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The Effects of Manual Therapy in Hemophilic Patients

Primary Purpose

Hemophilia, Arthropathy Hemophilic

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Manual therapy
Sponsored by
Necmettin Erbakan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemophilia focused on measuring Hemophilia, Arthropathy, Physiotherapy, Manual therapy, Joint health

Eligibility Criteria

18 Years - 30 Years (Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Cukurova University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Manual Therapy

Home Exercise

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Hemophilia Joint Health Score
We used the index point of joints. Score ranged from 0 to 20. Low score indicates the good joint health
Functional Independence Score in Hemophilia
We used the functional independence of patients. Score ranged from 0 to 32. High score indicates the functional independence.
Tampa Kinesiophobia Scale
Score higher than 37 were associated with a high degree of kinesiophobia.

Secondary Outcome Measures

Range of motion
Joint range was measured with a universal goniometer.
Muscle Strength
It was measured with hand-held dynamometer.
Numerical Pain Scale
It was used for assessment of activity and resting pain.
Frequency bleeding
It was evaluated from the diaries kept by the patients
Functional Reach
It was used to assess dynamic balance.
Timed Up and Go
It was used to evaluate functional mobility, dynamic balance, fall risk and postural stability.
5 Times Sit to Stand
It was evaluated the functional strength of lower extremity, transitive movements, balance and fall risk.

Full Information

First Posted
March 13, 2020
Last Updated
March 13, 2020
Sponsor
Necmettin Erbakan University
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1. Study Identification

Unique Protocol Identification Number
NCT04309903
Brief Title
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

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
July 12, 2018 (Actual)
Primary Completion Date
April 15, 2019 (Actual)
Study Completion Date
October 7, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Necmettin Erbakan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemophilia, Arthropathy Hemophilic
Keywords
Hemophilia, Arthropathy, Physiotherapy, Manual therapy, Joint health

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Filiz CAN, Professor
Organizational Affiliation
Hacettepe University, Faculty of Physiotherapy and Rehabilitation
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ilgen SASMAZ, Professor
Organizational Affiliation
Cukurova University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ali Bulent ANTMEN, Professor
Organizational Affiliation
Acıbadem Adana Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Cukurova University
City
Adana
State/Province
Sarıcam
ZIP/Postal Code
01330
Country
Turkey

12. IPD Sharing Statement

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The Effects of Manual Therapy in Hemophilic Patients

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