of the affected upper member. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04163666, which also lists 1 linked publication.
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 27 Jun 2022.