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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01374152
Other study ID # Perfetti
Secondary ID
Status Completed
Phase Phase 3
First received June 14, 2011
Last updated July 15, 2012
Start date July 2008
Est. completion date June 2011

Study information

Verified date July 2012
Source Prasat Neurological Institute
Contact n/a
Is FDA regulated No
Health authority Thailand: Ministry of Public Health
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date June 2011
Est. primary completion date May 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
cognitive sensory motor training therapy
training method that emphasis on cognition/ sensation/ and motor movement together train every working day 45 minutes per day for 4 weeks.

Locations

Country Name City State
Thailand Prasat neurological institute Bangkok

Sponsors (2)

Lead Sponsor Collaborator
Prasat Neurological Institute Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 4 weeks No
Secondary 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 4 weeks. No
Secondary Extended Barthel Index Basic activity of daily living and degree of independence from any form of help. 4 weeks. No
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