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The investigators evaluate the effectiveness of the application of continuous passive motion device for hand rehabilitation in two classes of patients: with a residual active motion and without a residual active motion.
We will conduct a double blind clinical trial. A sample size calculation were performed to determine the necessary number of subjects needed for this study and was based upon the results of a previous pilot study. All patients had functional impairments of their upper extremities after the stroke.
We hypothesized that the hand-rehabilitation oriented with robotics assistance, would improve edema by paralysis of the upper limb even in patient without sensory pathway recovery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A-ROM Continuous Passive Rehabilitation | Experimental | The group of patients with Active Range Of Motion (A-ROM) is subjected to two session per day in the morning and in the afternoon over a period of two weeks (5 days per week). Each session is composed by 30 min of continuous passive motion rehabilitation and 60 min of physical and occupational therapy. |
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| P-ROM Continuous Passive Rehabilitation | Experimental | The group of patients with Passive Range Of Motion (P-ROM), i.e. without active movements of the hand at the baseline, is subjected to two session per day in the morning and in the afternoon over a period of two weeks (5 days per week). Each session is composed by 30 min of continuous passive motion rehabilitation and 60 min of physical and occupational therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A-ROM Continuous Passive Rehabilitation | Device | Half an hour of treatment during the morning with the "sequential" program (each finger is mobilized individually) and half an hour of treatment during the afternoon with the "synchronous" program (II-III-IV-V finger are mobilized simultaneously, the thumb individually). |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline of Perimeter edema | 1 day after the treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline of Visual analogue scale (VAS) | 1 day after the treatment | |
| Change from Baseline of Modified Ashworth Scale for Grading Spasticity (MAS) | 1 day after the treatment | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chiara Mulé, MD | Habilita, Ospedale di Sarnico | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Habilita, Ospedale di Sarnico | Sarnico | Bergamo | 24067 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21964036 | Background | Yamaguchi T, Tanabe S, Muraoka Y, Imai S, Masakado Y, Hase K, Kimura A, Liu M. Effects of integrated volitional control electrical stimulation (IVES) on upper extremity function in chronic stroke. Keio J Med. 2011;60(3):90-5. doi: 10.2302/kjm.60.90. | |
| 3809245 | Background | Bohannon RW, Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther. 1987 Feb;67(2):206-7. doi: 10.1093/ptj/67.2.206. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
|
| P-ROM Continuous Passive Rehabilitation | Device | Half an hour of treatment during the morning with the "sequential" program (each finger is mobilized individually) and half an hour of treatment during the afternoon with the "synchronous" program (II-III-IV-V finger are mobilized simultaneously, the thumb individually). |
|
|
| Change from Baseline of Range Of Motion (ROM) |
| 1 day after the treatment |
| Clinical Global Impression (CGI) | 1 day after the treatment |
| 23705119 | Background | Kim EH, Chang MC, Seo JP, Jang SH, Song JC, Jo HM. The effect of a hand-stretching device during the management of spasticity in chronic hemiparetic stroke patients. Ann Rehabil Med. 2013 Apr;37(2):235-40. doi: 10.5535/arm.2013.37.2.235. Epub 2013 Apr 30. |
| 6932734 | Background | Fugl-Meyer AR. Post-stroke hemiplegia assessment of physical properties. Scand J Rehabil Med Suppl. 1980;7:85-93. No abstract available. |
| 23841976 | Background | Bell A, Muller M. Effects of kinesio tape to reduce hand edema in acute stroke. Top Stroke Rehabil. 2013 May-Jun;20(3):283-8. doi: 10.1310/tsr2003-283. |
| 18515964 | Background | Bialosky JE, George SZ, Bishop MD. How spinal manipulative therapy works: why ask why? J Orthop Sports Phys Ther. 2008 Jun;38(6):293-5. doi: 10.2519/jospt.2008.0118. Epub 2008 May 27. No abstract available. |
| 15207508 | Background | Salaffi F, Stancati A, Silvestri CA, Ciapetti A, Grassi W. Minimal clinically important changes in chronic musculoskeletal pain intensity measured on a numerical rating scale. Eur J Pain. 2004 Aug;8(4):283-91. doi: 10.1016/j.ejpain.2003.09.004. |
| 20544156 | Background | Kong KH, Chua KS, Lee J. Symptomatic upper limb spasticity in patients with chronic stroke attending a rehabilitation clinic: frequency, clinical correlates and predictors. J Rehabil Med. 2010 May;42(5):453-7. doi: 10.2340/16501977-0545. |
| 20461330 | Background | Lundstrom E, Smits A, Terent A, Borg J. Time-course and determinants of spasticity during the first six months following first-ever stroke. J Rehabil Med. 2010 Apr;42(4):296-301. doi: 10.2340/16501977-0509. |
| 23719517 | Background | Villafane JH, Valdes K. Combined thumb abduction and index finger extension strength: a comparison of older adults with and without thumb carpometacarpal osteoarthritis. J Manipulative Physiol Ther. 2013 May;36(4):238-44. doi: 10.1016/j.jmpt.2013.05.004. Epub 2013 May 27. |
| 21856077 | Background | Ferreira-Valente MA, Pais-Ribeiro JL, Jensen MP. Validity of four pain intensity rating scales. Pain. 2011 Oct;152(10):2399-2404. doi: 10.1016/j.pain.2011.07.005. |
| 18003049 | Background | Chang CW, Kuo LC, Cheng YT, Su FC, Jou IM, Sun YN. Reliable model-based kinematics analysis system for articulated fingers. Annu Int Conf IEEE Eng Med Biol Soc. 2007;2007:4675-8. doi: 10.1109/IEMBS.2007.4353383. |
| 27847124 | Derived | Borboni A, Villafane JH, Mulle C, Valdes K, Faglia R, Taveggia G, Negrini S. Robot-Assisted Rehabilitation of Hand Paralysis After Stroke Reduces Wrist Edema and Pain: A Prospective Clinical Trial. J Manipulative Physiol Ther. 2017 Jan;40(1):21-30. doi: 10.1016/j.jmpt.2016.10.003. Epub 2016 Nov 12. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |