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NCT Number: NCT04309903

The Effects of Manual Therapy in Hemophilic Patients

Uncertainty about how to treat existing hemophilic arthropathy (HA) is the most important issue that will increase functionality and joint health. Recent studies have shown that MT can be used safely for improving joint health, pain and ROM with no bleedings in PwH with elbow and ankle HA. Unlike MT studies in hemophilia, we investigated the effects of MT on important parameters such as muscle strength (MS), functional level, joint health, functional independence score in hemophilia (FISH) and kinesiophobia. These parameters are closely related to functional level and quality of life of PwH. Therefore, evaluation of these parameters and determining the effects of the MT on these parameters are very important for both PwH and also clinicians.

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Key information

Conditions

Hemophilia Arthropathy Hemophilic Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemophilia A Hemorrhagic Disorders Joint Diseases Musculoskeletal Diseases

Age range

18 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Cukurova University

Adana, Sarıcam, 01330, Turkey (Türkiye)

About this study

The aim of this study was to investigate the effects of manual therapy in addition to home exercise program on hemophilia functional independence level, joint health, kinesiophobia, functional level, range of motion, muscle strength and pain level in hemophilic individuals with lower extremity joint arthropathy. Hemophilic arthropathy was developed in at least one of the lower extremity joints and aged between 18-30 years 17 severe type hemophilic men were participated in the study. The participants were divided into two groups as Home Exercise Group (HEG) and Manual Therapy Group (MTG) by randomization method. While the HEG was performed the exercise program at home, in addition to the same HEG manual therapy were applied to the MTG by the same physiotherapist 3 days a week for 1 hour. Both groups were followed for a total of 5 weeks and pre-treatment evaluations were repeated post-treatment. The joint health of the hemophilics in both groups were evaluated with Hemophilia Joint Health Score (HJHS), their kinesiophobia level were evaluated with Tampa Kinesophobia Scale, their functionality with the Functional Independence Score in Hemophilia (FISH). In addition, Functional Reach, Timed Up and Go and 5 Times Sit-to- Stand tests were used for functional level. The range of motion was evaluated with a goniometer, muscle strength was measured with a digital dynamometer and pain level was assessed with a Visual Analogue Scale (VAS). Number of hemarthrosis decreased in both groups.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with hemophilia who have arthropathy developed in any of the lower extremity joints due to severe hemophilia and to be receiving regular prophylaxis (3*1500 IU/ per week), but not having regular physical activity and sports.

Exclusion criteria

  • Patients with hemophilia who had any disease related to connective tissue, any surgery that affects lower limb function (joint debridement, fracture, prosthesis), any neurological disease or cognitive impairment that may affect functional level, any sensorial loss of peripheral nerve injury and did not attend their sessions and evaluations regularly.

Treatment and study plan

Manual therapy

Other

Both groups received for 3 sessions per week, a total of 5 weeks. Home exercises were performed by the patient for 30 minutes at home.In home exercises active ROM for warm-up (5 min), passive stretchening (5 min), strengthening exercises (10 min), proprioceptive and balance exercises (10 min). In manual therapy group, myofascial release techniques (MRT) and Kalternborn mobilization techniques lasted about one hour. In MRT, each manuever was applied for 2 mins and 3 times. The superficial strokes were performed, assisted by slight movements of joints. MRT to posterior capsule of the knee, ligaments, iliotibial tractus, plantar fascia, metatarsal, tarsals, and toes. Kalterborb mobilization tecnqiues; posterior gliding for restricted knee flexion, anterior gliding for restricted knee extension,talocrural posteior gliding for dorsal flexion, talocrural anterior gliding for plantar flexion.3 * 10 repetitions, 20 sec of per reps and 10 sec of interval.

Other names: Home exercise

Primary outcomes

  1. Hemophilia Joint Health Score

    Time frame: 5 week

    We used the index point of joints. Score ranged from 0 to 20. Low score indicates the good joint health

  2. Functional Independence Score in Hemophilia

    Time frame: 5 week

    We used the functional independence of patients. Score ranged from 0 to 32. High score indicates the functional independence.

  3. Tampa Kinesiophobia Scale

    Time frame: 5 week

    Score higher than 37 were associated with a high degree of kinesiophobia.

Secondary outcomes

  1. Range of motion

    Time frame: 5 week

    Joint range was measured with a universal goniometer.

  2. Muscle Strength

    Time frame: 5 week

    It was measured with hand-held dynamometer.

  3. Numerical Pain Scale

    Time frame: 5 week

    It was used for assessment of activity and resting pain.

  4. Frequency bleeding

    Time frame: 5 week

    It was evaluated from the diaries kept by the patients

  5. Functional Reach

    Time frame: 5 week

    It was used to assess dynamic balance.

  6. Timed Up and Go

    Time frame: 5 week

    It was used to evaluate functional mobility, dynamic balance, fall risk and postural stability.

  7. 5 Times Sit to Stand

    Time frame: 5 week

    It was evaluated the functional strength of lower extremity, transitive movements, balance and fall risk.

Sponsors and collaborators

Lead sponsor

Necmettin Erbakan University

Other

Registry information

Official study title

The Effectiveness of Manual Theraphy on Lower Extremity Joint Arthropathy in Patients With Hemophilia

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 16, 2020
Registry last updated
Mar 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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