- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01374152
Perfetti Method in Upper Extremity of Stroke Patients
July 15, 2012 updated by: Ratanapat Chanubol, Prasat Neurological Institute
A Randomized Controlled Trial of Cognitive Sensory Motor Training Therapy on the Recovery of Upper Extremity Function in Acute Stroke Patients
The cognitive sensory motor training therapy (Perfetti's technique) might be more effectiveness than conventional occupational therapy on upper extremity function recovery after acute stroke patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Globally, stroke is the second leading cause of death above the age of 60 years, and the fifth leading cause of death in people aged 15 to 59 years old.
Upper extremities problem is still faced with poor prognosis for recovery.
Cognitive sensory motor training therapy (Perfetti's technique) might be better helped for recovery of upper extremity function in stroke than conventional therapy.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bangkok, Thailand, 10400
- Prasat Neurological Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- First ever stroke
- Impaired upper extremity function
- Given signed inform consent
Exclusion Criteria:
- Unstable medical condition
- Any upper extremity functional impairment prior to stroke
- Can not adequately cooperate in training
- Severe communication problems
- Severe cognitive - perceptual deficits
- Fixed contracture more than 30 degree in every upper extremity joint
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Perfetti
Cognitive sensory motor training method for upper extremities rehabilitation every working day, totally training not less than 600 minutes within 4 weeks.
|
training method that emphasis on cognition/ sensation/ and motor movement together train every working day 45 minutes per day for 4 weeks.
Other Names:
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No Intervention: conventional rehabilitation
conventional occupational therapy method for upper extremities rehabilitation every working day, totally training not less than 600 minutes within 4 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Action research arm test
Time Frame: 4 weeks
|
The Action research arm test used for assess the impairment of upper limb function.
ARAT has ordinal 4-point scale (0-3) in 19 items.
Totally 57 scores.
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4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Box and block test
Time Frame: 4 weeks.
|
For evaluated gross manual dexterity, consist of two adjacent boxes of the same size.
Between the two boxes, there is a partition.
It is recorded the number of wooden block that can be transported from one compartment of a box to another within 60 seconds
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4 weeks.
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Extended Barthel Index
Time Frame: 4 weeks.
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Basic activity of daily living and degree of independence from any form of help.
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4 weeks.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ratanapat Chanubol, MD., Prasat Neurological Institute
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Lyle RC. A performance test for assessment of upper limb function in physical rehabilitation treatment and research. Int J Rehabil Res. 1981;4(4):483-92. doi: 10.1097/00004356-198112000-00001. No abstract available.
- Duncan PW, Goldstein LB, Horner RD, Landsman PB, Samsa GP, Matchar DB. Similar motor recovery of upper and lower extremities after stroke. Stroke. 1994 Jun;25(6):1181-8. doi: 10.1161/01.str.25.6.1181.
- Wongphaet P, Butrach W, Sangkrai S, Jitpraphai C. Improved function of hemiplegic upper extremity after cognitive sensory motor training therapy in chronic stroke patients: preliminary report of a case series. J Med Assoc Thai. 2003 Jun;86(6):579-84.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2008
Primary Completion (Actual)
May 1, 2011
Study Completion (Actual)
June 1, 2011
Study Registration Dates
First Submitted
June 14, 2011
First Submitted That Met QC Criteria
June 14, 2011
First Posted (Estimate)
June 15, 2011
Study Record Updates
Last Update Posted (Estimate)
July 17, 2012
Last Update Submitted That Met QC Criteria
July 15, 2012
Last Verified
July 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Perfetti
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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