Robot-assisted Rehabilitation of Hand by Paralysis of the Upper Limb After Stroke

Stroke Clinical Trial

Official title:

Robot-assisted Rehabilitation of Hand by Paralysis of the Upper Limb After Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01936298
• Other study ID #: GLO01
• Status: Completed
• Phase: N/A
• First received: September 2, 2013
• Last updated: October 25, 2013
• Start date: September 2013
• Est. completion date: October 2013

Study information

• Verified date: October 2013
• Source: Habilita, Ospedale di Sarnico
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 80 Years

Eligibility

Inclusion Criteria:

• a history of acute phase of stroke (less than 12 months post onset),

• first stroke episode,

• no history of peripheral nerve injury or musculoskeletal disease in the affected upper extremity,

• no contracture of the affected wrist or fingers (Modified Ashworth<3),

• no history of any invasive procedure (Botulinum toxin type A) for the treatment of spasticity for at least 6 months before the start of this study,

• for P-ROM patients, the absence of active hand movements,

• for the A-ROM patients, the presence of active hand movements.

Exclusion Criteria:

• unstable medical disorders,

• active Complex Regional Pain Syndrome (CRPS),

• severe spatial neglect,

• aphasia,

• cognitive problems.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• A-ROM Continuous Passive Rehabilitation
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).
• P-ROM Continuous Passive Rehabilitation
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).

Locations

Country	Name	City	State
Italy	Habilita, Ospedale di Sarnico	Sarnico	Bergamo

Sponsors (1)

Lead Sponsor	Collaborator
Chiara Mulé

Country where clinical trial is conducted

Italy, 

References & Publications (12)

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. — View Citation

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. — View Citation

Bohannon RW, Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther. 1987 Feb;67(2):206-7. — View Citation

Chang CW, Kuo LC, Cheng YT, Su FC, Jou IM, Sun YN. Reliable model-based kinematics analysis system for articulated fingers. Conf Proc IEEE Eng Med Biol Soc. 2007;2007:4675-8. — View Citation

Ferreira-Valente MA, Pais-Ribeiro JL, Jensen MP. Validity of four pain intensity rating scales. Pain. 2011 Oct;152(10):2399-404. doi: 10.1016/j.pain.2011.07.005. — View Citation

Fugl-Meyer AR. Post-stroke hemiplegia assessment of physical properties. Scand J Rehabil Med Suppl. 1980;7:85-93. — View Citation

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. Erratum in: Ann Rehabil Med. 2013 Jun;37(3):459. Jang, Min Cheol [corrected to Chang, Min Cheol]. — View Citation

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. — View Citation

Lundström E, Smits A, Terént 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. — View Citation

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. — View Citation

Villafañe 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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline of Perimeter edema		1 day after the treatment	No
Secondary	Change from Baseline of Visual analogue scale (VAS)		1 day after the treatment	No
Secondary	Change from Baseline of Modified Ashworth Scale for Grading Spasticity (MAS)		1 day after the treatment	No
Secondary	Change from Baseline of Range Of Motion (ROM)		1 day after the treatment	No
Secondary	Clinical Global Impression (CGI)		1 day after the treatment	No