Experience and Feasibility of Methods for Early Sensory Training
1 other identifier
interventional
60
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2022
CompletedFirst Submitted
Initial submission to the registry
November 3, 2022
CompletedFirst Posted
Study publicly available on registry
November 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2024
CompletedMarch 15, 2024
March 1, 2024
2 years
November 3, 2022
March 14, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
ESRQ - Early sensory relearing questionaire
questionnaire, 5-grading scale from "strongly agree" to 'strongly disagree''
4 weeks post intervention
Study Arms (4)
Observation fo touch
ACTIVE COMPARATORObservation of pictures
ACTIVE COMPARATORImagery of touch
ACTIVE COMPARATORMirror therapy
ACTIVE COMPARATORInterventions
feasibility of early sensory relearning
Eligibility Criteria
You may qualify if:
- \>= 50% injury of N. Medianus/ N. Ulnaris or 100% digital nerve injury dig I and/or dig II
- Ålder: ≥ 18 år
You may not qualify if:
- Impaired cognitive ability
- Documented psychiatric diagnosis
- Inability to master the Swedish language
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Skane university hospital
Malmo, Skåne County, 20502, Sweden
Related Publications (5)
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.
PMID: 28967458BACKGROUNDRosen 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.
PMID: 25294735BACKGROUNDBassolino 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.
PMID: 23897648BACKGROUNDDuffau 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.
PMID: 17049865BACKGROUNDVikstrom 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.
PMID: 29661095RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Lars Dahlin, Prof
Lund University/Region Skane
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- The outcome assessor/investigator are blinded from which intervention given.
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 3, 2022
First Posted
November 10, 2022
Study Start
June 1, 2022
Primary Completion
June 1, 2024
Study Completion
June 1, 2024
Last Updated
March 15, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share