To gain insight into the measurement properties of three questionnaires (part I) and the measurement properties of the upper limb functional capacity evaluation (part II). To gain insight in the effects of disorders of hand or wrist on health-…
ID
Source
Brief title
Condition
- Muscle disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Each 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 outcome
Part 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).
Background summary
Upper limb disorders frequently occur and cause symptoms and disability.
Several instruments to assess symptoms and disability in patients with upper
extremity problems are available, such as questionnaires and Functional
Capacity Evaluation. Measurement properties of those instruments have not been
properly assessed in (Dutch) patients with (non)specific complaints of the
hand or wrist. Furthermore, upper limb disorders are related to lower levels of
self-reported physical fitness. It is unknown if objectively measured physical
fitness is also reduced.
Study objective
To gain insight into the measurement properties of three questionnaires (part
I) and the measurement properties of the upper limb functional capacity
evaluation (part II). To gain insight in the effects of disorders of hand or
wrist on health-related physical fitness (part III).
Study design
The study design is an observational study with three parts:
Part I. Assessing measurement properties (internal consistency, construct
validity, reproducibility, responsiveness and floor or ceiling effects) of
Dutch language versions of three questionnaires (QuickDASH, PRWHE, HFS).
Part II. Assessing measurement properties (construct validity and
reproducibility) of a (comprehensive) upper extremity functional capacity
evaluation (FCE).
Part III. Assessing health-related physical fitness.
Depending on inclusion/exclusion criteria and informed consent, a patient might
participate in one or more parts of the study.
Study burden and risks
Part I: Fill out three questionnaires at two (or three in case of hand therapy)
times, no risks.
Part II: Visit the University Medical Center Groningen at two times to fill out
three questionnaires and perform the FCE. Participants risk a temporary
increase in symptom intensity/muscle soreness the day(s) following FCE.
Part III: Single visit to the University Medical Center Groningen to perform
cardiopulmonary exercise testing. Participants risk a temporary increase in
symptom intensity/muscle soreness the day(s) following exercise testing. The
risk of medical complications is very low and further minimized by careful
screening procedures.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion 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).
Exclusion criteria
- Insufficient understanding of Dutch to fill out questionnaires.
- Other medical condition(s) causing considerate disability.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL51584.042.15 |