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Measuring symptoms and disability in hand/wrist disorders.


- candidate number24238
- NTR NumberNTR5792
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR15-apr-2016
- Secondary IDsNL51584.042.15 
- Public TitleMeasuring symptoms and disability in hand/wrist disorders.
- Scientific TitleAspecific Complaints of the Arm: Demonstration and Evaluation of Measurement Instruments (ACADEMI).
- ACRONYMACADEMI
- hypothesis
- Healt Condition(s) or Problem(s) studiedUpper extremity, Disability
- Inclusion criteriaIn order to be eligible to participate in this study (part I, II and III), a subject must meet all of the following criteria:
- Aged 18 years or over.
- Complaints of hand, wrist and/or forearm, classified as either specific or nonspecific complaints of the arm, neck and/or shoulder (CANS), which might have a direct influence on hand or wrist function (in practice all complaints located from the elbow towards the fingers).

Extra for assessing responsiveness in part I:
- Receiving hand therapy for these complaints at the outpatient clinic of the Department of Rehabilitation Medicine of the University Medical Center Groningen, for a duration of at least four weeks.

Extra for the functional capacity evaluation study (part II):
- Meeting the criteria of the Physical Activity Readiness Questionnaire (PAR-Q). If question 5 (‘Do you have a bone or joint problem that could be made worse by a change in your physical activity’) is solely answered with ‘yes’ because of those complaints of hand, wrist and/or forearm for which the patient visited the outpatient clinic of the Department of Rehabilitation Medicine of the University Medical Center Groningen, we consider the criteria of the PAR-Q are still being met.
- Exclusion criteriaA potential subject who meets any of the following criteria will be excluded from participation in this study (parts I, II and III):
- Insufficient understanding of Dutch to fill out questionnaires.
- Other medical condition(s) causing considerate disability, such as neurological disorders (e.g. stroke, peripheral nerve damage) or joint diseases (e.g. osteoarthritis, rheumatoid arthritis).

Extra for part III:
- Presence of contraindications for cardiopulmonary exercise testing. This is checked using usual clinical criteria, based on the ATS/ACCP Statement on cardiopulmonary exercise testing.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytype[default]
- planned startdate 1-aug-2015
- planned closingdate1-aug-2018
- Target number of participants434
- InterventionsN/A
- Primary outcomeEach part (I, II and III) of the study has its own main study parameters.
Part I. Scores of single items, subscales and a total score of three questionnaires (QuickDASH, PRWHE, HFS).
Part II. Scores of eight different tests composing the upper extremity FCE.
Part III. Maximal oxygen uptake (VO2max in l/min).
- Secondary outcomePart I. Scores of single items, subscales and a total score of the RAND-36, Pain Disability Index (PDI), Pain Numeric Rating Scale, Upper Extremity Work Demands (UEWD). External criterium for assessing responsiveness, after hand therapy: global rating scale (global perceived effect of change).
Part II. Scores of single items, subscales and a total score of three questionnaires (QuickDASH, PRWHE, HFS). Scores of single items, subscales and a total score of the RAND-36, Pain Disability Index (PDI), Pain Numeric Rating Scale, Upper Extremity Work Demands (UEWD).
Part III. Scores of single items, subscales and a total score of three questionnaires (QuickDASH, PRWHE, HFS). Scores of single items, subscales and a total score of the RAND-36, Pain Disability Index (PDI), Pain Numeric Rating Scale, Upper Extremity Work Demands (UEWD). Anaerobic threshold (AT, % of VO2max), W/kg. Handheld dynamometry of both hands. Weight, height, BMI, fat free mass (bio-impedance).
- TimepointsPart I: T1 (first measurement), T2 (1-3 weeks after T1), T3 (4-8 weeks after start of hand therapy, where applicable).
Part II: T1 (first measurement), T2 (1-3 weeks after T1), T3 (4-8 weeks after start of hand therapy, where applicable).
Part III: T1 (first measurement).
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES R.J. Berduszek
- CONTACT for SCIENTIFIC QUERIES R.J. Berduszek
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG)
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD15-apr-2016 - 28-mei-2016


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