Nerve Injury Clinical Trial
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.
| Status | Recruiting |
| Enrollment | 60 |
| Est. completion date | June 1, 2024 |
| Est. primary completion date | June 1, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - >= 50% injury of N. Medianus/ N. Ulnaris or 100% digital nerve injury dig I and/or dig II - Ålder: = 18 år Exclusion Criteria: - Impaired cognitive ability - Documented psychiatric diagnosis - Inability to master the Swedish language |
| Country | Name | City | State |
|---|---|---|---|
| Sweden | Skane university hospital | Malmö | Skane |
| Lead Sponsor | Collaborator |
|---|---|
| Lund University Hospital |
Sweden,
Bassolino 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. — View Citation
Duffau 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. — View Citation
Rosen 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. — View Citation
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. — View Citation
Vikstrom 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 2 — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | 4 weeks post intervention | |
| Primary | ESRQ - Early sensory relearing questionaire | questionnaire, 5-grading scale from "strongly agree" to 'strongly disagree'' | 4 weeks post intervention |
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