Study Results
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View full resultsBasic Information
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COMPLETED
NA
18 participants
INTERVENTIONAL
2015-08-31
2018-06-30
Brief Summary
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Hypotheses of this study are:
1. participants who wear the forearm rotation orthosis will demonstrate significantly greater improvement in functional performance and active range of motion of forearm rotators compared to those who do not;
2. all participants who receive the occupational therapy task-oriented approach intervention will demonstrate significant improvement in functional performance; and
3. all participants who receive the occupational therapy task-oriented approach intervention will demonstrate improvement in motor function of the upper extremity.
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Detailed Description
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Orthotic intervention is one therapeutic option for this population. Most orthotic designs for this population are static, developed for sympton reduction or deformity prevention, and aimed at the wrist and hand. However, its effects on spasticity reduction remain controversial. Given that static orthotics may interfere with functional performance and further develop the learned nonuse of the affected limb, a dynamic or mobilization orthosis would be appropriate for enhancing functional performance. Moreover, an orthosis that assists forearm rotation is speculated to enhance functional performance. This study will examine the efficacy of a forearm rotation orthosis combined with the occupational therapy task-oriented approach on functional performance for persons with a hemiparetic arm.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Group A
Forearm rotation orthosis (6 weeks); Forearm rotation orthosis plus occupational therapy task-oriented approach (6 weeks)
occupational therapy task-oriented approach
It is a standard treatment in occupational therapy for persons post-stroke or other neurological conditions. It is an approach that emphasizes client-centered, goal-directed, and functional training for restoration of life roles.
Forearm rotation orthosis
The forearm rotation orthosis is made of Latex-free material and is a custom-molded orthosis designed to assist forearm rotation without limiting functional elbow flexion and extension.
Group B
no treatment (6 weeks); occupational therapy task-oriented approach (6 weeks)
occupational therapy task-oriented approach
It is a standard treatment in occupational therapy for persons post-stroke or other neurological conditions. It is an approach that emphasizes client-centered, goal-directed, and functional training for restoration of life roles.
No treatment
Participants will maintain their daily routines during the no treatment period.
Interventions
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occupational therapy task-oriented approach
It is a standard treatment in occupational therapy for persons post-stroke or other neurological conditions. It is an approach that emphasizes client-centered, goal-directed, and functional training for restoration of life roles.
Forearm rotation orthosis
The forearm rotation orthosis is made of Latex-free material and is a custom-molded orthosis designed to assist forearm rotation without limiting functional elbow flexion and extension.
No treatment
Participants will maintain their daily routines during the no treatment period.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Be 18 years of age or older
* Have sufficient cognitive function to follow three-step verbal instruction and provide independent consent
* Have appropriate trunk and lower extremity function that does not interfere with performance of the upper extremity
* Have at least minimum voluntary movement in the upper extremity (10 degrees of shoulder flex/ abduction, 10 degrees of elbow flexion/extension)
* Not receive any rehabilitative interventions concurrent with the study
Exclusion Criteria
* Capability of voluntarily extending the wrist and fingers through the full range
* Other rehabilitation interventions concurrent with the study
* Have serious uncontrolled medical problems, such as seizures and visual impairment
18 Years
ALL
No
Sponsors
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University of Minnesota
OTHER
Responsible Party
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Principal Investigators
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Chih-Huang Yu, MS
Role: PRINCIPAL_INVESTIGATOR
Rehabilitation Science Program at the University of Minnesota
Virgil Mathiowetz, PhD
Role: STUDY_DIRECTOR
Program in Occupational Therapy, University of Minnesota
Locations
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Children's Rehabilitation Building, University of Minnesota
Minneapolis, Minnesota, United States
Countries
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References
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Braendvik SM, Elvrum AK, Vereijken B, Roeleveld K. Relationship between neuromuscular body functions and upper extremity activity in children with cerebral palsy. Dev Med Child Neurol. 2010 Feb;52(2):e29-34. doi: 10.1111/j.1469-8749.2009.03490.x. Epub 2009 Oct 7.
O'Dwyer NJ, Ada L, Neilson PD. Spasticity and muscle contracture following stroke. Brain. 1996 Oct;119 ( Pt 5):1737-49. doi: 10.1093/brain/119.5.1737.
Dunning K, Berberich A, Albers B, Mortellite K, Levine PG, Hill Hermann VA, Page SJ. A four-week, task-specific neuroprosthesis program for a person with no active wrist or finger movement because of chronic stroke. Phys Ther. 2008 Mar;88(3):397-405. doi: 10.2522/ptj.20070087. Epub 2008 Jan 10.
Page SJ, Levine P, Leonard AC. Modified constraint-induced therapy in acute stroke: a randomized controlled pilot study. Neurorehabil Neural Repair. 2005 Mar;19(1):27-32. doi: 10.1177/1545968304272701.
Page SJ, Levine P, Leonard A, Szaflarski JP, Kissela BM. Modified constraint-induced therapy in chronic stroke: results of a single-blinded randomized controlled trial. Phys Ther. 2008 Mar;88(3):333-40. doi: 10.2522/ptj.20060029. Epub 2008 Jan 3.
Taub E, Uswatte G, King DK, Morris D, Crago JE, Chatterjee A. A placebo-controlled trial of constraint-induced movement therapy for upper extremity after stroke. Stroke. 2006 Apr;37(4):1045-9. doi: 10.1161/01.STR.0000206463.66461.97. Epub 2006 Mar 2.
Watanabe T. The role of therapy in spasticity management. Am J Phys Med Rehabil. 2004 Oct;83(10 Suppl):S45-9. doi: 10.1097/01.phm.0000141130.58285.da.
Lannin NA, Horsley SA, Herbert R, McCluskey A, Cusick A. Splinting the hand in the functional position after brain impairment: a randomized, controlled trial. Arch Phys Med Rehabil. 2003 Feb;84(2):297-302. doi: 10.1053/apmr.2003.50031.
Taub E, Uswatte G, Elbert T. New treatments in neurorehabilitation founded on basic research. Nat Rev Neurosci. 2002 Mar;3(3):228-36. doi: 10.1038/nrn754.
Gillen G. Upper extremity function and management. In G. Gillen (Ed.), Stroke rehabilitation: A function-based approach (3rd ed., pp. 218-279). St. Louis: Mosby, 2011.
Milazzo S, Gillen G. Splinting applications. In G Gillen (Ed.), Stroke rehabilitation: A function-based approach (3rd ed., pp. 326-349). St. Louis: Mosby, 2011
Wolf SL, Winstein CJ, Miller JP, Thompson PA, Taub E, Uswatte G, Morris D, Blanton S, Nichols-Larsen D, Clark PC. Retention of upper limb function in stroke survivors who have received constraint-induced movement therapy: the EXCITE randomised trial. Lancet Neurol. 2008 Jan;7(1):33-40. doi: 10.1016/S1474-4422(07)70294-6.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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1309M42881
Identifier Type: -
Identifier Source: org_study_id
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