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Effects of Proprioceptive Stimulation Under Visual Feedback in Patient With CRPS

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ClinicalTrials.gov Identifier: NCT02395211
Recruitment Status : Unknown
Verified February 2017 by University Hospital of Ferrara.
Recruitment status was:  Recruiting
First Posted : March 23, 2015
Last Update Posted : February 3, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital of Ferrara

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Complex Regional Pain Syndromes Behavioral: Usual Physiotherapy Device: Gloreha device Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Proprioceptive Stimulation Under Visual Feedback in Patient With CRPS: An Exploratory Study
Study Start Date : January 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Usual Physiotherapy Behavioral: 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 Device: Gloreha device
Proprioceptive stimulation under visual feedback are provided by the Gloreha device. The intervention will last 30 minute a day x 4 weeks




Primary Outcome Measures :
  1. Visual Analogue Scale [ Time Frame: Change measures (weeks: 0,4,16, 28) ]

Secondary Outcome Measures :
  1. Neuropathic Pain Symptom Inventory [ Time Frame: Change measures (weeks: 0,4,16, 28) ]
  2. 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.

  3. Erasmus MC modification to the (revised) Nottingham Sensory Assessment - Italian version [ Time Frame: Change measures (weeks: 0,4,16, 28) ]
  4. 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

  5. Pressure Pain Threshold [ Time Frame: Change measures (weeks: 0,4,16, 28) ]


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02395211


Contacts
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Contact: Sofia Straudi, MD + 390532238830 sofia.straudi@gmail.com
Contact: Marco Da Roit, PT +39 0532238720 m.daroit@ospfe.it

Locations
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Italy
Ferrara University Hospital Recruiting
Ferrara, Italy, 44121
Contact: Sofia Straudi, MD    0532238720    s.straudi@ospfe.it   
Principal Investigator: Sofia Straudi, MD         
Sub-Investigator: Marco Da Roit, PT         
Sub-Investigator: Claudia Pavarelli, PT         
Sub-Investigator: Fabio Manfredini, MD         
Sub-Investigator: Nicola Lamberti         
Sponsors and Collaborators
University Hospital of Ferrara
Investigators
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Principal Investigator: Sofia Straudi, MD Ferrara Rehabilitation Hospital

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Responsible Party: University Hospital of Ferrara
ClinicalTrials.gov Identifier: NCT02395211     History of Changes
Other Study ID Numbers: Studio_CRPS_gloreha
First Posted: March 23, 2015    Key Record Dates
Last Update Posted: February 3, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
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Complex Regional Pain Syndromes
Reflex Sympathetic Dystrophy
Autonomic Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases