Enhancing activities of daily living of chronic stroke patients in primary health care by modified constraint-induced movement therapy (HOMECIMT): study protocol for a cluster randomized controlled trial.

Publisher: BioMed Central Country of Publication: England NLM ID: 101263253 Publication Model: Electronic Cited Medium: Internet ISSN: 1745-6215 (Electronic) Linking ISSN: 17456215 NLM ISO Abbreviation: Trials Subsets: MEDLINE

Original Publication: [London] : BioMed Central, 2006-

Activities of Daily Living* ; Home Care Services* ; Primary Health Care* ; Research Design* ; Stroke Rehabilitation*; Exercise Therapy/*methods ; Upper Extremity/*innervation; Chronic Disease ; Clinical Protocols ; Germany ; Humans ; Occupational Therapy ; Physical Examination ; Recovery of Function ; Stroke/diagnosis ; Stroke/physiopathology ; Time Factors ; Treatment Outcome

Background: Stroke leads to constant rehabilitation needs even at the chronic stage. However, although many stroke patients receive physical or occupational therapy in primary health care, treatment prescriptions do not generally specify therapeutic goals; in particular, participation is not established as an explicit therapeutic goal in the ambulatory setting. The primary aim of this study is to evaluate the efficacy of a therapy regimen for chronic stroke patients (modified 'constraint-induced movement therapy (CIMT) at home') with impaired hand or arm function with regard to the prerequisites of participation in everyday activities: a sufficient arm and hand function. 'CIMT at home' will be compared with conventional physical and occupational therapy ('therapy as usual').
Methods/design: The study is a parallel cluster randomized controlled trial with therapy practices as clusters (n = 48). After written consent from the patients (n = 144), the therapists will be randomly assigned to treat either the intervention or the control group. Blinded external assessors will evaluate the patients using standardized outcome measures before and after the intervention, and six months later. The two coprimary endpoint assessments of arm and hand function as prerequisites for participation (defined as equal involvement in activities of daily living) are the motor activity log (quality of arm and hand use) and the Wolf motor function test (arm and hand function). These assessments are made four weeks post-treatment and relativized to baseline performance. Changes in primary outcomes will be analyzed with mixed models, which consider the hierarchical structure of the data and will be adjusted to the baseline measurements and sex. The primary analysis will be the comparison of the two randomized groups, with respect to the adjusted averages for each of the two coprimary endpoints. To keep an overall significance level of 5%, the two endpoints will be tested at the significance level of 5% each in hierarchical order.
Discussion: A modification of the CIMT, feasible in the patients' homes (CIMT at home), appears to be a promising therapeutic approach in the ambulatory care of chronic stroke patients. With proven efficacy and practicality, a participation-oriented, stroke-specific treatment would be available in primary care.
Trial Registration: ClinicalTrials.gov NCT01343602.

Clin Rehabil. 2002 Jun;16(4):420-8. (PMID: 12061477)
Nervenarzt. 2003 Oct;74(10):841-9. (PMID: 14551687)
Restor Neurol Neurosci. 2004;22(3-5):269-77. (PMID: 15502271)
Lancet Neurol. 2008 Jan;7(1):33-40. (PMID: 18077218)
Clin Rehabil. 2012 Mar;26(3):209-23. (PMID: 22070990)
Stroke. 2006 Apr;37(4):1045-9. (PMID: 16514097)
Arch Phys Med Rehabil. 2008 Sep;89(9):1693-700. (PMID: 18760153)
Neurorehabil Neural Repair. 2005 Sep;19(3):238-49. (PMID: 16093415)
Restor Neurol Neurosci. 2009;27(6):673-80. (PMID: 20042791)
Fortschr Neurol Psychiatr. 2001 Jun;69(6):284-90. (PMID: 11455911)
BMJ. 2004 Mar 20;328(7441):702-8. (PMID: 15031246)
J Psychiatr Res. 1975 Nov;12(3):189-98. (PMID: 1202204)
Pain. 1992 Aug;50(2):133-149. (PMID: 1408309)
JAMA. 2006 Nov 1;296(17):2095-104. (PMID: 17077374)
Stroke. 1999 Nov;30(11):2369-75. (PMID: 10548673)
Cochrane Database Syst Rev. 2009 Oct 07;(4):CD004433. (PMID: 19821326)
Gerontologist. 1969 Autumn;9(3):179-86. (PMID: 5349366)
Fortschr Neurol Psychiatr. 2002 Dec;70(12):657-62. (PMID: 12459947)
Neuroimage. 2006 Sep;32(3):1216-20. (PMID: 16809053)
Eur J Phys Rehabil Med. 2010 Dec;46(4):537-44. (PMID: 21224785)
Neurorehabil Neural Repair. 2009 Jun;23(5):429-34. (PMID: 19289487)
Arch Phys Med Rehabil. 1993 Apr;74(4):347-54. (PMID: 8466415)
Am J Occup Ther. 1985 Jun;39(6):386-91. (PMID: 3160243)

ClinicalTrials.gov NCT01343602

Date Created: 20131016 Date Completed: 20141104 Latest Revision: 20240321

20250114

PMC3853576

10.1186/1745-6215-14-334

24124993