Examination Chair for Hip Internal Rotation Range of Moti... | NCT02435134

Studies
Examination Chair for Hip Internal Rotation Range of Motion Measurement

NCT02435134

Sponsor

Schulthess Klinik

Status

Completed

Last Update Posted

Feb 14, 2017Actual

Enrollment

30Actual

Phase

Not provided

Conditions

Limited Hip Mobility

Interventions

no intervention

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 7, 2015Actual

Primary Completion Date

Jan 25, 2017Actual

Completion Date

Jan 25, 2017Actual

First Submitted Date

Apr 27, 2015

First Submission Date that Met QC Criteria

May 5, 2015

First Posted Date

May 6, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 13, 2017

Last Update Posted Date

Feb 14, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Hip internal rotation range of motion (HIRROM) assessment is performed to assess the mobility of the hip. The assessment is typically done manually (manual testing), which induces large variability in the results between and within testers. An initial version of an examination chair (EC1) was recently developed with the aim to minimize the variability of testing results for HIRROM assessments. A new version of the examination chair (EC2) has been implemented in order to individualize the testing protocol and will be validated in this study.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Label	Type	Description	Intervention Names
Healthy participants			Other: no intervention

Name	Type	Description	Arm Group Labels	Other Names
no intervention	Other		Healthy participants

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hip internal rotation range of motion angle (degrees)	Participants will be tested for hip internal range of motion using three different methods. The measurements will be repeated 7 days after the initial measurement.	7 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participants are pain free in the lower extremity, hip and back
Participants signed the consent form

Exclusion Criteria:

Participant requires pain relief medication
History of hip surgery
Neuromuscular disorders
Legal incompetence

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Healthy participants

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Schulthess Klinik		Zurich		8008	Switzerland