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

Sponsor

Istituto Clinico Humanitas (Other)

Overall Status

Recruiting

CT.gov ID

NCT05867199

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Distal Radius Fracture	Behavioral: Motor Imagery and Action Observation Training	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Care Provider, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Mar 31, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Change of Purdue Pegboard Test score [After surgery (T0); 3 weeks after surgery (T1); 8 weeks after surgery (T2); 6 motnhs after surgery (T3)]
Change of Hand Dexterity test

Secondary Outcome Measures

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

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Istituto Clinico Humanitas	Rozzano	Milan	Italy	20089

Sponsors and Collaborators

Istituto Clinico Humanitas

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Istituto Clinico Humanitas

ClinicalTrials.gov Identifier:

NCT05867199

Other Study ID Numbers:

CFL22/08

First Posted:

May 19, 2023

Last Update Posted:

May 19, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Radius Fractures

Wrist Fractures

Study Results

No Results Posted as of May 19, 2023