The objectives of the study are:1) To evaluate the prevalence of secondary impairments and to evaluate the limitations in activities related to severity of impairments and restritions in participation in leprosy patients in the Netherlands.2) To…
ID
Source
Brief title
Condition
- Peripheral neuropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
First part of the study: Survey
1. Impairments questionnaire
2. Impact on participation and autonomy questionnaire (IPA)
3. WHO-DAS II (impairments)
Second part of the study: subgroup analysis
1. Walking capacity (6 minute walking test)
2. Barefoot plantar footpressure
3. History of foot ulceration
Secondary outcome
Second part of the study: subgroup analysis
1. Clinical assessment to confirm neuropathic foot and inclusion/exclusion
criteria
2. Demographics
3. CIRS questionnaire (co morbidity)
4. Foot examinatin (mobility, deformities)
5. In-shoe plantar pressure
6. 7 day walking activity
7. Footwear use
Background summary
Leprosy results in autonomic, sensory and motor neuropathy, which can lead to
the development of secondary impairments such as skin lesions (ulcers, blisters
and burns), hand and foot deformities (clawing of toes and fingers, absorption
of digits and neuro-osteoarthropathy) and eye lesions. As a result of
impairments, many people experience limitation of activities en experience
restrictions in their participation in society.
Although multi-drug therapy has reduced the number of leprosy patients
developing impairments, many patients both on treatment and released from
(drug) treatment have and often continue to have impairments of the foot, and
are still walking around on neuropathic ulcerated feet. Plantar ulcers are well
recognized as a major cause of disability in leprosy. Foot ulcers can lead to
complications such as cellulitis and osteomyelitis and subsequently increase
the risk of amputation. However, this is preventable through the use of
appropriate footwear and preventative foot management. Much time and money is
spent on foot care that could have been prevented by early detection and more
effective care. To date the effect of leprosy on limitations of activities in
westernized coutnries has been a neglected (research) area. Futhermore,
research into the role of foot biomechanics and the riskfactors of increased
plantar pressure in the neuropathic foot in leprosy patients has been often
observational and limited. Additionally, the effect of footwear on plantar
pressure and the effect of daily activity on accumulative stress on the foot
has received no or very limited attention to date.
Study objective
The objectives of the study are:
1) To evaluate the prevalence of secondary impairments and to evaluate the
limitations in activities related to severity of impairments and restritions in
participation in leprosy patients in the Netherlands.
2) To explore the association between severity of impairments, walking
capacity, walking activity and limitations in activities in leprosy paitents
with neuropathic foot impairments.
3) To identify which impairments are determinants of increased plantar pressure
in leprosy patients with foot impairments.
4) To identify which footpressure parameters are the best determinants of foot
ulceration.
Study design
A cross-sectional questionnaire survey and in a subgroup a detailed
observational study
Study burden and risks
The study participants with a neuropathic foot as a consequence of leprosy will
visit the department of rehabilitation AMC twice. During the first visit they
will performa walking test and a clinical examination is performed and
questions about health are asked. Additionally the patient is given a step
activity monitor and is asked to wear this for 7 consecutive days (untill the
2nd visit). During the second visit the footpressure assessments will be done
and the stepactivity moniotr is given back to the researcher.
There are no risks attached to the performance of the walking tests and the
foot pressure measurements. Between de walking test sufficient rest periods
will be given to the participants.
Meibergdreef 9, Postbus 22660
1100 DD Amsterdam
Nederland
Meibergdreef 9, Postbus 22660
1100 DD Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
1) Diagnosis of Leprosy
2) Having attended the Tropical Dermatology outpatient Clinic at the AMC within the last 15 years
3) Age >18 yrs;Additional in criteria for detailed foot analysis
Inclusion criteria:
1) Peripheral neuropathy (for patients attending for detailed foot analysis)
Exclusion criteria
1. Diabetes mellitus
2. Co-morbid disease with significant limited walking ability, including COPD, significant cardiovascular disease, vaso-occlusive diseases, hemiplegia, arthroplasty and sciatica
3. Osteomyelitis or infection of the neuropathic foot (ulcer)
4. Acute neuro-osteoarthropathy
5. Inability to walk (walking aids are permitted as long as foot pressure measurements can be assessed)
Design
Recruitment
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 |
|---|---|
| CCMO | NL12920.018.06 |