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

NCT01936298 | Completed DMC

• 1 other identifier: GLO01
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke

Keywords

Hand Edema; Exercise Therapy

Outcome Measures

Primary Outcomes (1)

• Change from Baseline of Perimeter edema

  1 day after the treatment

Secondary Outcomes (4)

• 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

• Change from Baseline of Range Of Motion (ROM)

  1 day after the treatment

• Clinical Global Impression (CGI)

  1 day after the treatment

Study Arms (2)

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.

Device: A-ROM Continuous Passive Rehabilitation

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.

Device: P-ROM Continuous Passive Rehabilitation

Interventions

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).

Also known as: Continuous Passive Motion device for hand: Gloreha

A-ROM Continuous Passive Rehabilitation

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).

Also known as: Continuous Passive Motion device for hand: Gloreha

P-ROM Continuous Passive Rehabilitation

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• unstable medical disorders,
• active Complex Regional Pain Syndrome (CRPS),
• severe spatial neglect,
• aphasia,
• cognitive problems.

Sponsors & Collaborators

• Chiara Mulé: lead

Study Sites (1)

Habilita, Ospedale di Sarnico

Sarnico, Bergamo, 24067, Italy

Location

Related Publications (13)

• 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.

  PMID: 21964036 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.

  PMID: 3809245 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.

  PMID: 23705119 BACKGROUND

• Fugl-Meyer AR. Post-stroke hemiplegia assessment of physical properties. Scand J Rehabil Med Suppl. 1980;7:85-93. No abstract available.

  PMID: 6932734 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.

  PMID: 23841976 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.

  PMID: 18515964 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.

  PMID: 15207508 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.

  PMID: 20544156 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.

  PMID: 20461330 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.

  PMID: 23719517 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.

  PMID: 21856077 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.

  PMID: 18003049 BACKGROUND

• 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.

  PMID: 27847124 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Chiara Mulé, MD

  Habilita, Ospedale di Sarnico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physiatrist Physician

Study Record Dates

• First Submitted: September 2, 2013
• First Posted: September 6, 2013
• Study Start: September 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: October 28, 2013

Record last verified: 2013-10

Locations

IT (1)