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Trial record 23 of 27 for:    Recruiting, Not yet recruiting, Available Studies | "Reflex Sympathetic Dystrophy"

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

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ClinicalTrials.gov Identifier: NCT03937492
Recruitment Status : Not yet recruiting
First Posted : May 3, 2019
Last Update Posted : May 3, 2019
Sponsor:
Information provided by (Responsible Party):
Pagella Susanna, Ergoterapia Manoegomito Sagl

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

Condition or disease Intervention/treatment Phase
Wrist Fracture CRPS (Complex Regional Pain Syndromes) Distal Radius Fracture Surgery Other: GMI protocol Other: Standard Rehabilitation Protocol Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: EFFECTIVENESS OF GRADED MOTOR IMAGERY TO PREVENT CRPS IN PATIENTS WITH DISTAL RADIUS FRACTURE AFTER SURGERY: A RANDOMIZED CONTROLLED TRIAL
Estimated Study Start Date : May 2, 2019
Estimated Primary Completion Date : May 2, 2020
Estimated Study Completion Date : December 31, 2020


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.





Primary Outcome Measures :
  1. Range Of Motion [ Time Frame: Baseline and 8 weeks ]
    Change in active and passive range of motion about hand and wrist


Secondary Outcome Measures :
  1. Patient-rated wrist/hand evaluation (prwhe) [ Time Frame: Baseline and 8 weeks ]
    Decrease in difficulty of doing activities of daily living and decrease pain

  2. Jamar hand dynamometer [ Time Frame: Baseline and 8 weeks ]
    Improve strength

  3. McGill pain questionnaire [ Time Frame: Baseline and 8 weeks ]
    Decrease pain



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03937492


Contacts
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Contact: Susanna Pagella 00393283092462 pagella87@gmail.com
Contact: Alessandra Viola 00393482437807 alessandra.viola92@gmail.com

Sponsors and Collaborators
Ergoterapia Manoegomito Sagl
Investigators
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Principal Investigator: Susanna Pagella Ergoterapia Manoegomito Sagl

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Responsible Party: Pagella Susanna, Principal Investigator, Ergoterapia Manoegomito Sagl
ClinicalTrials.gov Identifier: NCT03937492     History of Changes
Other Study ID Numbers: Ergoterapia manoegomito
First Posted: May 3, 2019    Key Record Dates
Last Update Posted: May 3, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pagella Susanna, Ergoterapia Manoegomito Sagl:
GMI
CRPS
Distal radius fracture

Additional relevant MeSH terms:
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Complex Regional Pain Syndromes
Reflex Sympathetic Dystrophy
Fractures, Bone
Radius Fractures
Wounds and Injuries
Forearm Injuries
Arm Injuries
Autonomic Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases