HemophiliaNCT04308876
Effectiveness of Manual Therapy and Strengthening Exercises in Hemophilic Arthropathy of the Elbow Joint
A study testing Manual therapy and Strengthening exercises in people with Hemophilia and Arthritis, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial summary
Manual treatment involves techniques based on the principles of moving the joint faces and separating the joint gap, and soft tissues mobilization techniques. The use of manual therapy in hemophilia is gradually increasing although it previously described as a contraindication. Read more about this study
- Who is it for?
- Ages 12 to 35 years, men only
- Conditions the study is for
- Hemophilia, Arthritis
- What is being tested?
- Manual therapy and Strengthening exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Apr 2018to 6 Feb 2020
- 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 12 to 35 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Having signs of hemophilic arthropathy in one or both elbow joints, Being between the ages of 12-30 (Adolescent and young adult), Receiving prophylactic factor replacement therapy.
Who cannot join
- Having undergone any surgical procedure for elbow arthropathy, Having an orthopedic problem, such as a fracture, ligament or tendon injury, related to the upper limb in the past year, Receiving physiotherapy and rehabilitation for the elbow joint in the last 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Effectiveness of Manual Therapy and Strengthening Exercises in Physiotherapy and Rehabilitation of Hemophilic Arthropathy of the Elbow
Manual treatment involves techniques based on the principles of moving the joint faces and separating the joint gap, and soft tissues mobilization techniques. The use of manual therapy in hemophilia is gradually increasing although it previously described as a contraindication. The utility and use of strengthening exercises in hemophilia has been going on for a long time. In this study, the effect of manual therapy and strengthening exercises joint was investigated in hemophilic arthropathy of the elbow.
Read the detailed description
The aim of this study was to investigate the effects of strengthening exercises and manual therapy on bleeding frequency, pain, range of motion, muscle strength, arm circumference, joint health, functionality and quality of life in the physiotherapy and rehabilitation of hemophilic arthropathy of the elbow. Seventeen adolescent and young adult hemophilic individuals aged 12-30 years with elbow arthropathy were included in the study. The individuals were divided into the two groups via simple randomisation as Manuel Therapy and Exercise Group (MTEG) and Home Exercise Group (HEG). The individuals in HEG were given strengthening exercises as a home program. Those in the MTEG were applied manual therapy by the physiotherapist and were given supervised strengthening exercises. All treatments were performed 3 times a week for 5 weeks totally 15 sessions. Frequency of bleeding was evaluated with number of bleeding in the last 5 weeks. Numerical Pain Scale was used for activity and resting pain. Range of motion and muscle strength were measured with universal goniometer and digital dynamometer, respectively. The Quick-DASH questionnaire and Oxford Elbow Score were used for the functionality of the upper extremity and quality of life, respectively. The joint health status was evaluated with Hemophilia Joint Health Score-Elbow Point and Hospital for Special Surgery-Elbow Scoring System. Evaluations were made by the same physiotherapist before and after treatment.
- Conditions
- Hemophilia, Arthritis
- Being tested
- Manual therapy, Strengthening exercises
- Keywords
- Hemophilia, Arthropathy, Elbow joint, Manual therapy, Exercise
- Medical subject headings
- Hemophilia A, Arthritis, Joint Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual therapyOther
Manual therapy includes techniques applied to elbow joints and surrounding tissues
Strengthening exercisesOther
Strengthening exercises used in this study includes resistant exercises to increase muscle strength of upper extremity
| Study group | Role | What they receive |
|---|---|---|
| Manual therapy and strengthening exercises | Experimental | Manual therapy and strengthening exercises were applied totally 15 sessions for 5 weeks 3 times a week in hospital by physiotherapist. Receives: Other: Manual therapy; Other: Strengthening exercises |
| Strengthening exercises | Active comparator | Patients in this group performed the strengthening exercises given to the experimental group on their own at home with experimental group at the same time, frequency and dose. Receives: Other: Strengthening exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemophilia Joint Health Score
We used the elbow point of Joint Health Status. Elbow Point is scored 0-20. A high score indicates that arthropathy findings worsen
Measured: 5 week
Frequency of bleeding
It was evaluated wit bleeding number in elbow joint over last 5 week
Measured: 5 week
Numerical Pain Scale
It was used for evaluation of activity and resting pain.
Measured: 5 week
Secondary outcomes (5)
Range of motion
It was measured with universal goniometer.
Measured: 5 week
Muscle strength
It was measured with digital dynamometer (Lafayette hand-held dynamometer)
Measured: 5 week
Functionality of the upper extremity
Quick-Disability of Arm, Shoulder and Hand questionnaire was used.
Measured: 5 week
Oxford Elbow Score
It was used for evaluation of Quality of life.
Measured: 5 week
Physical status of the elbow
Hospital for Special Surgery-Elbow Scoring System was used.
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 start9 Apr 2018
- Primary completion10 Mar 2019
- Study completion6 Feb 2020
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, Ayse Merve Tat, Necmettin Erbakan University
- Investigators
- Filiz Can, Professor, Study chair, Hacettepe University, Faculty of Physical TherapyIlgen Sasmaz, Study director, Cukurova University, Faculty of Medicine, Department of Pediatric Hematology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04308876
- Sponsor's protocol ID
- Necmettin Erb. Physiotherapy-1
- Status last verified
- Mar 2020
- First submitted
- 12 Mar 2020
- Last updated
- 16 Mar 2020
- Results posted
- 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
- Investigation of Effectiveness of Manual Therapy and Strengthening Exercises in Physiotherapy and Rehabilitation of Hemophilic Arthropathy of the Elbow
- ClinicalTrials.gov ID
- NCT04308876
- Acronym / sponsor ID
- Necmettin Erb. Physiotherapy-1
- Conditions
- Hemophilia, Arthritis
- Keywords
- Hemophilia, Arthropathy, Elbow joint, Manual therapy, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 9 Apr 2018 (actual)
- Primary completion
- 10 Mar 2019 (actual)
- Study completion
- 6 Feb 2020 (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.
Manual treatment involves techniques based on the principles of moving the joint faces and separating the joint gap, and soft tissues mobilization techniques. The use of manual therapy in hemophilia is gradually increasing although it previously described as a contraindication. The utility and use of strengthening exercises in hemophilia has been going on for a long time. In this study, the effect of manual therapy and strengthening exercises joint was investigated in hemophilic arthropathy of the elbow.
Detailed description
The aim of this study was to investigate the effects of strengthening exercises and manual therapy on bleeding frequency, pain, range of motion, muscle strength, arm circumference, joint health, functionality and quality of life in the physiotherapy and rehabilitation of hemophilic arthropathy of the elbow. Seventeen adolescent and young adult hemophilic individuals aged 12-30 years with elbow arthropathy were included in the study. The individuals were divided into the two groups via simple randomisation as Manuel Therapy and Exercise Group (MTEG) and Home Exercise Group (HEG). The individuals in HEG were given strengthening exercises as a home program. Those in the MTEG were applied manual therapy by the physiotherapist and were given supervised strengthening exercises. All treatments were performed 3 times a week for 5 weeks totally 15 sessions. Frequency of bleeding was evaluated with number of bleeding in the last 5 weeks. Numerical Pain Scale was used for activity and resting pain. Range of motion and muscle strength were measured with universal goniometer and digital dynamometer, respectively. The Quick-DASH questionnaire and Oxford Elbow Score were used for the functionality of the upper extremity and quality of life, respectively. The joint health status was evaluated with Hemophilia Joint Health Score-Elbow Point and Hospital for Special Surgery-Elbow Scoring System. Evaluations were made by the same physiotherapist before and after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual therapy and strengthening exercises | Experimental | Other: Manual therapy, Other: Strengthening exercisesManual therapy and strengthening exercises were applied totally 15 sessions for 5 weeks 3 times a week in hospital by physiotherapist. |
| Strengthening exercises | Active comparator | Other: Strengthening exercisesPatients in this group performed the strengthening exercises given to the experimental group on their own at home with experimental group at the same time, frequency and dose. |
Who may qualify
- Ages
- 12 to 35 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Having signs of hemophilic arthropathy in one or both elbow joints, Being between the ages of 12-30 (Adolescent and young adult), Receiving prophylactic factor replacement therapy.
Key exclusion criteria (1 listed)
- Having undergone any surgical procedure for elbow arthropathy, Having an orthopedic problem, such as a fracture, ligament or tendon injury, related to the upper limb in the past year, Receiving physiotherapy and rehabilitation for the elbow joint in the last 6 months
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 therapyManual therapy includes techniques applied to elbow joints and surrounding tissues | Other | Manual therapy and strengthening exercises |
| Strengthening exercisesStrengthening exercises used in this study includes resistant exercises to increase muscle strength of upper extremity | Other | Manual therapy and strengthening exercises, Strengthening exercises |
Primary outcome
Hemophilia Joint Health Score
Time frame: 5 week
We used the elbow point of Joint Health Status. Elbow Point is scored 0-20. A high score indicates that arthropathy findings worsen
Frequency of bleeding
Time frame: 5 week
It was evaluated wit bleeding number in elbow joint over last 5 week
Numerical Pain Scale
Time frame: 5 week
It was used for evaluation of activity and resting pain.
5 secondary outcomes
Range of motion
Time frame: 5 week
Muscle strength
Time frame: 5 week
Functionality of the upper extremity
Time frame: 5 week
Oxford Elbow Score
Time frame: 5 week
Physical status of the elbow
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 Physical Therapy
Ilgen Sasmaz study director
Cukurova University, Faculty of Medicine, Department of Pediatric Hematology
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 and Strengthening exercises in people with Hemophilia and Arthritis, 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.