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

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

Study Overview

• Status: Recruiting
• Conditions: Distal Radius Fracture
• Intervention / Treatment: Behavioral: Motor Imagery and Action Observation Training

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Milan
    • Rozzano, Milan, Italy, 20089
      • Recruiting
      • Istituto Clinico Humanitas
      • Contact: Roberto Gatti, Prof; Phone Number: 0282245610; Email: roberto.gatti@hunimed.eu
      • Principal Investigator: Roberto Gatti, Prof
      • Sub-Investigator: Francesco Scandelli, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MI+AOT; 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.	Behavioral: Motor Imagery and Action Observation Training; 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
No Intervention: Control; Subjects assigned will be asked to follow standard care pathway during immobilisation period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Purdue Pegboard Test score	Change of Hand Dexterity test	After surgery (T0); 3 weeks after surgery (T1); 8 weeks after surgery (T2); 6 motnhs after surgery (T3)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Grip test	Change in Grip strength evaluation with Jamar dynamometer	After surgery (T0); 3 weeks after surgery (T1); 8 weeks after surgery (T2); 6 motnhs after surgery (T3)
Change of Pinch test	Change of Pinch strength evaluation	After surgery (T0); 3 weeks after surgery (T1); 8 weeks after surgery (T2); 6 motnhs after surgery (T3)
Change of Range of motion	Change of Flexion, Extension, Ulnar deviation, Radial Deviation, Supination and Pronation measurement	After surgery (T0); 3 weeks after surgery (T1); 8 weeks after surgery (T2); 6 motnhs after surgery (T3)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Patient Rated Wrist Hand Evaluation	Questionnaire about self reported rating of Hand and Wrist functionality	After surgery (T0); 3 weeks after surgery (T1); 8 weeks after surgery (T2); 6 motnhs after surgery (T3)

Collaborators and Investigators

• Sponsor: Istituto Clinico Humanitas

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): March 31, 2024

Study Registration Dates

• First Submitted: April 18, 2023
• First Submitted That Met QC Criteria: May 16, 2023
• First Posted (Actual): May 19, 2023

Study Record Updates

• Last Update Posted (Actual): May 19, 2023
• Last Update Submitted That Met QC Criteria: May 16, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Arm Injuries; Forearm Injuries; Wrist Injuries; Radius Fractures; Wrist Fractures
• Other Study ID Numbers: CFL22/08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No