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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.

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

Clinicaltrials.gov identifier NCT03937492

Recruitment Status Not yet recruiting

First Posted May 3, 2019

Last update posted May 3, 2019

Study Description

Brief summary:

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

  • Condition or Disease:Surgery
    Wrist Fracture
    CRPS (Complex Regional Pain Syndromes)
    Distal Radius Fracture
  • Intervention/Treatment: Other: GMI protocol
    Other: Standard Rehabilitation Protocol
  • Phase: N/A
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 Design
  • Study Type: Interventional
  • 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 2019
  • Estimated Primary Completion Date: May 2020
  • Estimated Study Completion Date: December 2020
Arms and interventions
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: left/right descrimination visual motor imagery 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.
Outcome Measures
  • 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
Eligibility Criteria
  • Ages Eligible for Study: 18 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

Contacts and Locations
Contacts

Contact: Susanna Pagella 00393283092462 pagella87@gmail.com

Contact: Alessandra Viola 00393482437807 alessandra.viola92@gmail.com

Locations
Sponsors and Collaborators

Ergoterapia Manoegomito Sagl

Investigators

Principal Investigator: Susanna Pagella Ergoterapia Manoegomito Sagl

More Information
  • Responsible Party: 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)
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Ergoterapia Manoegomito Sagl: GMI
    CRPS
    Distal radius fracture
  • Additional relevant MeSH terms: Complex Regional Pain Syndromes
    Reflex Sympathetic Dystrophy
    Fractures, Bone
    Radius Fractures