Purpose of this study is to assess the feasibility, tolerability of a short thumb opposition splint and the initial efficacy of this splint on manual dexterity and perceived limitations in activities in patients with HMSN1a. Additionally, the…
ID
Source
Brief title
Condition
- Peripheral neuropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Manual dexterity assessed with the Sollerman hand function test. The Sollerman
test consists of 20 unilateral and bilateral subtests, each comprising a task
considered to be an activity of daily living. The tasks reflect the most common
handgrips used in daily life. The time necessary to perform the task and the
quality of movement of the hand are recorded (test administration time 30-60
min).
Secondary outcome
Manual dexterity assessed with the Functional Dexterity test (FDT). The FDT
provides information regarding the patient's ability to use the hand for
functional daily tasks that require a 3-jaw-chuck prehension between the
fingers and the thumb. An advantage of this test is that it requires a minimum
amount of time for administration (15 seconds to 2 minutes).
Perceived physical functioning of the upper extremity, assessed using the Dutch
language version of the Michigan Hand Outcomes Questionnaire (MHOQ-DLV). The
MHOQ is a self-administered questionnaire. The mean time required to complete
the questionnaire is 10 minutes.
Occupational performance assessed with the Canadian Occupational Performance
Measure (COPM). The COPM is a measure of a client*s self-perception of
occupational performance in the areas of self-care, productivity and leisure.
Outcome measures of the COPM are: client*s most important problems in
occupational performance and a total score for performance and a total score
for satisfaction for these problems.
Perceived usability of the splint will be assessed with a questionnaire
specifically designed for the purpose of the study.
Background summary
Hereditary motor and sensory neuropathy (HMSN) also known as
Charcot-Marie-Tooth disease type, forms a heterogeneous group of slowly
progressive diseases of the peripheral nerve. HMSN presents with distal muscle
weakness and atrophy usually starting in the foot and leg muscles. In a later
stage the hand may be affected. Although in the literature and clinical
practice the attention lies predominantly on the problems of the lower
extremity, many HMSN patients present with affected hand function, loss of
manual dexterity and perceived limitations in upper extremity related
activities.
In our society people value the use of their hands and loss of hand function
may have a substantial effect on their lives. Manual dexterity is furthermore
of utmost importance for daily activities. Previous study has showed that the
ability to oppose the thumb is a major determinant of impaired manual
dexterity. This finding helps target intervention strategies like the use of a
short thumb opponens splint to improve manual dexterity and preserve or enhance
daily life functioning of patients with HMSN.
Study objective
Purpose of this study is to assess the feasibility, tolerability of a short
thumb opposition splint and the initial efficacy of this splint on manual
dexterity and perceived limitations in activities in patients with HMSN1a.
Additionally, the responsiveness of the 3-item version of the Sollerman test
and its associations with hand function and perceived limitations in upper
extremity related activities of patients with HMSN1a are assessed.
Study design
a prospective self-controlled experimental study
Intervention
The intervention consists of a custom made short thumb opponens splint for the
dominant hand. Patients will wear the splint during 6 weeks.
Study burden and risks
Participants will visit the department of Rehabilitation of the AMC 3 times.
During the first visit, manual dexterity will be assessed with 2 different
tests, questionnaires will be administered and in a semi-structured interview
problems in daily activities will be inventoried. The splint will be made and
instructions for use will be given to the participant.
One week after the first visit, the fitting of the splint will be checked and
if necessary the splint will be adapted. During the third visit (after 6 weeks)
manual dexterity with the use of the splint will be assessed and the
questionnaires will be administered. A potential risk of wearing the thumb
opponens splint is the occurence of pressure ulcers. During the second visit,
this will be monitored and in case of a pressure ulcer the splint will be
readapted.
Postbus 22660
1100 DD Amsterdam
Nederland
Postbus 22660
1100 DD Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
Diagnosis of HMSN confirmed by DNA or electrophysiological study;
Age between 18 and 70 years;
Loss of opposition (kapandji score < 3)
Impaired manual dexterity (Sollerman test score <80)
Exclusion criteria
Other disabling disorders in the medical history that might influence hand function of the dominant hand;
Difficulty comprehending the Dutch language;
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL21464.018.08 |