Experience and Feasibility of Methods for Early Sensory Training

March 14, 2024 updated by: Ulrika Wijk, Lund University Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Sweden
    • Skane
      • Malmö, Skane, Sweden, 20502
        • Recruiting
        • Skane University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Observation fo touch
Behavioral: sensory relearning
feasibility of early sensory relearning
Active Comparator: Observation of pictures
Behavioral: sensory relearning
feasibility of early sensory relearning
Active Comparator: Imagery of touch
Behavioral: sensory relearning
feasibility of early sensory relearning
Active Comparator: Mirror therapy
Behavioral: sensory relearning
feasibility of early sensory relearning

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 weeks post intervention
ESRQ - Early sensory relearing questionaire
Time Frame: 4 weeks post intervention
questionnaire, 5-grading scale from "strongly agree" to 'strongly disagree''
4 weeks post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lund University Hospital

Investigators

  • Study Chair: Lars Dahlin, Prof, Lund University/Region Skåne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

November 3, 2022

First Submitted That Met QC Criteria

November 3, 2022

First Posted (Actual)

November 10, 2022

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 14, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dnr 2021-03519

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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