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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05867199
Other study ID # CFL22/08
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 1, 2023
Est. completion date March 31, 2024

Study information

Verified date May 2023
Source Istituto Clinico Humanitas
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date March 31, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Italy Istituto Clinico Humanitas Rozzano Milan

Sponsors (1)

Lead Sponsor Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Other 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)
Primary 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 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)
Secondary 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)
Secondary 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)
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