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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03937492
Other study ID # Ergoterapia manoegomito
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 2, 2019
Est. completion date December 31, 2020

Study information

Verified date May 2019
Source Ergoterapia Manoegomito Sagl
Contact Susanna Pagella
Phone 00393283092462
Email pagella87@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date December 31, 2020
Est. primary completion date May 2, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Intervention

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.
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ergoterapia Manoegomito Sagl

Outcome

Type Measure Description Time frame Safety issue
Primary Range Of Motion Change in active and passive range of motion about hand and wrist Baseline and 8 weeks
Secondary Patient-rated wrist/hand evaluation (prwhe) Decrease in difficulty of doing activities of daily living and decrease pain Baseline and 8 weeks
Secondary Jamar hand dynamometer Improve strength Baseline and 8 weeks
Secondary McGill pain questionnaire Decrease pain Baseline and 8 weeks
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