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
About this trial
This is an interventional treatment trial for Wrist Fracture focused on measuring GMI, CRPS, Distal radius fracture
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
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
NCT ID
NCT03937492
First Posted
April 30, 2019
Last Updated
May 2, 2019
Sponsor
Ergoterapia Manoegomito Sagl
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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