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Effects of Motor Imagery on Trapeziometacarpal Osteoarthritis in Women During the Postoperative Immobilization Period

Primary Purpose

Osteoarthritis Thumb, Immobilization

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
motor imagery
Sponsored by
Eva Prado Robles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis Thumb focused on measuring Mental practice, motor imagery, trapeziometacarpal osteoarthritis

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • The participants on the surgical waiting list of the Hospital of León

Exclusion Criteria:

  • Other hand pathologies

Sites / Locations

  • EvaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

control group

intervention group

Arm Description

Non intervention group

motor imagery group

Outcomes

Primary Outcome Measures

Change from Preoperative pain to postoperative pain
Visual Analogue Scale (VAS). "0" (better) to "10" (worse)

Secondary Outcome Measures

Mobility of hand
Kapandji test
Joint mobility
Goniometer
Strength
Baseline Pinch Gauge, Hydraulic.
Edema/inflammation
Measuring tape. Centimeter measurement. Wrist and thumb perimeter
Quality of life and function
The Disabilities of the Arm, Shoulder and Hand questionnaire (DASH). 30-item disability/symptom scale, scored 0 (no disability) to 100
Manual function
The Cochin Hand Functional Scale (CHFS) questionnaire. "0" better to "90" worse

Full Information

First Posted
January 16, 2019
Last Updated
February 5, 2022
Sponsor
Eva Prado Robles
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1. Study Identification

Unique Protocol Identification Number
NCT03815734
Brief Title
Effects of Motor Imagery on Trapeziometacarpal Osteoarthritis in Women During the Postoperative Immobilization Period
Official Title
Effects of Motor Imagery on Trapeziometacarpal Osteoarthritis in Women During the Postoperative Immobilization Period
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
September 1, 2022 (Anticipated)
Study Completion Date
September 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Eva Prado Robles

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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis Thumb, Immobilization
Keywords
Mental practice, motor imagery, trapeziometacarpal osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
No Intervention
Arm Description
Non intervention group
Arm Title
intervention group
Arm Type
Experimental
Arm Description
motor imagery group
Intervention Type
Procedure
Intervention Name(s)
motor imagery
Intervention Description
motor imagery during the postoperative immobilization period
Primary Outcome Measure Information:
Title
Change from Preoperative pain to postoperative pain
Description
Visual Analogue Scale (VAS). "0" (better) to "10" (worse)
Time Frame
2 weeks before the surgery/5, 7 and 11 weeks after surgery
Secondary Outcome Measure Information:
Title
Mobility of hand
Description
Kapandji test
Time Frame
2 weeks before the surgery/5, 7 and 11 weeks after surgery
Title
Joint mobility
Description
Goniometer
Time Frame
2 weeks before the surgery/5, 7 and 11 weeks after surgery
Title
Strength
Description
Baseline Pinch Gauge, Hydraulic.
Time Frame
2 weeks before the surgery/5, 7 and 11 weeks after surgery
Title
Edema/inflammation
Description
Measuring tape. Centimeter measurement. Wrist and thumb perimeter
Time Frame
2 weeks before the surgery/5, 7 and 11 weeks after surgery
Title
Quality of life and function
Description
The Disabilities of the Arm, Shoulder and Hand questionnaire (DASH). 30-item disability/symptom scale, scored 0 (no disability) to 100
Time Frame
2 weeks before the surgery/5, 7 and 11 weeks after surgery
Title
Manual function
Description
The Cochin Hand Functional Scale (CHFS) questionnaire. "0" better to "90" worse
Time Frame
2 weeks before the surgery/5, 7 and 11 weeks after surgery

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The participants on the surgical waiting list of the Hospital of León Exclusion Criteria: Other hand pathologies
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eva Prado Robles
Phone
+34 696903684
Email
eprado@saludcastillayleon.es
First Name & Middle Initial & Last Name or Official Title & Degree
Jose Angel D Gil
Phone
+34 649645821
Email
eprado@saludcastillayleon.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jesús Seco Calvo
Organizational Affiliation
Universidad de León
Official's Role
Study Director
Facility Information:
Facility Name
Eva
City
León
ZIP/Postal Code
24196
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eva Prado Robles
Phone
696903684
Email
eprado@saludcastillayleon.es
First Name & Middle Initial & Last Name & Degree
Jose Angel Delgado Gil
Phone
649645821
Email
eprado@saludcastillayleon.es

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19345768
Citation
Stenekes MW, Geertzen JH, Nicolai JP, De Jong BM, Mulder T. Effects of motor imagery on hand function during immobilization after flexor tendon repair. Arch Phys Med Rehabil. 2009 Apr;90(4):553-9. doi: 10.1016/j.apmr.2008.10.029.
Results Reference
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Effects of Motor Imagery on Trapeziometacarpal Osteoarthritis in Women During the Postoperative Immobilization Period

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