Wrist FractureNCT03937492
EFFECTIVENESS OF GRADED MOTOR IMAGERY TO PREVENT CRPS IN PATIENTS WITH DISTAL RADIUS FRACTURE AFTER SURGERY
A study testing GMI protocol and Standard Rehabilitation Protocol in people with Wrist Fracture and CRPS (Complex Regional Pain Syndromes), run by Ergoterapia Manoegomito Sagl.
Trial summary
The study would like show that patients who follow a protocol with GMI are less probability to develop CRPS Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Wrist Fracture, CRPS (Complex Regional Pain Syndromes), Distal Radius Fracture
- What is being tested?
- GMI protocol and Standard Rehabilitation Protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 2 May 2019to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with distal radius fracture after surgery
- 18 to 75 years old
- Male and female
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: EFFECTIVENESS OF GRADED MOTOR IMAGERY TO PREVENT CRPS IN PATIENTS WITH DISTAL RADIUS FRACTURE AFTER SURGERY: A RANDOMIZED CONTROLLED TRIAL
The study would like show that patients who follow a protocol with GMI are less probability to develop CRPS
Read the 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.
- Being tested
- GMI protocol, Standard Rehabilitation Protocol
- Keywords
- GMI, CRPS, Distal radius fracture
- Medical subject headings
- Wrist Fractures, Complex Regional Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GMI protocolOther
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 ProtocolOther
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.
| Study group | Role | What they receive |
|---|---|---|
| A group | Experimental | In this group patients follow standard treatment after radius fracture plus GMI procol Receives: Other: GMI protocol; Other: Standard Rehabilitation Protocol |
| B group | Active comparator | In this group patients follow standard treatment after radius fracture Receives: Other: Standard Rehabilitation Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range Of Motion
Change in active and passive range of motion about hand and wrist
Measured: Baseline and 8 weeks
Secondary outcomes (3)
Patient-rated wrist/hand evaluation (prwhe)
Decrease in difficulty of doing activities of daily living and decrease pain
Measured: Baseline and 8 weeks
Jamar hand dynamometer
Improve strength
Measured: Baseline and 8 weeks
McGill pain questionnaire
Decrease pain
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2019
- Study start2 May 2019 (estimated)
- Primary completion2 May 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wrist FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ergoterapia Manoegomito Sagl
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pagella Susanna, Ergoterapia Manoegomito Sagl
- Investigators
- Susanna Pagella, Principal investigator, Ergoterapia Manoegomito Sagl
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03937492
- Sponsor's protocol ID
- Ergoterapia manoegomito
- Status last verified
- May 2019
- First submitted
- 30 Apr 2019
- Last updated
- 3 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECTIVENESS OF GRADED MOTOR IMAGERY TO PREVENT CRPS IN PATIENTS WITH DISTAL RADIUS FRACTURE AFTER SURGERY: A RANDOMIZED CONTROLLED TRIAL
- ClinicalTrials.gov ID
- NCT03937492
- Acronym / sponsor ID
- Ergoterapia manoegomito
- Keywords
- GMI, CRPS, Distal radius fracture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ergoterapia Manoegomito SaglUniversity, hospital or other
- Study start
- 2 May 2019 (estimated)
- Primary completion
- 2 May 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 3 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A group | Experimental | Other: GMI protocol, Other: Standard Rehabilitation ProtocolIn this group patients follow standard treatment after radius fracture plus GMI procol |
| B group | Active comparator | Other: Standard Rehabilitation ProtocolIn this group patients follow standard treatment after radius fracture |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with distal radius fracture after surgery
- 18 to 75 years old
- Male and female
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GMI protocolThis 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. | Other | A group |
| Standard Rehabilitation ProtocolThis 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. | Other | A group, B group |
Primary outcome
Range Of Motion
Time frame: Baseline and 8 weeks
Change in active and passive range of motion about hand and wrist
3 secondary outcomes
Patient-rated wrist/hand evaluation (prwhe)
Time frame: Baseline and 8 weeks
Jamar hand dynamometer
Time frame: Baseline and 8 weeks
McGill pain questionnaire
Time frame: Baseline and 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2019.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susanna Pagella principal investigator
Ergoterapia Manoegomito Sagl
Questions about this trial
What is this clinical trial studying?
A study testing GMI protocol and Standard Rehabilitation Protocol in people with Wrist Fracture and CRPS (Complex Regional Pain Syndromes), run by Ergoterapia Manoegomito Sagl.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Susanna Pagella (00393283092462, pagella87@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range Of Motion (time frame: Baseline and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2019.