Nerve Injury in the Hand, an Interview Study | NCT05080608

Studies
Nerve Injury in the Hand, an Interview Study

NCT05080608

Sponsor

Karolinska Institutet

Status

Unknown status

Last Update Posted

Nov 7, 2023Actual

Enrollment

25Estimated

Phase

Not provided

Conditions

Nerve Injury

Interventions

Surgery

Countries

Sweden

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

Nov 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2021Actual

Primary Completion Date

Apr 30, 2024Estimated

Completion Date

Apr 30, 2024Estimated

First Submitted Date

Oct 4, 2021

First Submission Date that Met QC Criteria

Oct 4, 2021

First Posted Date

Oct 18, 2021Actual

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

Nov 6, 2023

Last Update Posted Date

Nov 7, 2023Actual

Name	Class
Department of Hand surgery Södersjukhuset	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

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

This qualitative study sought to explore the exerience of change in physical activity due to nerve injury in the arm and hand.

Detailed Description

Aim:

Has the physical activity level changed in connection with the nerve injury. Experiences of factors influensing this change.

Population: Patients surgically treated for digital,median,ulnar-or plexus nerveinjuries at Södersjukhuset or Universitets sjukhuset in Linköping. 1-3 years ago. Age 18-75.

Method: Interviews are carried out over the phone, digitally recorded and trascribed. The analysis is inductive approach.

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

25Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nerve injury		This is an interview study of patients with injury to the median, ulnar or digital nerve or brachial plexus injury.	Other: Surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Surgery	Other	Treatment according to clinical practise	Nerve injury

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Interview	A semi structured interview will be conducted, utilizing semi structured interview. Themes regarding changes in physical activity related to the nerve injury will be presented.	1-5 years post injury

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Injury to the median, ulnar or digital nerve or injury to the brachial plexus.
1-5 years post injury.

Exclusion Criteria:

Severe psychiatric disease.
Drug or alcohol abuse.
Insufficient language understanding.
Severe diabetes mellitus with nerve complications.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Patients treated surgically due to Injury to the median, ulnar or digital nerve or injury to the brachial plexus. 1-5 years post injury.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marianne Arner, Professor	Karolinska Institutet	Study Director
Cecilia Mellstrand Navarro, PhD	Karolinska Institutet	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Karolinska institutet södersjukhuset		Stockholm		11883	Sweden

Intervention Browse Module

MeSH Terms

ID	Term
D013514	Surgical Procedures, Operative
D012046	Rehabilitation

Ancestor Terms

ID	Term
D000359	Aftercare
D003266	Continuity of Patient Care
D005791	Patient Care
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided