HemophiliaNCT04237766
Movement Visualization in Patients With Hemophilic Arthropathy
A study testing Experimental group in people with Hemophilia, run by Real Fundación Victoria Eugenia.
Trial summary
Background. The recurrence of hemarthrosis in patients with hemophilia favors the development of an intra-articular, degenerative and progressive 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
- Hemophilia
- What is being tested?
- Experimental group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2020to 1 May 2021
- 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
- Medical diagnosis of hemophilic arthropathy
- Chronic joint pain
- Over 18 years
- On prophylactic treatment or on demand with FVIII / FIX concentrates
Who cannot join
- Patients with neurological or cognitive disorders that impede the understanding of the questionnaires
- Painless patients
- Amputee, epileptic or seriously impaired vision patients
- Patients receiving physiotherapy treatment at the time of the study
- Patients who have not signed the informed consent document.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Safety and Effectiveness of a Physiotherapy Intervention Through Movement Visualization in the Approach of Pain in Patients With Hemophilic Arthropathy. Multicenter Randomized Clinical Study.
Background. The recurrence of hemarthrosis in patients with hemophilia favors the development of an intra-articular, degenerative and progressive lesion (hemophilic arthropathy). Pain is one of the main clinical manifestations of this arthropathy.
Objective. Assess the safety and efficacy of an intervention in pain through visualization of the movement using a mobile application of augmented reality and immersive 360º video, regarding the frequency of bleeding and the improvement of pain perception and quality of life, joint state , strength and functionality in patients with hemophilic arthropathy.
Read more
Study design. Randomized, multicenter, simple blind clinical study.
Method. 140 patients with hemophilia A and B will be recruited in this study. 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 analogue scale and pressure algometer, Tampa Scale of Kinesiophobia and Pain Catastrophizing Scale), quality of life (SF-12 scale), anxiety (questionnaire Anxiety State-Trait-STAI), joint state (Hemophilia Joint Health Score scale), muscular 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 6-month follow-up period.
Expected results. Observe the effectiveness of movement visualization in the characteristics of pain, and its implication in functionality, joint state, muscular strength and the perception of quality of life in patients with hemophilic arthropathy.
- Conditions
- Hemophilia
- Being tested
- Experimental 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.
Experimental groupOther
The intervention will consist of the visualization of the movement through the Mirror Therapy application, or through the reproduction of an immersive 360º video emitted on a mobile device and visualized with virtual reality glasses.
The movements observed with both technologies will be the same. The knee extension and dorsal ankle flexion movements (quadriceps and triceps sural), together with the elbow flexion (elbow flexors) will be the movements to be performed, based on their functional need (ambulation and feeding, respectively).
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | All patients included in the experimental group should be on prophylactic treatment with factor 8 (FVIII) or factor 9 (FIX) concentrates. Likewise, the factor should be administered on the same day that they receive each movement display therapy treatment sessions. Each session will last approximately 40 minutes, with 7 physiotherapy sessions a week taking place over a period of 4 weeks. Receives: Other: Experimental group |
| Control group | No intervention | Subjects included in the control group will not receive physical therapy through mirror therapy and motion display. They will continue with their usual routine of physical activity and exercise, and with the same pharmacological treatment regimen with factor 8 (FVIII) or factor 9 (FIX) concentrates. At the end of the study period the intervention will be applied under the same conditions as the experimental group, analyzing the overall sample at the end of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline joint bleeding frequency after treatment and at 6 months
A self-registration of hemorrhages will be used to assess the frequency of bleeding, and with it the safety of the technique. In the self-registration of bleeding, which will be delivered to each patient at the beginning of the study, the patient must fill in the number of hemarthrosis and the main characteristics of these: date, origin (traumatic or spontaneous) and location (knee, ankle or elbow). The self-registration will be delivered to the evaluator in each of the evaluations of the study (post-treatment and follow-up).
Measured: Screening visit, within the first seven days after treatment and after six months follow-up visit
Secondary outcomes (11)
Change from baseline joint pain after treatment and at 6 months
The visual analogue scale will be used to assess the perception of joint pain, assessing with a range of 0 to 10 points (from no pain to the maximum pain suffered or imaginable) ankle joint pain.
Measured: Screening visit, within the first seven days after treatment and after six months follow-up visit
Change from baseline joint pain perception after treatment and at 6 months
With a pressure algometer (model Wagner, Wagner Instruments, CT, USA). We will measure pain at pressure, both at the articular level and at a distance (in another part of the body) of patients with hemophilic arthropathy. This device measures in Newton / cm2 the pressure at which the subject perceives pain at the pressure. A pressure will be made on the chosen point, which will increase at an approximate speed of 50 kilopascal / s until the patient warns us that the sensation begins to be painful.
Measured: Screening visit, within the first seven days after treatment and after six months follow-up visit
Change from baseline muscle strength after treatment and at 6 months
With a pressure hand dynamometer the strength of the brachial biceps, quadriceps and sural triceps muscles will be measured. This device measures in Newton the force that the patient performs in the requested muscular action. The higher the value, the greater the muscular strength. We will perform the measurements bilaterally. In measuring the strength of all the muscles evaluated, the average value of the 4 measurements obtained will be used as a measure.
Measured: Screening visit, within the first seven days after treatment and after six months follow-up visit
Change from baseline electrical muscle activity after treatment and at 6 months
Using surface electromyography we will evaluate the electrical activity of the musculature and its activation level. The placement of the electrodes will be marked on the standing subjects, and will be placed following the European recommendations for the use of the surface electromyography. A bipolar surface electromyography system with circular electrodes of 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 will be used. A baseline measurement will be performed before the intervention and another during the movement visualization in order to measure the change. The unit of measure is microvolts (µV). The higher the score, the greater the muscular activation.
Measured: Screening visit, within the first seven days after treatment and after six months follow-up visit
Change from baseline perception of quality of life after treatment and at 6 months
The perception of quality of life of the patients included in the study will be measured with the Short Form 12 questionnaire (SF-12v2). It consists of 12 items and a range of 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 six months follow-up visit
Change from baseline anxiety perception after treatment and at 6 months
The anxiety perception of the patients included in the study will be measured with the State-Trait Anxiety Inventory (STAI) questionnaire. The state and anxiety trait of each subject is evaluated with a score of 0 to 30 points for each scale, where a higher score indicates a higher index of anxiety in the trait or state.
Measured: Screening visit, within the first seven days after treatment and after six months follow-up visit
Change from baseline fear of movement after treatment and at 6 months
We will measure the fear of movement of the patients included in the study with the Tampa Scale of kinesiophobia (TSK-11SV) questionnaire. It consists of 11 items. Their 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 six months follow-up visit
Change from baseline catastrophism after treatment and at 6 months
We will measure the catastrophism of the patients included in the study with the Pain catastrophizing scale questionnaire. The scale, composed of 13 items, is valued with a range of 0 to 4 points (lower score indicates lower catastrophism).
Measured: Screening visit, within the first seven days after treatment and after six months follow-up visit
Change from baseline anxiety perceived after treatment and at 6 months
The anxiety perceived by the patients included in the study at the time of the intervention will be measured with the Subjective Units of Discomfort Scales questionnaire. This scale, graduated from 0 to 100 where 100 indicates the worst anxiety or discomfort lived or imaginable by the subject, consists of anchored scale a 100mm line will be used where the corresponding value will be marked.
Measured: Screening visit, within the first seven days after treatment and after six months follow-up visit
Change from baseline endogenous pain inhibitory system after treatment and at 6 months
The evaluation of the endogenous pain inhibitory system, by facilitating or inhibiting the responses to a conditioned stimulus, will be measured with the Conditioned Pain Modulation Index (CPMI). To perform the evaluation of the diffuse descending inhibitor system, tonic pain will occur by pressing on a non-painful area. First, we will measure the threshold of pain at pressure at the base of the dorsal part of the distal phalanx of the thumb, and then we will cause the conditioned stimulus using the ischemia test on the contralateral upper limb. In this case, for the ischemia test, a sphygmomanometer will be used that will be placed in the arm about 14 cm from the ulnar fossa. The sphygmomanometer will inflate to 240 mmHg and the arm will be placed horizontally.
Measured: Screening visit, within the first seven days after treatment and after six months follow-up visit
Change from baseline joint status after treatment and at 6 months
The joint status of patients with hemophilic arthropathy will be measured with the Hemophilia Joint Health Score. This specific scale for use in patients with hemophilia evaluates 8 items: inflammation and duration, pain, atrophy and muscle strength, crepitations, 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). To the 120 points a gait rating is added (range 0-4 points), the maximum rating of this scale being 124 points.
Measured: Screening visit, within the first seven days after treatment and after six 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 posted23 Jan 2020
- Study start1 May 2020 (estimated)
- Primary completion1 Oct 2020 (estimated)
- Study completion1 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemophiliaStudies 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
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Real Fundación Victoria Eugenia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04237766
- Sponsor's protocol ID
- He-Mirror
- Status last verified
- Jan 2020
- First submitted
- 19 Jan 2020
- Last updated
- 27 Jan 2020
- 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 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of a Physiotherapy Intervention Through Movement Visualization in the Approach of Pain in Patients With Hemophilic Arthropathy. Multicenter Randomized Clinical Study.
- ClinicalTrials.gov ID
- NCT04237766
- Acronym / sponsor ID
- He-Mirror
- Conditions
- Hemophilia
- Keywords
- Hemophilic arthropathy, Educative intervention, Pain, Quality of life, Anxiety, Stress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Real Fundación Victoria EugeniaUniversity, hospital or other
- Study start
- 1 May 2020 (estimated)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 1 May 2021 (estimated)
- First posted
- 23 Jan 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 an intra-articular, degenerative and progressive lesion (hemophilic arthropathy). Pain is one of the main clinical manifestations of this arthropathy.
Objective. Assess the safety and efficacy of an intervention in pain through visualization of the movement using a mobile application of augmented reality and immersive 360º video, regarding the frequency of bleeding and the improvement of pain perception and quality of life, joint state , strength and functionality in patients with hemophilic arthropathy.
Study design. Randomized, multicenter, simple blind clinical study.
Method. 140 patients with hemophilia A and B will be recruited in this study. 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 analogue scale and pressure algometer, Tampa Scale of Kinesiophobia and Pain Catastrophizing Scale), quality of life (SF-12 scale), anxiety (questionnaire Anxiety State-Trait-STAI), joint state (Hemophilia Joint Health Score scale), muscular 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 6-month follow-up period.
Expected results. Observe the effectiveness of movement visualization in the characteristics of pain, and its implication in 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
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Experimental groupAll patients included in the experimental group should be on prophylactic treatment with factor 8 (FVIII) or factor 9 (FIX) concentrates. Likewise, the factor should be administered on the same day that they receive each movement display therapy treatment sessions. Each session will last approximately 40 minutes, with 7 physiotherapy sessions a week taking place over a period of 4 weeks. |
| Control group | No intervention | –Subjects included in the control group will not receive physical therapy through mirror therapy and motion display. They will continue with their usual routine of physical activity and exercise, and with the same pharmacological treatment regimen with factor 8 (FVIII) or factor 9 (FIX) concentrates. At the end of the study period the intervention will be applied under the same conditions as the experimental group, analyzing the overall sample at the end 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 (5 listed)
- Patients diagnosed with hemophilia A and B
- Medical diagnosis of hemophilic arthropathy
- Chronic joint pain
- Over 18 years
- On prophylactic treatment or on demand with FVIII / FIX concentrates
Key exclusion criteria (5 listed)
- Patients with neurological or cognitive disorders that impede the understanding of the questionnaires
- Painless patients
- Amputee, epileptic or seriously impaired vision patients
- Patients 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 |
|---|---|---|
| Experimental groupThe intervention will consist of the visualization of the movement through the Mirror Therapy application, or through the reproduction of an immersive 360º video emitted on a mobile device and visualized with virtual reality glasses. The movements observed with both technologies will be the same. The knee extension and dorsal ankle flexion movements (quadriceps and triceps sural), together with the elbow flexion (elbow flexors) will be the movements to be performed, based on their functional need (ambulation and feeding, respectively). | Other | Experimental group |
Primary outcome
Change from baseline joint bleeding frequency after treatment and at 6 months
Time frame: Screening visit, within the first seven days after treatment and after six months follow-up visit
A self-registration of hemorrhages will be used to assess the frequency of bleeding, and with it the safety of the technique. In the self-registration of bleeding, which will be delivered to each patient at the beginning of the study, the patient must fill in the number of hemarthrosis and the main characteristics of these: date, origin (traumatic or spontaneous) and location (knee, ankle or elbow). The self-registration will be delivered to the evaluator in each of the evaluations of the study (post-treatment and follow-up).
11 secondary outcomes
Change from baseline joint pain after treatment and at 6 months
Time frame: Screening visit, within the first seven days after treatment and after six months follow-up visit
Change from baseline joint pain perception after treatment and at 6 months
Time frame: Screening visit, within the first seven days after treatment and after six months follow-up visit
Change from baseline muscle strength after treatment and at 6 months
Time frame: Screening visit, within the first seven days after treatment and after six months follow-up visit
Change from baseline electrical muscle activity after treatment and at 6 months
Time frame: Screening visit, within the first seven days after treatment and after six months follow-up visit
Change from baseline perception of quality of life after treatment and at 6 months
Time frame: Screening visit, within the first seven days after treatment and after six months follow-up visit
Change from baseline anxiety perception after treatment and at 6 months
Time frame: Screening visit, within the first seven days after treatment and after six months follow-up visit
Change from baseline fear of movement after treatment and at 6 months
Time frame: Screening visit, within the first seven days after treatment and after six months follow-up visit
Change from baseline catastrophism after treatment and at 6 months
Time frame: Screening visit, within the first seven days after treatment and after six months follow-up visit
Change from baseline anxiety perceived after treatment and at 6 months
Time frame: Screening visit, within the first seven days after treatment and after six months follow-up visit
Change from baseline endogenous pain inhibitory system after treatment and at 6 months
Time frame: Screening visit, within the first seven days after treatment and after six months follow-up visit
Change from baseline joint status after treatment and at 6 months
Time frame: Screening visit, within the first seven days after treatment and after six 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 27 Jan 2020.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental group in people with Hemophilia, run by Real Fundación Victoria Eugenia.
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 5 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 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Cuesta-Barriuso (+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 joint bleeding frequency after treatment and at 6 months (time frame: Screening visit, within the first seven days after treatment and after six 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 27 Jan 2020.