Effects of Proprioceptive Stimulation Under Visual Feedback in Patient With CRPS

Study Overview
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Brief Summary
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The aim of this study is to evaluate feasibility of 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.

Detailed Description
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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.

Official Title
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Effects of Proprioceptive Stimulation Under Visual Feedback in Patient With CRPS: An Exploratory Study

Conditions
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Complex Regional Pain Syndromes

Intervention / Treatment
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* Behavioral: Usual Physiotherapy
* Device: Gloreha device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual Physiotherapy<br> | Behavioral: Usual Physiotherapy<br>* 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<br>|
| Experimental: Gloreha device<br> | Device: Gloreha device<br>* Proprioceptive stimulation under visual feedback are provided by the Gloreha device. The intervention will last 30 minute a day x 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale |  | Change measures (weeks: 0,4,16, 28) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuropathic Pain Symptom Inventory |  | Change measures (weeks: 0,4,16, 28) | 
| McGill Pain Questionnaire | 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 |  | Change measures (weeks: 0,4,16, 28) | 
| Fugl-Meyer Upper Extremity | Measure of upper extremity motor impairment. The upper extremity score ranges from 0-66 | Change measures (weeks: 0,4,16, 28) | 
| Pressure Pain Threshold |  | Change measures (weeks: 0,4,16, 28) |