The Effects of Manual Therapy in Hemophilic Patients

Hemophilia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04309903
• Other study ID #: Necmettin Erb. Physiotherapy-2
• Status: Completed
• Phase: N/A
• Start date: July 12, 2018
• Est. completion date: October 7, 2019

Study information

• Verified date: March 2020
• Source: Necmettin Erbakan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: October 7, 2019
• Est. primary completion date: April 15, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthropathy Hemophilic
• Hemophilia
• Hemophilia A
• Joint Diseases

Intervention

Other:
• Manual therapy
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.

Locations

Country	Name	City	State
Turkey	Cukurova University	Adana	Saricam

Sponsors (1)

Lead Sponsor	Collaborator
Necmettin Erbakan University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemophilia Joint Health Score	We used the index point of joints. Score ranged from 0 to 20. Low score indicates the good joint health	5 week
Primary	Functional Independence Score in Hemophilia	We used the functional independence of patients. Score ranged from 0 to 32. High score indicates the functional independence.	5 week
Primary	Tampa Kinesiophobia Scale	Score higher than 37 were associated with a high degree of kinesiophobia.	5 week
Secondary	Range of motion	Joint range was measured with a universal goniometer.	5 week
Secondary	Muscle Strength	It was measured with hand-held dynamometer.	5 week
Secondary	Numerical Pain Scale	It was used for assessment of activity and resting pain.	5 week
Secondary	Frequency bleeding	It was evaluated from the diaries kept by the patients	5 week
Secondary	Functional Reach	It was used to assess dynamic balance.	5 week
Secondary	Timed Up and Go	It was used to evaluate functional mobility, dynamic balance, fall risk and postural stability.	5 week
Secondary	5 Times Sit to Stand	It was evaluated the functional strength of lower extremity, transitive movements, balance and fall risk.	5 week