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

Primary Purpose

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

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
GMI protocol
Standard Rehabilitation Protocol
Sponsored by
Ergoterapia Manoegomito Sagl
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wrist Fracture focused on measuring GMI, CRPS, Distal radius fracture

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    A group

    B group

    Arm Description

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

    In this group patients follow standard treatment after radius fracture

    Outcomes

    Primary Outcome Measures

    Range Of Motion
    Change in active and passive range of motion about hand and wrist

    Secondary Outcome Measures

    Patient-rated wrist/hand evaluation (prwhe)
    Decrease in difficulty of doing activities of daily living and decrease pain
    Jamar hand dynamometer
    Improve strength
    McGill pain questionnaire
    Decrease pain

    Full Information

    First Posted
    April 30, 2019
    Last Updated
    May 2, 2019
    Sponsor
    Ergoterapia Manoegomito Sagl
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03937492
    Brief Title
    EFFECTIVENESS OF GRADED MOTOR IMAGERY TO PREVENT CRPS IN PATIENTS WITH DISTAL RADIUS FRACTURE AFTER SURGERY
    Official Title
    EFFECTIVENESS OF GRADED MOTOR IMAGERY TO PREVENT CRPS IN PATIENTS WITH DISTAL RADIUS FRACTURE AFTER SURGERY: A RANDOMIZED CONTROLLED TRIAL
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 2, 2019 (Anticipated)
    Primary Completion Date
    May 2, 2020 (Anticipated)
    Study Completion Date
    December 31, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ergoterapia Manoegomito Sagl

    4. Oversight

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

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Wrist Fracture, CRPS (Complex Regional Pain Syndromes), Distal Radius Fracture, Surgery
    Keywords
    GMI, CRPS, Distal radius fracture

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    A group
    Arm Type
    Experimental
    Arm Description
    In this group patients follow standard treatment after radius fracture plus GMI procol
    Arm Title
    B group
    Arm Type
    Active Comparator
    Arm Description
    In this group patients follow standard treatment after radius fracture
    Intervention Type
    Other
    Intervention Name(s)
    GMI protocol
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Standard Rehabilitation Protocol
    Intervention Description
    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 Measure Information:
    Title
    Range Of Motion
    Description
    Change in active and passive range of motion about hand and wrist
    Time Frame
    Baseline and 8 weeks
    Secondary Outcome Measure Information:
    Title
    Patient-rated wrist/hand evaluation (prwhe)
    Description
    Decrease in difficulty of doing activities of daily living and decrease pain
    Time Frame
    Baseline and 8 weeks
    Title
    Jamar hand dynamometer
    Description
    Improve strength
    Time Frame
    Baseline and 8 weeks
    Title
    McGill pain questionnaire
    Description
    Decrease pain
    Time Frame
    Baseline and 8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Susanna Pagella
    Phone
    00393283092462
    Email
    pagella87@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Alessandra Viola
    Phone
    00393482437807
    Email
    alessandra.viola92@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Susanna Pagella
    Organizational Affiliation
    Ergoterapia Manoegomito Sagl
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

    Learn more about this trial

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

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