Nerve InjuryNCT05611983
Experience and Feasibility of Methods for Early Sensory Training
A study testing sensory relearning in people with Nerve Injury and Peripheral Nerve Injuries, run by Lund University Hospital at 1 site in Sweden.
Trial summary
The good effects of using guided plasticity for a rehabilitative purpose in case of nerve damage have been shown, but a problem that has been presented is that some individuals find it difficult to assimilate these effects due to difficulties in carrying out abstract training or due to a lack of motivation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nerve Injury, Peripheral Nerve Injuries
- What is being tested?
- sensory relearning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jun 2022to 1 Jun 2024
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >= 50% injury of N. Medianus/ N. Ulnaris or 100% digital nerve injury dig I and/or dig II
- Ålder: ≥ 18 år
Who cannot join
- Impaired cognitive ability
- Documented psychiatric diagnosis
- Inability to master the Swedish language
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Skane university hospital
Malmö, Skåne County, 20502
Ulrika Wijk, +4640331744, ulrika.wijk@med.lu.se
About this study
Official title: Experience and Feasibility of Methods for Early Sensory Training Phase 1 - From a User Perspective
The good effects of using guided plasticity for a rehabilitative purpose in case of nerve damage have been shown, but a problem that has been presented is that some individuals find it difficult to assimilate these effects due to difficulties in carrying out abstract training or due to a lack of motivation. In early sensory training, the plasticity of the brain is used. Methods for early sensory training that have been described are: 1) mental imagery of touch (mental imagery), 2) observation of touch, 3) mirror training, 4) use of images for visualization of touch. The method needs to be developed and refined to be able to offer individual training plans in order to find a motivating and meaningful form of training.
- Conditions
- Nerve Injury, Peripheral Nerve Injuries
- Being tested
- sensory relearning
- Keywords
- periferal nerve injuries, sensory relearning, rehabilitation, imagery, mirror therapy
- Medical subject headings
- Peripheral Nerve Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sensory relearningBehavioural
feasibility of early sensory relearning
| Study group | Role | What they receive |
|---|---|---|
| Observation fo touch | Active comparator | Not described Receives: Behavioral: sensory relearning |
| Observation of pictures | Active comparator | Not described Receives: Behavioral: sensory relearning |
| Imagery of touch | Active comparator | Not described Receives: Behavioral: sensory relearning |
| Mirror therapy | Active comparator | Not described Receives: Behavioral: sensory relearning |
What is being measured
The primary outcome is the main question the study is designed to answer.
PETS - The Problematic Experience of Therapy Scale
questionnaire, 5-grading scale from "strongly agree" to 'strongly disagree'' to all items in a subscale are recoded as ''no barriers'', and all other scores are recoded as ''some barriers or doubts'' for completing the therapy/sensory relearning.
Measured: 4 weeks post intervention
ESRQ - Early sensory relearing questionaire
questionnaire, 5-grading scale from "strongly agree" to 'strongly disagree''
Measured: 4 weeks post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
- Study start1 Jun 2022
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Nerve InjuryStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lund University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ulrika Wijk, Lund University Hospital
- Investigators
- Lars Dahlin, Prof, Study chair, Lund University/Region Skane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05611983
- Sponsor's protocol ID
- Dnr 2021-03519
- Status last verified
- Mar 2024
- First submitted
- 3 Nov 2022
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vikstrom P, Carlsson I, Rosen B, Bjorkman A. Patients' views on early sensory relearning following nerve repair-a Q-methodology study. J Hand Ther. 2018 Oct-Dec;31(4):443-450. doi: 10.1016/j.jht.2017.07.003. Epub 2017 Sep 28.
PubMed 28967458Rosen B, Vikstrom P, Turner S, McGrouther DA, Selles RW, Schreuders TA, Bjorkman A. Enhanced early sensory outcome after nerve repair as a result of immediate post-operative re-learning: a randomized controlled trial. J Hand Surg Eur Vol. 2015 Jul;40(6):598-606. doi: 10.1177/1753193414553163. Epub 2014 Oct 7.
PubMed 25294735Bassolino M, Campanella M, Bove M, Pozzo T, Fadiga L. Training the motor cortex by observing the actions of others during immobilization. Cereb Cortex. 2014 Dec;24(12):3268-76. doi: 10.1093/cercor/bht190. Epub 2013 Jul 29.
PubMed 23897648Duffau H. Brain plasticity: from pathophysiological mechanisms to therapeutic applications. J Clin Neurosci. 2006 Nov;13(9):885-97. doi: 10.1016/j.jocn.2005.11.045. Epub 2006 Oct 17.
PubMed 17049865Vikstrom P, Rosen B, Carlsson IK, Bjorkman A. The effect of early relearning on sensory recovery 4 to 9 years after nerve repair: a report of a randomized controlled study. J Hand Surg Eur Vol. 2018 Jul;43(6):626-630. doi: 10.1177/1753193418767024. Epub 2018 Apr 16.
PubMed 29661095
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experience and Feasibility of Methods for Early Sensory Training Phase 1 - From a User Perspective
- ClinicalTrials.gov ID
- NCT05611983
- Acronym / sponsor ID
- Dnr 2021-03519
- Conditions
- Nerve Injury, Peripheral Nerve Injuries
- Keywords
- periferal nerve injuries, sensory relearning, rehabilitation, imagery, mirror therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Lund University HospitalUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 10 Nov 2022 (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.
The good effects of using guided plasticity for a rehabilitative purpose in case of nerve damage have been shown, but a problem that has been presented is that some individuals find it difficult to assimilate these effects due to difficulties in carrying out abstract training or due to a lack of motivation. In early sensory training, the plasticity of the brain is used. Methods for early sensory training that have been described are: 1) mental imagery of touch (mental imagery), 2) observation of touch, 3) mirror training, 4) use of images for visualization of touch. The method needs to be developed and refined to be able to offer individual training plans in order to find a motivating and meaningful form of training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Observation fo touch | Active comparator | Behavioral: sensory relearning |
| Observation of pictures | Active comparator | Behavioral: sensory relearning |
| Imagery of touch | Active comparator | Behavioral: sensory relearning |
| Mirror therapy | Active comparator | Behavioral: sensory relearning |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- >= 50% injury of N. Medianus/ N. Ulnaris or 100% digital nerve injury dig I and/or dig II
- Ålder: ≥ 18 år
Key exclusion criteria (3 listed)
- Impaired cognitive ability
- Documented psychiatric diagnosis
- Inability to master the Swedish language
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 |
|---|---|---|
| sensory relearningfeasibility of early sensory relearning | Behavioural | Imagery of touch, Mirror therapy, Observation fo touch, Observation of pictures |
Primary outcome
PETS - The Problematic Experience of Therapy Scale
Time frame: 4 weeks post intervention
questionnaire, 5-grading scale from "strongly agree" to 'strongly disagree'' to all items in a subscale are recoded as ''no barriers'', and all other scores are recoded as ''some barriers or doubts'' for completing the therapy/sensory relearning.
ESRQ - Early sensory relearing questionaire
Time frame: 4 weeks post intervention
questionnaire, 5-grading scale from "strongly agree" to 'strongly disagree''
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Background: PubMed 28967458Vikstrom P, Carlsson I, Rosen B, Bjorkman A. Patients' views on early sensory relearning following nerve repair-a Q-methodology study. J Hand Ther. 2018 Oct-Dec;31(4):443-450. doi: 10.1016/j.jht.2017.07.003. Epub 2017 Sep 28.
- Background: PubMed 25294735Rosen B, Vikstrom P, Turner S, McGrouther DA, Selles RW, Schreuders TA, Bjorkman A. Enhanced early sensory outcome after nerve repair as a result of immediate post-operative re-learning: a randomized controlled trial. J Hand Surg Eur Vol. 2015 Jul;40(6):598-606. doi: 10.1177/1753193414553163. Epub 2014 Oct 7.
- Background: PubMed 23897648Bassolino M, Campanella M, Bove M, Pozzo T, Fadiga L. Training the motor cortex by observing the actions of others during immobilization. Cereb Cortex. 2014 Dec;24(12):3268-76. doi: 10.1093/cercor/bht190. Epub 2013 Jul 29.
- Background: PubMed 17049865Duffau H. Brain plasticity: from pathophysiological mechanisms to therapeutic applications. J Clin Neurosci. 2006 Nov;13(9):885-97. doi: 10.1016/j.jocn.2005.11.045. Epub 2006 Oct 17.
- Results publication: PubMed 29661095Vikstrom P, Rosen B, Carlsson IK, Bjorkman A. The effect of early relearning on sensory recovery 4 to 9 years after nerve repair: a report of a randomized controlled study. J Hand Surg Eur Vol. 2018 Jul;43(6):626-630. doi: 10.1177/1753193418767024. Epub 2018 Apr 16.
- Individual participant dataSharing planned: No
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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.
Lars Dahlin, Prof study chair
Lund University/Region Skane
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sensory relearning in people with Nerve Injury and Peripheral Nerve Injuries, run by Lund University Hospital 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 3 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 15 Mar 2024. 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?
Contact Ulrika Wijk, PhD (+4640331744, ulrika.wijk@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PETS - The Problematic Experience of Therapy Scale (time frame: 4 weeks post intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05611983, which also lists 5 linked publications.
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 15 Mar 2024.