To explore whether wearing the orthosis improves the performance of functional activities, additionally to obtain insight in the usability of the orthosis.
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main outcome measure is the Wolf Motor Function Test (WMFT).
Secondary outcome
Action Research Arm Test (ARAT), System Usability Scale (SUS), Motor Activity
Log (MAL), an interview (including *Patiënt Specifieke Klachten (PSK) lijst*)
and a diary in which the use duration per activity will be noted.
Background summary
After a stroke, restoration of hand function often lags behind and the hand is
being used less and less. The MyHand orthosis was developed to support stroke
patients in predominantly hand opening, in order to support and increase the
hand function during daily functional activities. When using such an orthosis,
ultimately support of activities of daily living (ADL) can be integrated with
the ultimate intensive training of task-specific actions: active involvement of
the arm and hand in daily activities.
Study objective
To explore whether wearing the orthosis improves the performance of functional
activities, additionally to obtain insight in the usability of the orthosis.
Study design
Cross-sectional study, consisting of a direct comparison of functional task
performance with and without orthosis on 2 occasions: at first use and after 3
practice sessions within 1 week.
Intervention
All subjects will receive the same intervention: use of a dynamic functional
hand orthosis to support hand function during functional tasks.
Study burden and risks
There is a possibility that the grasping functionality of the hand will improve
during wearing of the orthosis, however this can*t be guaranteed since this is
the objective of the current study. Potential risks for the subjects (e.g.,
discomfort when wearing the orthosis and overexertion) are limited as much as
possible by only applying supervised use of the orthosis and asking only
movements that are within the abilities of the patient, in both the practice
sessions and the evaluation tests.
Roessinghsbleekweg 33b
Enschede 7522 AH
NL
Roessinghsbleekweg 33b
Enschede 7522 AH
NL
Listed location countries
Age
Inclusion criteria
- Time post-stroke at least 4 weeks
- Hemiparesis of arm and hand (Brunnstrom stage 3-4)
- Age between 18 and 80
- Able to complete sessions (at least 3,5h)
- Free from co-morbidity that affects movement of the arm
- Free from fixed contractures in arm and hand
- Mentally competent and able to follow instructrions
Exclusion criteria
- Potential other diseases that affect the wellbeing of the subject and the measurements (such as fever, flu, etc.)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | in aanvraag bij Nederlands Trial Register |
| CCMO | NL57353.044.16 |