Effects of Proprioceptive Stimulation Under Visual Feedback in Patient With CRPS
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 16, 2015
CompletedFirst Posted
Study publicly available on registry
March 23, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedFebruary 3, 2017
February 1, 2017
2.9 years
March 16, 2015
February 2, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Visual Analogue Scale
Change measures (weeks: 0,4,16, 28)
Secondary Outcomes (5)
Neuropathic Pain Symptom Inventory
Change measures (weeks: 0,4,16, 28)
McGill Pain Questionnaire
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
Change measures (weeks: 0,4,16, 28)
Pressure Pain Threshold
Change measures (weeks: 0,4,16, 28)
Study Arms (2)
Usual Physiotherapy
ACTIVE COMPARATORGloreha device
EXPERIMENTALInterventions
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
Proprioceptive stimulation under visual feedback are provided by the Gloreha device. The intervention will last 30 minute a day x 4 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- neurological or psychiatric pathology
- severe cardio-pulmonary, renal, hepatic diseases
- pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ferrara University Hospital
Ferrara, Ferrara, 44121, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sofia Straudi, MD
Ferrara Rehabilitation Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 16, 2015
First Posted
March 23, 2015
Study Start
January 1, 2015
Primary Completion
December 1, 2017
Study Completion
June 1, 2018
Last Updated
February 3, 2017
Record last verified: 2017-02