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Perfetti Method in Upper Extremity of Stroke Patients

Primary Purpose

Stroke

Status
Completed
Phase
Phase 3
Locations
Thailand
Study Type
Interventional
Intervention
cognitive sensory motor training therapy
Sponsored by
Prasat Neurological Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, upper extremity, rehabilitation, perfetti

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Prasat neurological institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Perfetti

conventional rehabilitation

Arm Description

Cognitive sensory motor training method for upper extremities rehabilitation every working day, totally training not less than 600 minutes within 4 weeks.

conventional occupational therapy method for upper extremities rehabilitation every working day, totally training not less than 600 minutes within 4 weeks.

Outcomes

Primary Outcome Measures

Action research arm test
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.

Secondary Outcome Measures

Box and block test
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
Extended Barthel Index
Basic activity of daily living and degree of independence from any form of help.

Full Information

First Posted
June 14, 2011
Last Updated
July 15, 2012
Sponsor
Prasat Neurological Institute
Collaborators
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT01374152
Brief Title
Perfetti Method in Upper Extremity of Stroke Patients
Official Title
A Randomized Controlled Trial of Cognitive Sensory Motor Training Therapy on the Recovery of Upper Extremity Function in Acute Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Prasat Neurological Institute
Collaborators
Mahidol University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, upper extremity, rehabilitation, perfetti

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Perfetti
Arm Type
Experimental
Arm Description
Cognitive sensory motor training method for upper extremities rehabilitation every working day, totally training not less than 600 minutes within 4 weeks.
Arm Title
conventional rehabilitation
Arm Type
No Intervention
Arm Description
conventional occupational therapy method for upper extremities rehabilitation every working day, totally training not less than 600 minutes within 4 weeks.
Intervention Type
Other
Intervention Name(s)
cognitive sensory motor training therapy
Other Intervention Name(s)
Perfetti, Cognitive sensory motor training, Stroke, Upper extremity
Intervention Description
training method that emphasis on cognition/ sensation/ and motor movement together train every working day 45 minutes per day for 4 weeks.
Primary Outcome Measure Information:
Title
Action research arm test
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Box and block test
Description
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
Time Frame
4 weeks.
Title
Extended Barthel Index
Description
Basic activity of daily living and degree of independence from any form of help.
Time Frame
4 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ratanapat Chanubol, MD.
Organizational Affiliation
Prasat Neurological Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prasat neurological institute
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
12924807
Citation
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.
Results Reference
background
PubMed Identifier
8202977
Citation
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.
Results Reference
background
PubMed Identifier
7333761
Citation
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.
Results Reference
background

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Perfetti Method in Upper Extremity of Stroke Patients

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