HaemophiliaHeMirrorNCT04549402
Movement Visualization in Pain Management in Patients With Hemophilic Arthropathy.
A study testing Mirror Therapy group and Video group in people with Haemophilia, run by Investigación en Hemofilia y Fisioterapia at 1 site in Spain.
Trial summary
Background. The recurrence of hemarthrosis in patients with hemophilia favors the development of a progressive, degenerative intra-articular lesion (hemophilic arthropathy). Pain is one of the main clinical manifestations of this arthropathy. Objective. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Haemophilia
- What is being tested?
- Mirror Therapy group and Video group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSpain
- Study dates
- 31 Aug 2021to 1 May 2022
- 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 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients diagnosed with hemophilia A and B
- Patients with a medical diagnosis of hemophilic arthropathy and pain
- People over 18 years of age
- Patients on prophylactic or on-demand treatment regimen with FVIII / FIX concentrates
Who cannot join
- Patients with neurological or cognitive disorders that impede understanding of the questionnaires
- Pain free patients
- Amputees, epileptics or patients with severe vision problems
- Patients who are receiving Physiotherapy treatment at the time of the study
- Patients who have not signed the informed consent document
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
European University of Madrid
Madrid, 28670
Rubén Cuesta-Barriuso, PhD, ruben.cuestab@gmail.com
About this study
Official title: Efficacy of a Physiotherapy Intervention Through Movement Visualization in Pain Management in Patients With Hemophilic Arthropathy. Randomized Multicenter Clinical Study.
Background. The recurrence of hemarthrosis in patients with hemophilia favors the development of a progressive, degenerative intra-articular lesion (hemophilic arthropathy). Pain is one of the main clinical manifestations of this arthropathy.
Objective. Assess the safety and efficacy of a pain intervention by visualizing movement using an augmented reality mobile application and immersive 360º video, regarding the frequency of bleeding and the improvement in pain perception and quality of life, joint condition , strength and functionality in patients with hemophilic arthropathy.
Read more
Study design. Randomized, multicenter, single-blind clinical study. Method. 70 patients with hemophilia A and B will be recruited in this study. The patients will be recruited in 5 regions of Spain. The 8 dependent variables will be: frequency of bleeding (self-registration), pain (measured with the visual analog scale and pressure algometer, Tampa Scale of Kinesiophobia and Pain Catastrophizing Scale), quality of life (SF-12 scale), anxiety (questionnaire of Anxiety Status-Trait-STAI), joint status (Hemophilia Joint Health Score scale), muscle strength (dynamometer) and functionality (6-Minutes Walking test, Quick Disabilities of the arm, shoulder and hand). Three evaluations will be carried out: pre-treatment, post-treatment and after a follow-up period of 6 months.
Expected results. To observe the efficacy of the visualization of movement in the characteristics of pain, and its implication in the functionality, joint state, muscular strength and the perception of quality of life in patients with hemophilic arthropathy.
- Conditions
- Haemophilia
- Being tested
- Mirror Therapy group, Video group
- Keywords
- Hemophilic arthropathy, Educative intervention, Pain, Quality of life, Anxiety, Stress
- Medical subject headings
- Hemophilia A, Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirror Therapy groupOther
The intervention protocol will be carried out under the same environmental conditions and, as far as possible, on time. The intervention will last 4 weeks, with a periodicity of 7 weekly sessions. In total there will be 28 sessions lasting between 15 and 45 minutes depending on the number of joints affected.
Video groupOther
The intervention protocol will be carried out under the same environmental conditions and, as far as possible, on time. The intervention will last 4 weeks, with a periodicity of 7 weekly sessions. In total there will be 28 sessions lasting between 15 and 45 minutes depending on the number of joints affected.
| Study group | Role | What they receive |
|---|---|---|
| Mirror Therapy group | Experimental | The intervention will consist of the visualization of movement through the Mirror Therapy VR® application, broadcast on a mobile device and visualized with virtual reality glasses. The knee extension and ankle dorsiflexion movements (quadriceps and sural triceps), together with the elbow flexion (elbow flexors) will be the movements to be performed, based on their functional need (walking and feeding, respectively). Receives: Other: Mirror Therapy group |
| Video group | Active comparator | The intervention will consist of the visualization of movement through the reproduction of an immersive 360º video broadcast on a mobile device and viewed with virtual reality glasses. Knee extension and ankle dorsiflexion movements (quadriceps and sural triceps), together with elbow flexion (elbow flexors) will be the movements to be performed, based on their functional need (ambulation and feeding, respectively). Receives: Other: Video group |
| Control group | No intervention | Patients included in the control group will not receive any physiotherapy intervention. They will continue with their routine prior to the beginning of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline hemarthrosis after treatment and at 2 months
A self-registration will be used to evaluate the frequency of bleeding, and thus the safety of the technique. This self-registration will be given to each patient at the beginning of the study and they must fill in the number of hemarthrosis and their main characteristics: date, origin (traumatic or spontaneous) and location (knee, ankle or elbow). The self-registration will be delivered to the evaluator in each of the study evaluations (post-treatment and follow-up).
Measured: Screening visit, within the first seven days after treatment and after two months follow-up visit
Secondary outcomes (9)
Change from baseline joint pain after treatment and at 2 months
The visual analog scale will be used to assess the perception of joint pain, being valued with a range of 0 to 10 points (from no pain to the maximum pain suffered or imaginable) in the joints evaluated
Measured: Screening visit, within the first seven days after treatment and after two months follow-up visit
Change from baseline pressure pain threshold after treatment and at 2 months
With a pressure algometer (model Wagner FPN100) we will measure the pressure pain threshold, at the joint level and at a distance (in another part of the body). This device measures in Newton / cm2 the pressure at which the subject perceives pain under pressure. A pressure will be made on the chosen point, which we will increase at an approximate speed of 50kPa / s until the patient warns us that the sensation begins to be painful. Hemophilic arthropathy will be assessed in the elbow (on the lateral epicondyle, in the C5-C6 joint and in the tibialis anterior muscle), knee (inner edge of the patella, and tibialis anterior and extensor carpi longus muscles) and ankle (lateral malleolus, L5 spinous process, and extensor carpi longus muscle).
Measured: Screening visit, within the first seven days after treatment and after two months follow-up visit
Change from baseline muscle strength after treatment and at 2 months
With a pressure dynamometer (microFET®2 Digital Handheld model) we will measure the strength of the biceps brachii, quadriceps and triceps surae. This device measures in Newton the force that the patient exerts in the requested muscular action. The higher the value, the greater the muscle strength. We will carry out the measurements bilaterally. The patient will be asked 4 maximum isometric contractions of 5 seconds, with a rest of 30 seconds between them, against the dynamometer located in the hand of the evaluator
Measured: Screening visit, within the first seven days after treatment and after two months follow-up visit
Change from baseline electrical activity of the muscles after treatment and at 2 months
Using surface electromyography (model SHIMMMER2, Shimmer, Ireland), we will evaluate the electrical activity of the musculature and its level of activation. The placement of the electrodes will be marked on the standing subjects, and they will be placed following the European recommendations for the use of the SEMG. A bipolar SEMG system will be used with circular electrodes 10 mm in diameter, 20 mm apart, placed longitudinally, in the direction of the fibers of the studied muscle, and with a remote reference electrode.
Measured: Screening visit, within the first seven days after treatment and after two months follow-up visit
Change from baseline perception of quality of life after treatment and at 2 months
Using the generic Short Form 12 (SF-12v2) scale, the perception of quality of life of the patients included in the study will be evaluated. This scale consists of 12 items and a range from 0 to 100 points (where a higher score indicates a better perception of quality of life).
Measured: Screening visit, within the first seven days after treatment and after two months follow-up visit
Change from baseline perception of anxiety after treatment and at 2 months
With the State-Trait Anxiety Inventory (STAI) scale, the perception of anxiety of the patients included in the study will be measured. The state and the anxiety trait of each subject are evaluated with a score of 0 to 30 points for each scale, where a higher score indicates a higher anxiety index in the trait or state.
Measured: Screening visit, within the first seven days after treatment and after two months follow-up visit
Change from baseline kinesiophobia after treatment and at 2 months
With the Tampa Scale of kinesiophobia (TSK-11SV) questionnaire, the fear of movement of the patients included in the study will be evaluated. It consists of 11 items. Its values have a range of 1 to 4 points, where the higher the score, the greater the fear of movement.
Measured: Screening visit, within the first seven days after treatment and after two months follow-up visit
Change from baseline catastrophizing after treatment and at 2 months
With the Pain catastrophizing scale questionnaire, the catastrophizing of patients with congenital coagulopathies will be measured. The scale, made up of 13 items, is assessed with a range of 0 to 4 points (lower score indicates less catastrophism).
Measured: Screening visit, within the first seven days after treatment and after two months follow-up visit
Change from baseline joint status after treatment and at 2 months
With the Hemophilia Joint Health Score scale, specific for its use in patients with hemophilia, the joint status of patients with hemophilic arthropathy will be evaluated. It evaluates 8 items: inflammation and duration of this, pain, muscle atrophy and strength, crackles, and loss of flexion and extension. It has a score of 0 (no joint damage) to 20 points (maximum joint damage) per joint (elbows, knees and ankles). A gait rating is added to the 120 points (range 0-4 points), the maximum rating on this scale being 124 points.
Measured: Screening visit, within the first seven days after treatment and after two months follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start31 Aug 2021
- Primary completion1 Feb 2022
- Study completion1 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HaemophiliaStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Investigación en Hemofilia y Fisioterapia
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Rubén Cuesta-Barriuso, PhD, Principal investigator, Universidad Europea de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04549402
- Sponsor's protocol ID
- HeMirror
- Acronym
- HeMirror
- Status last verified
- Mar 2022
- First submitted
- 8 Sep 2020
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Physiotherapy Intervention Through Movement Visualization in Pain Management in Patients With Hemophilic Arthropathy. Randomized Multicenter Clinical Study.
- ClinicalTrials.gov ID
- NCT04549402
- Acronym / sponsor ID
- HeMirror / HeMirror
- Conditions
- Haemophilia
- Keywords
- Hemophilic arthropathy, Educative intervention, Pain, Quality of life, Anxiety, Stress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Investigación en Hemofilia y FisioterapiaResearch network
- Study start
- 31 Aug 2021 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 May 2022 (estimated)
- First posted
- 16 Sep 2020 (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.
Background. The recurrence of hemarthrosis in patients with hemophilia favors the development of a progressive, degenerative intra-articular lesion (hemophilic arthropathy). Pain is one of the main clinical manifestations of this arthropathy.
Objective. Assess the safety and efficacy of a pain intervention by visualizing movement using an augmented reality mobile application and immersive 360º video, regarding the frequency of bleeding and the improvement in pain perception and quality of life, joint condition , strength and functionality in patients with hemophilic arthropathy.
Study design. Randomized, multicenter, single-blind clinical study. Method. 70 patients with hemophilia A and B will be recruited in this study. The patients will be recruited in 5 regions of Spain. The 8 dependent variables will be: frequency of bleeding (self-registration), pain (measured with the visual analog scale and pressure algometer, Tampa Scale of Kinesiophobia and Pain Catastrophizing Scale), quality of life (SF-12 scale), anxiety (questionnaire of Anxiety Status-Trait-STAI), joint status (Hemophilia Joint Health Score scale), muscle strength (dynamometer) and functionality (6-Minutes Walking test, Quick Disabilities of the arm, shoulder and hand). Three evaluations will be carried out: pre-treatment, post-treatment and after a follow-up period of 6 months.
Expected results. To observe the efficacy of the visualization of movement in the characteristics of pain, and its implication in the functionality, joint state, muscular strength and the perception of quality of life in patients with hemophilic arthropathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mirror Therapy group | Experimental | Other: Mirror Therapy groupThe intervention will consist of the visualization of movement through the Mirror Therapy VR® application, broadcast on a mobile device and visualized with virtual reality glasses. The knee extension and ankle dorsiflexion movements (quadriceps and sural triceps), together with the elbow flexion (elbow flexors) will be the movements to be performed, based on their functional need (walking and feeding, respectively). |
| Video group | Active comparator | Other: Video groupThe intervention will consist of the visualization of movement through the reproduction of an immersive 360º video broadcast on a mobile device and viewed with virtual reality glasses. Knee extension and ankle dorsiflexion movements (quadriceps and sural triceps), together with elbow flexion (elbow flexors) will be the movements to be performed, based on their functional need (ambulation and feeding, respectively). |
| Control group | No intervention | –Patients included in the control group will not receive any physiotherapy intervention. They will continue with their routine prior to the beginning of the study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients diagnosed with hemophilia A and B
- Patients with a medical diagnosis of hemophilic arthropathy and pain
- People over 18 years of age
- Patients on prophylactic or on-demand treatment regimen with FVIII / FIX concentrates
Key exclusion criteria (5 listed)
- Patients with neurological or cognitive disorders that impede understanding of the questionnaires
- Pain free patients
- Amputees, epileptics or patients with severe vision problems
- Patients who are receiving Physiotherapy treatment at the time of the study
- Patients who have not signed the informed consent document
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 Therapy groupThe intervention protocol will be carried out under the same environmental conditions and, as far as possible, on time. The intervention will last 4 weeks, with a periodicity of 7 weekly sessions. In total there will be 28 sessions lasting between 15 and 45 minutes depending on the number of joints affected. | Other | Mirror Therapy group |
| Video groupThe intervention protocol will be carried out under the same environmental conditions and, as far as possible, on time. The intervention will last 4 weeks, with a periodicity of 7 weekly sessions. In total there will be 28 sessions lasting between 15 and 45 minutes depending on the number of joints affected. | Other | Video group |
Primary outcome
Change from baseline hemarthrosis after treatment and at 2 months
Time frame: Screening visit, within the first seven days after treatment and after two months follow-up visit
A self-registration will be used to evaluate the frequency of bleeding, and thus the safety of the technique. This self-registration will be given to each patient at the beginning of the study and they must fill in the number of hemarthrosis and their main characteristics: date, origin (traumatic or spontaneous) and location (knee, ankle or elbow). The self-registration will be delivered to the evaluator in each of the study evaluations (post-treatment and follow-up).
9 secondary outcomes
Change from baseline joint pain after treatment and at 2 months
Time frame: Screening visit, within the first seven days after treatment and after two months follow-up visit
Change from baseline pressure pain threshold after treatment and at 2 months
Time frame: Screening visit, within the first seven days after treatment and after two months follow-up visit
Change from baseline muscle strength after treatment and at 2 months
Time frame: Screening visit, within the first seven days after treatment and after two months follow-up visit
Change from baseline electrical activity of the muscles after treatment and at 2 months
Time frame: Screening visit, within the first seven days after treatment and after two months follow-up visit
Change from baseline perception of quality of life after treatment and at 2 months
Time frame: Screening visit, within the first seven days after treatment and after two months follow-up visit
Change from baseline perception of anxiety after treatment and at 2 months
Time frame: Screening visit, within the first seven days after treatment and after two months follow-up visit
Change from baseline kinesiophobia after treatment and at 2 months
Time frame: Screening visit, within the first seven days after treatment and after two months follow-up visit
Change from baseline catastrophizing after treatment and at 2 months
Time frame: Screening visit, within the first seven days after treatment and after two months follow-up visit
Change from baseline joint status after treatment and at 2 months
Time frame: Screening visit, within the first seven days after treatment and after two months follow-up visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Individual participant dataSharing planned: No
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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.
Rubén Cuesta-Barriuso, PhD principal investigator
Universidad Europea de Madrid
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 group and Video group in people with Haemophilia, run by Investigación en Hemofilia y Fisioterapia 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 4 inclusion and 5 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 31 Mar 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 Rubén Cuesta-Barriuso, PhD (+34 913146508, ruben.cuestab@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline hemarthrosis after treatment and at 2 months (time frame: Screening visit, within the first seven days after treatment and after two months follow-up visit). 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 31 Mar 2022.