- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02395211
Effects of Proprioceptive Stimulation Under Visual Feedback in Patient With CRPS
Effects of Proprioceptive Stimulation Under Visual Feedback in Patient With CRPS: An Exploratory Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The aim of this study is to evaluate feasibility of a a proprioceptive stimulation under visual feedback treatment protocol (using Gloreha® device) compared to usual physiotherapy treatment in sub-acute stroke patient with Complex regional pain syndrome.
Treatments effect will be evaluated on pain perception, upper extremity functionality and change in pain pressure treshold.
Usual physiotherapy consist of active or passive mobilization, extensor digiti and carpi functional electric stimulation, occupational therapy and taping.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sofia Straudi, MD
- Phone Number: + 390532238830
- Email: sofia.straudi@gmail.com
Study Contact Backup
- Name: Marco Da Roit, PT
- Phone Number: +39 0532238720
- Email: m.daroit@ospfe.it
Study Locations
-
-
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Ferrara, Italy, 44121
- Recruiting
- Ferrara University Hospital
-
Contact:
- Sofia Straudi, MD
- Phone Number: 0532238720
- Email: s.straudi@ospfe.it
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Principal Investigator:
- Sofia Straudi, MD
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Sub-Investigator:
- Claudia Pavarelli, PT
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Sub-Investigator:
- Nicola Lamberti
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- age > 18 years and < 85 years
- diagnosis of stroke < 6 months prior to study enrollment
- diagnosis of Complex regional pain syndrome according to Budapest Criteria
Exclusion Criteria:
- neurological or psychiatric pathology
- severe cardio-pulmonary, renal, hepatic diseases
- pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Usual Physiotherapy
|
Usual physiotherapy consist of active or passive mobilization, extensor digiti and carpi functional electric stimulation, occupational therapy and taping. The intervention will last 30 minute a day x 4 weeks |
EXPERIMENTAL: Gloreha device
|
Proprioceptive stimulation under visual feedback are provided by the Gloreha device.
The intervention will last 30 minute a day x 4 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Visual Analogue Scale
Time Frame: Change measures (weeks: 0,4,16, 28)
|
Change measures (weeks: 0,4,16, 28)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neuropathic Pain Symptom Inventory
Time Frame: Change measures (weeks: 0,4,16, 28)
|
Change measures (weeks: 0,4,16, 28)
|
|
McGill Pain Questionnaire
Time Frame: Change measures (weeks: 0,4,16, 28)
|
The MPQ is a self-report measure of pain studied with a number of diagnoses.
The MPQ assesses both the quality and intensity of subjective pain.
The MPQ is composed of 78 words, of which respondents choose those that best describe their experience of pain.
|
Change measures (weeks: 0,4,16, 28)
|
Erasmus MC modification to the (revised) Nottingham Sensory Assessment - Italian version
Time Frame: Change measures (weeks: 0,4,16, 28)
|
Change measures (weeks: 0,4,16, 28)
|
|
Fugl-Meyer Upper Extremity
Time Frame: Change measures (weeks: 0,4,16, 28)
|
Measure of upper extremity motor impairment.
The upper extremity score ranges from 0-66
|
Change measures (weeks: 0,4,16, 28)
|
Pressure Pain Threshold
Time Frame: Change measures (weeks: 0,4,16, 28)
|
Change measures (weeks: 0,4,16, 28)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Studio_CRPS_gloreha
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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