Multifunctional diagnostic device for lower-limb amputees- Evaluation of the sensor technology

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00026595

Enrollment

Registered

2021-09-27

Start date

2018-09-03

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Participants

Interventions

Group 1: For the evaluation of the sensor technology, the measurement procedures of the diagnostic device (hip muscle strength, joint range of motion and balance measurement) are tested individually.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: At least 18 years and healthy

Exclusion criteria

Exclusion criteria: No acute or recent injuries of the lower extremities

Design outcomes

Primary

Measure	Time frame
For the validity measurement of the individual measurement procedures of the diagnostic device, the test persons are invited to a one-time measurement appointment. The validity of the individual measurement procedures of the diagnostic device (strength, mobility and balance measurement) are determined by comparison with corresponding already established examination procedures. The following output parameters will be analyzed: Maximum torque in hip flexion, extension, abduction and adduction, maximum hip angle in flexion, extension and abduction as well as COP-based parameters from balance diagnostics. The statistical method used is the Limits of Agreement method. For the reliability measurement of the individual measurement procedures of the diagnostic device, the subjects are invited to two appointments (7 days apart). The following parameters will be tested for reliability: Maximum torque in hip flexion, extension, abduction, and adduction, maximum hip angle in flexion, extension, and abduction, and COP-based parameters from balance diagnostics. To statistically test the test-retest reliability, the ICC is used.	—

Measure

Time frame

For the validity measurement of the individual measurement procedures of the diagnostic device, the test persons are invited to a one-time measurement appointment. The validity of the individual measurement procedures of the diagnostic device (strength, mobility and balance measurement) are determined by comparison with corresponding already established examination procedures. The following output parameters will be analyzed: Maximum torque in hip flexion, extension, abduction and adduction, maximum hip angle in flexion, extension and abduction as well as COP-based parameters from balance diagnostics. The statistical method used is the Limits of Agreement method. For the reliability measurement of the individual measurement procedures of the diagnostic device, the subjects are invited to two appointments (7 days apart). The following parameters will be tested for reliability: Maximum torque in hip flexion, extension, abduction, and adduction, maximum hip angle in flexion, extension, and abduction, and COP-based parameters from balance diagnostics. To statistically test the test-retest reliability, the ICC is used.

—

Secondary

Measure	Time frame
In order to test user acceptance of the diagnostic device, a questionnaire is developed which covers the secondary quality criteria of economy, practicability and usefulness. The users can rate the individual criteria in five evaluation levels. The statistical analysis is descriptive.	—

Countries

Germany

Contacts

Public ContactStefanie John

Otto-von-Guericke-Universität Magdeburg Bereich Sportwissenschaft-Lehrstuhl Sport und Technik/Bewegungswissenschaft

Stefanie.John@ovgu.de00493916754941

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026