Clinical trial NCT04309903: The Effects of Manual Therapy in Hemophilic Patients
Official title: The Effectiveness of Manual Theraphy on Lower Extremity Joint Arthropathy in Patients With Hemophilia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemophilia
Arthropathy Hemophilic
Keywords: Hemophilia
Arthropathy
Physiotherapy
Manual therapy
Joint health
Lead sponsor: Necmettin Erbakan University
Sponsor class: OTHER
First posted: 2020-03-16
Enrollment: 17
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Hemophilia Joint Health Score
timeFrame: 5 week
measure: Functional Independence Score in Hemophilia
timeFrame: 5 week
measure: Tampa Kinesiophobia Scale
timeFrame: 5 week
Secondary outcomes:
measure: Range of motion
timeFrame: 5 week
measure: Muscle Strength
timeFrame: 5 week
measure: Numerical Pain Scale
timeFrame: 5 week
measure: Frequency bleeding
timeFrame: 5 week
measure: Functional Reach
timeFrame: 5 week
measure: Timed Up and Go
timeFrame: 5 week
measure: 5 Times Sit to Stand
timeFrame: 5 week
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Cukurova University
state: Sarıcam
Study officials:
affiliation: Hacettepe University, Faculty of Physiotherapy and Rehabilitation
name: Filiz CAN, Professor
role: STUDY_CHAIR
affiliation: Cukurova University
name: Ilgen SASMAZ, Professor
role: STUDY_DIRECTOR
affiliation: Acıbadem Adana Hospital
name: Ali Bulent ANTMEN, Professor
role: STUDY_DIRECTOR
References: