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| ID | Type | Description | Link |
|---|---|---|---|
| FarEasternMH | Registry Identifier | WJKao |
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The aim of this study is to investigate the effect of individualized physical therapy, combined manual therapy and exercise intervention, for pain perception, range of motion (ROM), muscle strength, joint health, cardiopulmonary endurance and quality of life (QoL) in patients with severe hemophilia A and multiple hemophilic arthropathy.
The main clinical manifestations of hemophilia are muscle and joint bleeding. Recurrent bleeding leads to a degenerative process known as hemophilic arthropathy. Past studies investigated the effect of manual therapy of exercise for individuals with hemophilia and found to enhance muscle strength, balance, fitness and promote quality of life. However, less study has evaluated the safety and effectiveness of manual therapy combined with exercise for individuals with multiple hemophilic arthropathy. Therefore, the aim of this study is to investigate the effect of individualized physical therapy, combined manual therapy and exercise intervention, for pain perception, range of motion (ROM), muscle strength, joint health, cardiopulmonary endurance and quality of life (QoL) in patients with severe hemophilia A and multiple hemophilic arthropathy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physiotherapy group | Other | Individualized physiotherapy intervention based on manual therapy and exercise 1 session per week for 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Manual therapy combined exercise | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hemophilia Joint Health Score (HJHS) | To measure joint health, in the domain of body structure and function (i.e. impairment), of the joints most commonly affected by bleeding in hemophilia: the knees, ankles, and elbows. It provides a total score (higher score is worse; max=124), joint specific scores, and a global gait score. | before intervention (baseline), after intervention 6th week and 12th week |
| Visual Analogue Scale (VAS) | To assess the target joint pain in hemophilia. The minimum value is 0, and the maximum value is 10 (higher score is worse). | before intervention (baseline), after intervention 6th week and 12th week |
| 6 minute walk test | To evaluate cardiopulmonary endurance. The predictive equation for males: 6MWD(m) = 867 - (5.71 age, yrs) + (1.03 height, cm). The predictive equation for females: 6MWD(m) = 525 - (2.86 age, yrs) + (2.71 height, cm) - (6.22BMI). | before intervention (baseline), after intervention 6th week and 12th week |
| Hemophilia Activity List (HAL) | To measure the impact of hemophilia on self-perceived functional abilities in adults.Normalized scores for the domains, components, and the full questionnaire can also be obtained. Missing values are controlled for and the possible scores range from 0 to 100, where 0 represents the worst possible functional status and 100 the best possible functional status. | before intervention (baseline), after intervention 6th week and 12th week |
| EQ-5D-5L | To measure the quality of life. Each dimension now has five response levels: no problems (1), slight problems (2), moderate problems (3), severe problems (4), unable to/extreme problems (5). The minimum value is 55555 and the maximum value is 11111 (higher score is worse). EQ VAS：the minimum score is 0, and the maximum score is 100 (higher score is better). |
| Measure | Description | Time Frame |
|---|---|---|
| Daily notes | record each intervention, such as manual therapy and exercise | once a week (each intervention) for 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wan Jung Kao, bachelor | staff | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Far Eastern Memorial hospital | New Taipei City | 220 | Taiwan |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 15, 2026 | |
| Reset | Apr 1, 2026 | |
| Release | Apr 6, 2026 | |
| Unrelease | Apr 7, 2026 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 4, 2024 | Jul 26, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 4, 2024 | Jul 26, 2024 | ICF_001.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 15, 2026 | Apr 1, 2026 | |||
| Apr 6, 2026 | Apr 7, 2026 |
| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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|
| before intervention (baseline), after intervention 6th week and 12th week |
| Jun 25, 2026 |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D001519 | Behavior |