- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03815734
Effects of Motor Imagery on Trapeziometacarpal Osteoarthritis in Women During the Postoperative Immobilization Period
February 5, 2022 updated by: Eva Prado Robles
The aim of this study is to verify whether after trapeziometacarpal osteoarthrosis surgery and during the period of immobilization immediately after it, applying motor imagery, improvements are achieved on pain, strength, edema and / or inflammation, function and the joint range, accelerating the recovery process.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Motor imagery (IM) consists of a complex cognitive operation by which an action is simulated without doing it physically.
Many studies support the usefulness of motor imaging in rehabilitation after manual surgery.
An approach based on motor imagery may be useful in trapeziometacarpal osteoarthritis, and may be used to promote motor recovery after surgical treatment.
Study Type
Interventional
Enrollment (Anticipated)
40
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
- Name: Eva Prado Robles
- Phone Number: +34 696903684
- Email: eprado@saludcastillayleon.es
Study Contact Backup
- Name: Jose Angel D Gil
- Phone Number: +34 649645821
- Email: eprado@saludcastillayleon.es
Study Locations
-
-
-
León, Spain, 24196
- Recruiting
- Eva
-
Contact:
- Eva Prado Robles
- Phone Number: 696903684
- Email: eprado@saludcastillayleon.es
-
Contact:
- Jose Angel Delgado Gil
- Phone Number: 649645821
- Email: eprado@saludcastillayleon.es
-
-
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
50 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- The participants on the surgical waiting list of the Hospital of León
Exclusion Criteria:
- Other hand pathologies
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: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: control group
Non intervention group
|
|
Experimental: intervention group
motor imagery group
|
motor imagery during the postoperative immobilization period
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Preoperative pain to postoperative pain
Time Frame: 2 weeks before the surgery/5, 7 and 11 weeks after surgery
|
Visual Analogue Scale (VAS).
"0" (better) to "10" (worse)
|
2 weeks before the surgery/5, 7 and 11 weeks after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mobility of hand
Time Frame: 2 weeks before the surgery/5, 7 and 11 weeks after surgery
|
Kapandji test
|
2 weeks before the surgery/5, 7 and 11 weeks after surgery
|
Joint mobility
Time Frame: 2 weeks before the surgery/5, 7 and 11 weeks after surgery
|
Goniometer
|
2 weeks before the surgery/5, 7 and 11 weeks after surgery
|
Strength
Time Frame: 2 weeks before the surgery/5, 7 and 11 weeks after surgery
|
Baseline Pinch Gauge, Hydraulic.
|
2 weeks before the surgery/5, 7 and 11 weeks after surgery
|
Edema/inflammation
Time Frame: 2 weeks before the surgery/5, 7 and 11 weeks after surgery
|
Measuring tape.
Centimeter measurement.
Wrist and thumb perimeter
|
2 weeks before the surgery/5, 7 and 11 weeks after surgery
|
Quality of life and function
Time Frame: 2 weeks before the surgery/5, 7 and 11 weeks after surgery
|
The Disabilities of the Arm, Shoulder and Hand questionnaire (DASH).
30-item disability/symptom scale, scored 0 (no disability) to 100
|
2 weeks before the surgery/5, 7 and 11 weeks after surgery
|
Manual function
Time Frame: 2 weeks before the surgery/5, 7 and 11 weeks after surgery
|
The Cochin Hand Functional Scale (CHFS) questionnaire.
"0" better to "90" worse
|
2 weeks before the surgery/5, 7 and 11 weeks after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Jesús Seco Calvo, Universidad de León
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.
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)
January 1, 2019
Primary Completion (Anticipated)
September 1, 2022
Study Completion (Anticipated)
September 1, 2022
Study Registration Dates
First Submitted
January 16, 2019
First Submitted That Met QC Criteria
January 23, 2019
First Posted (Actual)
January 24, 2019
Study Record Updates
Last Update Posted (Actual)
February 8, 2022
Last Update Submitted That Met QC Criteria
February 5, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SALUDDOCTORADO
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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