Effects of Proprioceptive Stimulation Under Visual Feedback in Patient With CRPS

February 2, 2017 updated by: University Hospital of Ferrara

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

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.

Study Overview

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

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Ferrara, Italy, 44121
        • Recruiting
        • Ferrara University Hospital
        • Contact:
        • Principal Investigator:
          • Sofia Straudi, MD
        • Sub-Investigator:
          • Claudia Pavarelli, PT
        • Sub-Investigator:
          • Nicola Lamberti

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (ANTICIPATED)

December 1, 2017

Study Completion (ANTICIPATED)

June 1, 2018

Study Registration Dates

First Submitted

March 16, 2015

First Submitted That Met QC Criteria

March 19, 2015

First Posted (ESTIMATE)

March 23, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

February 3, 2017

Last Update Submitted That Met QC Criteria

February 2, 2017

Last Verified

February 1, 2017

More Information

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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