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Effects of Action Observation Therapy and Motor Imagery Administered During Immobilization Period After Surgical Fixation of Distal Radius

Primary Purpose

Distal Radius Fracture

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Motor Imagery and Action Observation Training
Sponsored by
Istituto Clinico Humanitas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Distal Radius Fracture

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Right handed subjects Subjects after surgical distal radius fracture fixation Exclusion Criteria: Concomitant fractures of upper limbs Pathological fractures Cognitive or psychiatric disorders Neurological or reumatici diseases

Sites / Locations

  • Istituto Clinico HumanitasRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

MI+AOT

Control

Arm Description

Subjects assigned to this group will be asked to perform Motor Imagery and Action Observation Training during immobilisation period after surgery. The training will be performed once a day, for three weeks. The duration of the training will last about 15 minutes.

Subjects assigned will be asked to follow standard care pathway during immobilisation period.

Outcomes

Primary Outcome Measures

Change of Purdue Pegboard Test score
Change of Hand Dexterity test

Secondary Outcome Measures

Change of Grip test
Change in Grip strength evaluation with Jamar dynamometer
Change of Pinch test
Change of Pinch strength evaluation
Change of Range of motion
Change of Flexion, Extension, Ulnar deviation, Radial Deviation, Supination and Pronation measurement

Full Information

First Posted
April 18, 2023
Last Updated
May 16, 2023
Sponsor
Istituto Clinico Humanitas
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1. Study Identification

Unique Protocol Identification Number
NCT05867199
Brief Title
Effects of Action Observation Therapy and Motor Imagery Administered During Immobilization Period After Surgical Fixation of Distal Radius
Official Title
Effects of Action Observation Therapy and Motor Imagery Administered During Immobilization Period After Surgical Fixation of Distal Radius
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Clinico Humanitas

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 goal of this trial is to verify the effectiveness of Motor Imagery and Action Observation Training in subjects undergoing surgery for distal radius fracture fixation. The main question it aims to answer is: - can action observation and motor imagery training administered during immobilisation period improve functional outcome after distal radius fracture fixation? Participants will be asked to perform hand dexterity test and grip and pinch strength evaluation Subjects assigned to control group will follow standard care

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Radius Fracture

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MI+AOT
Arm Type
Experimental
Arm Description
Subjects assigned to this group will be asked to perform Motor Imagery and Action Observation Training during immobilisation period after surgery. The training will be performed once a day, for three weeks. The duration of the training will last about 15 minutes.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Subjects assigned will be asked to follow standard care pathway during immobilisation period.
Intervention Type
Behavioral
Intervention Name(s)
Motor Imagery and Action Observation Training
Intervention Description
The training consists of watching videos of actions performed with the hand. At the end of the video the subject is subsequently asked to imagine performing the action just seen
Primary Outcome Measure Information:
Title
Change of Purdue Pegboard Test score
Description
Change of Hand Dexterity test
Time Frame
After surgery (T0); 3 weeks after surgery (T1); 8 weeks after surgery (T2); 6 motnhs after surgery (T3)
Secondary Outcome Measure Information:
Title
Change of Grip test
Description
Change in Grip strength evaluation with Jamar dynamometer
Time Frame
After surgery (T0); 3 weeks after surgery (T1); 8 weeks after surgery (T2); 6 motnhs after surgery (T3)
Title
Change of Pinch test
Description
Change of Pinch strength evaluation
Time Frame
After surgery (T0); 3 weeks after surgery (T1); 8 weeks after surgery (T2); 6 motnhs after surgery (T3)
Title
Change of Range of motion
Description
Change of Flexion, Extension, Ulnar deviation, Radial Deviation, Supination and Pronation measurement
Time Frame
After surgery (T0); 3 weeks after surgery (T1); 8 weeks after surgery (T2); 6 motnhs after surgery (T3)
Other Pre-specified Outcome Measures:
Title
Change of Patient Rated Wrist Hand Evaluation
Description
Questionnaire about self reported rating of Hand and Wrist functionality
Time Frame
After surgery (T0); 3 weeks after surgery (T1); 8 weeks after surgery (T2); 6 motnhs after surgery (T3)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Right handed subjects Subjects after surgical distal radius fracture fixation Exclusion Criteria: Concomitant fractures of upper limbs Pathological fractures Cognitive or psychiatric disorders Neurological or reumatici diseases
Facility Information:
Facility Name
Istituto Clinico Humanitas
City
Rozzano
State/Province
Milan
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roberto Gatti, Prof
Phone
0282245610
Email
roberto.gatti@hunimed.eu
First Name & Middle Initial & Last Name & Degree
Roberto Gatti, Prof
First Name & Middle Initial & Last Name & Degree
Francesco Scandelli, Dr

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Effects of Action Observation Therapy and Motor Imagery Administered During Immobilization Period After Surgical Fixation of Distal Radius

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