HemophiliaNCT04309903
The Effects of Manual Therapy in Hemophilic Patients
A study testing Manual therapy in people with Hemophilia and Arthropathy Hemophilic, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men only
- Conditions the study is for
- Hemophilia, Arthropathy Hemophilic
- What is being tested?
- Manual therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Jul 2018to 7 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Manual Theraphy on Lower Extremity Joint Arthropathy in Patients With Hemophilia
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.
Read the 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.
- Conditions
- Hemophilia, Arthropathy Hemophilic
- Being tested
- Manual therapy
- Keywords
- Hemophilia, Arthropathy, Physiotherapy, Manual therapy, Joint health
- Medical subject headings
- Hemophilia A, Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual therapyOther
Also called Home exercise
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Manual therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemophilia Joint Health Score
We used the index point of joints. Score ranged from 0 to 20. Low score indicates the good joint health
Measured: 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.
Measured: 5 week
Tampa Kinesiophobia Scale
Score higher than 37 were associated with a high degree of kinesiophobia.
Measured: 5 week
Secondary outcomes (7)
Range of motion
Joint range was measured with a universal goniometer.
Measured: 5 week
Muscle Strength
It was measured with hand-held dynamometer.
Measured: 5 week
Numerical Pain Scale
It was used for assessment of activity and resting pain.
Measured: 5 week
Frequency bleeding
It was evaluated from the diaries kept by the patients
Measured: 5 week
Functional Reach
It was used to assess dynamic balance.
Measured: 5 week
Timed Up and Go
It was used to evaluate functional mobility, dynamic balance, fall risk and postural stability.
Measured: 5 week
5 Times Sit to Stand
It was evaluated the functional strength of lower extremity, transitive movements, balance and fall risk.
Measured: 5 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2020
- Study start12 Jul 2018
- Primary completion15 Apr 2019
- Study completion7 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemophiliaStudies of the same condition, open and under way.
- More trials run by Necmettin Erbakan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Necati Muhammed TAT, Necmettin Erbakan University
- Investigators
- Filiz CAN, Professor, Study chair, Hacettepe University, Faculty of Physiotherapy and RehabilitationIlgen SASMAZ, Professor, Study director, Cukurova UniversityAli Bulent ANTMEN, Professor, Study director, Acıbadem Adana Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04309903
- Sponsor's protocol ID
- Necmettin Erb. Physiotherapy-2
- Status last verified
- Mar 2020
- First submitted
- 13 Mar 2020
- Last updated
- 16 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Manual Theraphy on Lower Extremity Joint Arthropathy in Patients With Hemophilia
- ClinicalTrials.gov ID
- NCT04309903
- Acronym / sponsor ID
- Necmettin Erb. Physiotherapy-2
- Conditions
- Hemophilia, Arthropathy Hemophilic
- Keywords
- Hemophilia, Arthropathy, Physiotherapy, Manual therapy, Joint health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 12 Jul 2018 (actual)
- Primary completion
- 15 Apr 2019 (actual)
- Study completion
- 7 Oct 2019 (actual)
- First posted
- 16 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual Therapy | Experimental | Other: Manual therapyThe 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. |
| Home Exercise | Active comparator | Other: Manual therapyThe 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual therapyAlso: Home exerciseBoth 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 | Home Exercise, Manual Therapy |
Primary outcome
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
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.
Tampa Kinesiophobia Scale
Time frame: 5 week
Score higher than 37 were associated with a high degree of kinesiophobia.
7 secondary outcomes
Range of motion
Time frame: 5 week
Muscle Strength
Time frame: 5 week
Numerical Pain Scale
Time frame: 5 week
Frequency bleeding
Time frame: 5 week
Functional Reach
Time frame: 5 week
Timed Up and Go
Time frame: 5 week
5 Times Sit to Stand
Time frame: 5 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Filiz CAN, Professor study chair
Hacettepe University, Faculty of Physiotherapy and Rehabilitation
Ilgen SASMAZ, Professor study director
Cukurova University
Ali Bulent ANTMEN, Professor study director
Acıbadem Adana Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual therapy in people with Hemophilia and Arthropathy Hemophilic, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemophilia Joint Health Score (time frame: 5 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2020.