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

NCT05867199 | Unknown

• 1 other identifier: CFL22/08
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Distal Radius Fracture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change of Grip test

  After surgery (T0); 3 weeks after surgery (T1); 8 weeks after surgery (T2); 6 motnhs after surgery (T3)

• Change of Pinch test

  After surgery (T0); 3 weeks after surgery (T1); 8 weeks after surgery (T2); 6 motnhs after surgery (T3)

• Change of Range of motion

  After surgery (T0); 3 weeks after surgery (T1); 8 weeks after surgery (T2); 6 motnhs after surgery (T3)

Other Outcomes (1)

• 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)

Study Arms (2)

MI+AOT

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

Motor Imagery and Action Observation Training BEHAVIORAL

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

MI+AOT

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Right handed subjects
• Subjects after surgical distal radius fracture fixation

You may not qualify if:

• Concomitant fractures of upper limbs
• Pathological fractures
• Cognitive or psychiatric disorders
• Neurological or reumatici diseases

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

Study Sites (1)

Istituto Clinico Humanitas

Rozzano, Milan, 20089, Italy

RECRUITING

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2023
• First Posted: May 19, 2023
• Study Start: April 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: March 31, 2024
• Last Updated: May 19, 2023

Record last verified: 2023-05

Locations

IT (1)