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

NCT ID: NCT03937492

Last Updated: 2019-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-02

Study Completion Date

2020-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Wrist Fracture CRPS (Complex Regional Pain Syndromes) Distal Radius Fracture Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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A group

In this group patients follow standard treatment after radius fracture plus GMI procol

Group Type EXPERIMENTAL

GMI protocol

Intervention Type OTHER

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.

Standard Rehabilitation Protocol

Intervention Type OTHER

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.

B group

In this group patients follow standard treatment after radius fracture

Group Type ACTIVE_COMPARATOR

Standard Rehabilitation Protocol

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ergoterapia Manoegomito Sagl

OTHER

Sponsor Role lead

Responsible Party

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Pagella Susanna

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Susanna Pagella

Role: PRINCIPAL_INVESTIGATOR

Ergoterapia Manoegomito Sagl

Central Contacts

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Susanna Pagella

Role: CONTACT

00393283092462

Alessandra Viola

Role: CONTACT

00393482437807

Other Identifiers

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Ergoterapia manoegomito

Identifier Type: -

Identifier Source: org_study_id

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