Nerve InjuryNCT05080608
Nerve Injury in the Hand, an Interview Study
An observational study of Nerve Injury, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
This qualitative study sought to explore the exerience of change in physical activity due to nerve injury in the arm and hand. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Nerve Injury
- What is being tested?
- Surgery
- How many people
- 25 participants
- Where
- 1 siteSweden
- Study dates
- 1 May 2021to 30 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older 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.
Who may be able to join
- Injury to the median, ulnar or digital nerve or injury to the brachial plexus.
- 1-5 years post injury.
Who cannot join
- Severe psychiatric disease.
- Drug or alcohol abuse.
- Insufficient language understanding.
- Severe diabetes mellitus with nerve complications.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patients´ Experiences of Changed Physical Activity Level Following Nerve Injury in the Upper Limb- a Qualitative Study
This qualitative study sought to explore the exerience of change in physical activity due to nerve injury in the arm and hand.
Read the 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.
- Conditions
- Nerve Injury
- Being tested
- Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryOther
Also called Rehabilitation
Treatment according to clinical practise
| Study group | Role | What they receive |
|---|---|---|
| Nerve injury | This is an interview study of patients with injury to the median, ulnar or digital nerve or brachial plexus injury. Receives: Other: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1-5 years post injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2021
- Study start1 May 2021
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nerve InjuryStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Hand surgery Södersjukhuset
- Responsible party
- Principal investigator, Cecilia Mellstrand Navarro, Karolinska Institutet
- Investigators
- Marianne Arner, Professor, Study director, Karolinska InstitutetCecilia Mellstrand Navarro, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05080608
- Sponsor's protocol ID
- Nerve injury interview
- Status last verified
- Nov 2023
- First submitted
- 4 Oct 2021
- Last updated
- 7 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patients´ Experiences of Changed Physical Activity Level Following Nerve Injury in the Upper Limb- a Qualitative Study
- ClinicalTrials.gov ID
- NCT05080608
- Acronym / sponsor ID
- Nerve injury interview
- Conditions
- Nerve Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Department of Hand surgery Södersjukhuset
- Study start
- 1 May 2021 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 18 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nerve injury | – | Other: SurgeryThis is an interview study of patients with injury to the median, ulnar or digital nerve or brachial plexus injury. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (2 listed)
- Injury to the median, ulnar or digital nerve or injury to the brachial plexus.
- 1-5 years post injury.
Key exclusion criteria (4 listed)
- Severe psychiatric disease.
- Drug or alcohol abuse.
- Insufficient language understanding.
- Severe diabetes mellitus with nerve complications.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurgeryAlso: RehabilitationTreatment according to clinical practise | Other | Nerve injury |
Primary outcome
Interview
Time frame: 1-5 years post injury
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marianne Arner, Professor study director
Karolinska Institutet
Cecilia Mellstrand Navarro, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nerve Injury, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interview (time frame: 1-5 years post injury). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.