Back to resultsExperience and Feasibility of Methods for Early Sensory Training
Primary Purpose
Nerve Injury, Peripheral Nerve Injuries
Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
sensory relearning
Sponsored by
About this trial
This is an interventional treatment trial for Nerve Injury focused on measuring periferal nerve injuries, sensory relearning, rehabilitation, imagery, mirror therapy
Eligibility Criteria
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
Sites / Locations
- Skane university hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Observation fo touch
Observation of pictures
Imagery of touch
Mirror therapy
Arm Description
Outcomes
Primary Outcome Measures
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.
ESRQ - Early sensory relearing questionaire
questionnaire, 5-grading scale from "strongly agree" to 'strongly disagree''
Secondary Outcome Measures
Full Information
NCT ID
NCT05611983
First Posted
November 3, 2022
Last Updated
March 7, 2023
Sponsor
Lund University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05611983
Brief Title
Experience and Feasibility of Methods for Early Sensory Training
Official Title
Experience and Feasibility of Methods for Early Sensory Training Phase 1 - From a User Perspective
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lund University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nerve Injury, Peripheral Nerve Injuries
Keywords
periferal nerve injuries, sensory relearning, rehabilitation, imagery, mirror therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
The outcome assessor/investigator are blinded from which intervention given.
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Observation fo touch
Arm Type
Active Comparator
Arm Title
Observation of pictures
Arm Type
Active Comparator
Arm Title
Imagery of touch
Arm Type
Active Comparator
Arm Title
Mirror therapy
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
sensory relearning
Intervention Description
feasibility of early sensory relearning
Primary Outcome Measure Information:
Title
PETS - The Problematic Experience of Therapy Scale
Description
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.
Time Frame
4 weeks post intervention
Title
ESRQ - Early sensory relearing questionaire
Description
questionnaire, 5-grading scale from "strongly agree" to 'strongly disagree''
Time Frame
4 weeks post intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ulrika Wijk, PhD
Phone
+4640331744
Email
ulrika.wijk@med.lu.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars Dahlin, Prof
Organizational Affiliation
Lund University/Region Skane
Official's Role
Study Chair
Facility Information:
Facility Name
Skane university hospital
City
Malmö
State/Province
Skane
ZIP/Postal Code
20502
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ulrika Wijk
Phone
+4640331744
Email
ulrika.wijk@med.lu.se
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28967458
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.
Results Reference
background
PubMed Identifier
25294735
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.
Results Reference
background
PubMed Identifier
23897648
Citation
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.
Results Reference
background
PubMed Identifier
17049865
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.
Results Reference
background
PubMed Identifier
29661095
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 2018 Apr 16.
Results Reference
result
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Experience and Feasibility of Methods for Early Sensory Training
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