search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Measurement of gait variability in patients with and without hemophilic arthropathy; MOVE study


- candidate number16416
- NTR NumberNTR4561
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR13-feb-2014
- Secondary IDsMEC-2014-086 MEC
- Public TitleMeasurement of gait variability in patients with and without hemophilic arthropathy; MOVE study
- Scientific TitleMeasurement of gait variability in patients with and without hemophilic arthropathy; MOVE study
- ACRONYMMOVE study
- hypothesis- A new sensorbased gait analysis measurement as a simple and quick diagnostic/monitoring tool to evaluate joint status and changes in gait pattern in hemophilia patients.
- Possibility to detect a disturbed gait pattern in clinically asymptomatic patients (HJHS=0)
- Healt Condition(s) or Problem(s) studiedHaemophilia, Gait pattern, Arthropathy
- Inclusion criteria− Patients with mild, moderate or severe hemophilia A or B
− Age >12 years
− No clinical evidence of a recent joint or muscle bleed; no joint or muscle bleed at least 30 days prior to inclusion
- Exclusion criteria− Inability to walk 20 meters without use of assistive devices
− Joint replacement in knee, ankle or hip
− Arthrodesis of foot and ankle joints
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-apr-2014
- planned closingdate1-jul-2015
- Target number of participants100
- InterventionsGait analysis with a new, simple and quick device. The six sensors of this system will be mounted on both sides of the hip, on the lateral side of the lower limbs using straps around thigh (just below the greater trochanter) and calf (at the level of the belly of the gastrocnemius muscle). Each patient will be asked to walk at least 20 meters on his own shoes, on standardized shoes and barefoot (grip socks for hygiene). The analysis of the walking test will be done using dedicated software. The analysis will be performed on the section of the walking test where the patient is walking steadily for at least 7 strides.
A physiotherapist specialized in hemophilia care will assess the Hemophilia Joint Health Score (HJHS) on the same day as the walking test. The results of the walking test will not be available to the physiotherapist and the HJHS assessment will not be available to the walking test executive. Baseline data, data on hemophilia and joint history will be obtained by using questionnaires and patient history.
- Primary outcomeDisturbed gait pattern detected with sensor based gait analysis system, defined as % of difference in range of motion, quality of gait and symmetry of gait compared to the reference population.
- Secondary outcome− Number (%) of patients with Hemophilia Joint Health Score=0 and a disturbed gait pattern as defined above.
− Differences in outcome parameters of the gait analysis barefoot, on standardized walking shoes and on own shoes.
- TimepointsBecause of the cross-sectional design of this study, every patient will be measured once. No follow-up intended.
- Trial web site
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESDrs. S.C.M. Stoof
- CONTACT for SCIENTIFIC QUERIESDr. M.J.H.A. Kruip
- Sponsor/Initiator Erasmus Medical Center, Sophia Children's Hospital
- Funding
(Source(s) of Monetary or Material Support)
Pfizer
- PublicationsN/A
- Brief summaryPROBLEM DEFINITION: Musculoskeletal assessment is necessary to evaluate efficacy of coagulation factor replacement therapy in hemophilia. Most current tools do not integrate the global impact of multiple-joint arthropathy or muscle bleeds. A new and simple sensor based gait analysis device measures and detects changes in gait pattern. This can serve as a screening tool in hemophilia patients with and without arthropathy.
OBJECTIVE: To establish whether this system can be used to detect gait abnormalities in hemophilia patients
STUDY DESIGN: Single-center cross sectional observational study
STUDY POPULATION: Hemophilia A or B patients with all severities
FEASIBILITY OF THE PROJECT: With 300 hemophilia patients in our Hemophilia Treatment Center and an annual visit of each patient, more than 100 patients can be included.
RELEVANCE FOR CLINICAL PRACTICE
A. CONCRETE REVENUES:
1. Simple and quick diagnostic and monitoring tool to evaluate joint status
2. Possibility to detect a disturbed gait in clinically asymptomatic patients
B. IMPLEMENTATION OF RESULTS:
If this sensor based gait analysis system shows to be an effective tool, we plan to implement this type of gait analysis in our regular hemophilia care; i.e. annual analysis.
- Main changes (audit trail)
- RECORD13-feb-2014 - 23-feb-2015


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl