EFFECTIVENESS OF GRADED MOTOR IMAGERY TO PREVENT CRPS IN PATIENTS WITH DISTAL RADIUS FRACTURE AFTER SURGERY
1 other identifier
interventional
60
0 countries
N/A
Brief Summary
The study would like show that patients who follow a protocol with GMI are less probability to develop CRPS
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2019
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 30, 2019
CompletedStudy Start
First participant enrolled
May 2, 2019
CompletedFirst Posted
Study publicly available on registry
May 3, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 2, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedMay 3, 2019
May 1, 2019
1 year
April 30, 2019
May 2, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Range Of Motion
Change in active and passive range of motion about hand and wrist
Baseline and 8 weeks
Secondary Outcomes (3)
Patient-rated wrist/hand evaluation (prwhe)
Baseline and 8 weeks
Jamar hand dynamometer
Baseline and 8 weeks
McGill pain questionnaire
Baseline and 8 weeks
Study Arms (2)
A group
EXPERIMENTALIn this group patients follow standard treatment after radius fracture plus GMI procol
B group
ACTIVE COMPARATORIn this group patients follow standard treatment after radius fracture
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Patients with distal radius fracture after surgery
- to 75 years old
- Male and female
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Susanna Pagella
Ergoterapia Manoegomito Sagl
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 30, 2019
First Posted
May 3, 2019
Study Start
May 2, 2019
Primary Completion
May 2, 2020
Study Completion
December 31, 2020
Last Updated
May 3, 2019
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR