E83.38
Conditions
Interventions
Group 1: Single arm study for adult patients with HPP who recieve an activity tracker for 3x2 weeks to analyze daily activity levelsat home
Sponsors
Klinische Studieneinheit König Ludwig Haus
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Confirmed clinical diagnosis of HPP based on one of the following: - ALP activity (age- and gender-adjusted) below lower limit of normal, measured at least two times within a minimum four-week interval - Genetic confirmation of the disease by documented variant within the ALPL Gene - Experience HPP-associated functional deficits requiring professional treatment (ie. Pain medication, physiotherapy) - Elevated substrates above upper limit of normal for PLP and/or urinary PEA - Symptoms of the disease
Exclusion criteria
Exclusion criteria: - Inability to walk, or require the use of assistive devices for walking - Regular use of a wheelchair even for distances < 50m - Inability / unwillingness to comply with repeated testing requirements and wearing the activity tracking device - Currently enrolled in another clinical trial - Patient on enzyme replacement therapy with asfotase alfa
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the feasibility of and the adherence to activity tracking by utilizing a wearable tracking device in patients with hypophosphatasia. Data will be collected via activity tracker which will be worn 3x2 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the validity and reliability of activity tracking using a wearable device in patients with hypophosphatasia. | — |
Countries
Germany
Contacts
Public ContactLothar Seefried
Klinische Studieneinheit König Ludwig Haus
Outcome results
None listed