The Effects of Manual Therapy in Hemophilic Patients

NCT04309903 | Completed

• 1 other identifier: Necmettin Erb. Physiotherapy-2
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemophilia; Arthropathy Hemophilic

Keywords

Hemophilia; Arthropathy; Physiotherapy; Manual therapy; Joint health

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• Tampa Kinesiophobia Scale

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

  5 week

Secondary Outcomes (7)

• Range of motion

  5 week

• Muscle Strength

  5 week

• Numerical Pain Scale

  5 week

• Frequency bleeding

  5 week

• Functional Reach

  5 week

Study Arms (2)

Manual Therapy

EXPERIMENTAL

The experienced physiotherapist has applied manual therapy (MT) to the arthropathic joints. MT was started with myofascial release techniques (MRT), then continued with mobilization techniques using Kalternborn. Superficial MRT consisted of 3 strokes, via manual movement on the tissue, encourage release of the superficial fascia. In the Kalternborn mobilization technique, Grade I-II mobilization was applied with traction without using a strap. The same exercises given to the home exercise group were given to the patients in this group as well.

Other: Manual therapy

Home Exercise

ACTIVE COMPARATOR

The home exercises (HE) consisted of active ROM exercises, passive stretching exercises, progressive resistive exercises, weigh-bearing and stance exercises were performed by the patient for 30 minutes at home.

Other: Manual therapy

Interventions

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.

Also known as: Home exercise

Home Exercise; Manual Therapy

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Necmettin Erbakan University: lead

Study Sites (1)

Cukurova University

Adana, Sarıcam, 01330, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hemophilia A; Joint Diseases

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Filiz CAN, Professor

  Hacettepe University, Faculty of Physiotherapy and Rehabilitation

  STUDY CHAIR

• Ilgen SASMAZ, Professor

  Cukurova University

  STUDY DIRECTOR

• Ali Bulent ANTMEN, Professor

  Acıbadem Adana Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: March 13, 2020
• First Posted: March 16, 2020
• Study Start: July 12, 2018
• Primary Completion: April 15, 2019
• Study Completion: October 7, 2019
• Last Updated: March 16, 2020

Record last verified: 2020-03

Locations

TU (1)