StrokePhase 3NCT01374152
Perfetti Method in Upper Extremity of Stroke Patients
A Phase 3 study testing cognitive sensory motor training therapy in people with Stroke, run by Prasat Neurological Institute at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- cognitive sensory motor training therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteThailand
- Study dates
- Jul 2008to Jun 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First ever stroke
- Impaired upper extremity function
- Given signed inform consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke
- Being tested
- cognitive sensory motor training therapy
- Keywords
- stroke, upper extremity, rehabilitation, perfetti
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive sensory motor training therapyOther
Also called Perfetti, Cognitive sensory motor training, Stroke, Upper extremity
training method that emphasis on cognition/ sensation/ and motor movement together train every working day 45 minutes per day for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Perfetti | Experimental | Cognitive sensory motor training method for upper extremities rehabilitation every working day, totally training not less than 600 minutes within 4 weeks. Receives: Other: cognitive sensory motor training therapy |
| conventional rehabilitation | No intervention | conventional occupational therapy method for upper extremities rehabilitation every working day, totally training not less than 600 minutes within 4 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (2)
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
Measured: 4 weeks.
Extended Barthel Index
Basic activity of daily living and degree of independence from any form of help.
Measured: 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2011 (estimated)
- Study startJul 2008
- Primary completionMay 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prasat Neurological Institute
- Sponsor type
- Other government
- Collaborators
- Mahidol University
- Responsible party
- Principal investigator, Ratanapat Chanubol, Prasat Neurological Institute
- Investigators
- Ratanapat Chanubol, MD., Principal investigator, Prasat Neurological Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01374152
- Sponsor's protocol ID
- Perfetti
- Status last verified
- Jul 2012
- First submitted
- 14 Jun 2011
- Last updated
- 17 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 12924807Duncan 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.
PubMed 8202977Lyle 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.
PubMed 7333761
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Cognitive Sensory Motor Training Therapy on the Recovery of Upper Extremity Function in Acute Stroke Patients
- ClinicalTrials.gov ID
- NCT01374152
- Acronym / sponsor ID
- Perfetti
- Conditions
- Stroke
- Keywords
- stroke, upper extremity, rehabilitation, perfetti
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Prasat Neurological InstituteOther government
- Collaborators
- Mahidol University
- Study start
- Jul 2008
- Primary completion
- May 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 15 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perfetti | Experimental | Other: cognitive sensory motor training therapyCognitive sensory motor training method for upper extremities rehabilitation every working day, totally training not less than 600 minutes within 4 weeks. |
| conventional rehabilitation | No intervention | –conventional occupational therapy method for upper extremities rehabilitation every working day, totally training not less than 600 minutes within 4 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- First ever stroke
- Impaired upper extremity function
- Given signed inform consent
Key exclusion criteria (6 listed)
- Unstable medical condition
- Any upper extremity functional impairment prior to stroke
- Can not adequately cooperate in training
- Severe communication problems
- Severe cognitive - perceptual deficits
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cognitive sensory motor training therapyAlso: Perfetti, Cognitive sensory motor training, Stroke, Upper extremitytraining method that emphasis on cognition/ sensation/ and motor movement together train every working day 45 minutes per day for 4 weeks. | Other | Perfetti |
Primary outcome
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.
2 secondary outcomes
Box and block test
Time frame: 4 weeks.
Extended Barthel Index
Time frame: 4 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2012.
- Background: PubMed 12924807Wongphaet 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.
- Background: PubMed 8202977Duncan 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.
- Background: PubMed 7333761Lyle 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ratanapat Chanubol, MD. principal investigator
Prasat Neurological Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing cognitive sensory motor training therapy in people with Stroke, run by Prasat Neurological Institute at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Action research arm test (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01374152, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2012; AzTrials last refreshed its copy on 31 Oct 2026.