EFFECTIVENESS OF GRADED MOTOR IMAGERY TO PREVENT CRPS IN PATIENTS WITH DISTAL RADIUS FRACTURE AFTER SURGERY

May 2, 2019 updated by: Pagella Susanna, Ergoterapia Manoegomito Sagl

EFFECTIVENESS OF GRADED MOTOR IMAGERY TO PREVENT CRPS IN PATIENTS WITH DISTAL RADIUS FRACTURE AFTER SURGERY: A RANDOMIZED CONTROLLED TRIAL

The study would like show that patients who follow a protocol with GMI are less probability to develop CRPS

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Distal radius fractures (DRF) has a high frequency in adults. Studies show that the upper limb is frequently affected by CRPS, especially if is preceded by a fracture.

Recent studies suggest that changes in cortical structures can contribute to the onset of CRPS.

GMI is a approved and efficacy method in CRPS rehabilitation, because it trains modified cortical areas throught 3 stadies: left-right discrimination, visual motor imagery and mirror therapy.

Literature shows that there are any studies about GMI efficacy on prevention CRPS in DRF after surgery.

This study would like to demostrate that, appling GMI in the early stages of rehabilitation plus standard rehabilitation protocol of DRF after surgery, CRPS cases are reducted.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with distal radius fracture after surgery
  • 18 to 75 years old
  • Male and female

Exclusion Criteria:

  • uncompliants patients
  • patients with neurological disorders or cognitive impairment
  • patients with TFCC injury or both ulna and radius fractures
  • patients with visually impairment
  • patients who don't speak or understand oral and written italian language

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A group
In this group patients follow standard treatment after radius fracture plus GMI procol
Other: GMI protocol

This group follow GMI program split in 3 step:

  1. left/right descrimination
  2. visual motor imagery
  3. mirror therapy

Patients perform this exercises 3 times every day and they have checks in therapy al least twice a week.

Other: Standard Rehabilitation Protocol

This group follow standard rehabilitation protocol, with active and passive motion of upper limb structure, including hand, wrist, elbow, shoulder.

Patients perform this exercises 3 times every day and they have checks in therapy al least twice a week.
Active Comparator: B group
In this group patients follow standard treatment after radius fracture
Other: Standard Rehabilitation Protocol

This group follow standard rehabilitation protocol, with active and passive motion of upper limb structure, including hand, wrist, elbow, shoulder.

Patients perform this exercises 3 times every day and they have checks in therapy al least twice a week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Range Of Motion
Time Frame: Baseline and 8 weeks
Change in active and passive range of motion about hand and wrist
Baseline and 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient-rated wrist/hand evaluation (prwhe)
Time Frame: Baseline and 8 weeks
Decrease in difficulty of doing activities of daily living and decrease pain
Baseline and 8 weeks
Jamar hand dynamometer
Time Frame: Baseline and 8 weeks
Improve strength
Baseline and 8 weeks
McGill pain questionnaire
Time Frame: Baseline and 8 weeks
Decrease pain
Baseline and 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ergoterapia Manoegomito Sagl

Investigators

  • Principal Investigator: Susanna Pagella, Ergoterapia Manoegomito Sagl

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 2, 2019

Primary Completion (Anticipated)

May 2, 2020

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

April 30, 2019

First Submitted That Met QC Criteria

May 2, 2019

First Posted (Actual)

May 3, 2019

Study Record Updates

Last Update Posted (Actual)

May 3, 2019

Last Update Submitted That Met QC Criteria

May 2, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ergoterapia manoegomito

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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