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

Overview

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

Full Title of Study: “EFFECTIVENESS OF GRADED MOTOR IMAGERY TO PREVENT CRPS IN PATIENTS WITH DISTAL RADIUS FRACTURE AFTER SURGERY: A RANDOMIZED CONTROLLED TRIAL”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Investigator)
  • Study Primary Completion Date: May 2, 2020

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: A group
    • In this group patients follow standard treatment after radius fracture plus GMI procol
  • Active Comparator: B group
    • In this group patients follow standard treatment after radius fracture

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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
  • Gender Eligibility: All

    Minimum Age: 18 Years

    Maximum Age: 75 Years

    Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

    Investigator Details

    • Lead Sponsor
      • Ergoterapia Manoegomito Sagl
    • Provider of Information About this Clinical Study
      • Principal Investigator: Pagella Susanna, Principal Investigator – Ergoterapia Manoegomito Sagl
    • Overall Official(s)
      • Susanna Pagella, Principal Investigator, Ergoterapia Manoegomito Sagl
    • Overall Contact(s)
      • Susanna Pagella, 00393283092462, pagella87@gmail.com

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