Stroke Syndrome Sequela SpasticityNCT04869748
Perfetti Method on Upper Extremity Spasticity of Stroke Patient
A study testing Perfetti method and passive stretching in people with Stroke Syndrome Sequela Spasticity, run by Mahidol University at 1 site in Thailand.
Trial summary
This study objective is to study the immediate effect of Perfetti Method in reducing spasticity of upper extremity in stroke patients at the Department of Physical Medicine,Faculty of Medicine Ramathibodhi Hospital, Thailand. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke Syndrome Sequela Spasticity
- What is being tested?
- Perfetti method and passive stretching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteThailand
- Study dates
- 15 Nov 2018to 25 Jul 2019
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- stroke confirmed by history, physical examination and imaging
- having spastic elbow flexors MAS ≥ 2
- full range of motion (ROM) of elbow from 0-150 degree
- Montreal cognitive assessment (MOCA) score ≥ 23
- having had problem from spasticity
- age ≥ 18 years old
- given written informed consent to participate
Who cannot join
- having been treated with Perfetti method
- previous soft tissue release of involved elbow flexor
- having wound or inflammation on treatment area
- unstable medical condition
- other conditions affecting tone of elbow flexor, e.g. nerve injury
- not willing to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial Study of Perfetti Method on Upper Extremity Spasticity of Stroke Patient
This study objective is to study the immediate effect of Perfetti Method in reducing spasticity of upper extremity in stroke patients at the Department of Physical Medicine,Faculty of Medicine Ramathibodhi Hospital, Thailand. Participants were randomized into experimental group who received therapy according to the Perfetti method, and controlled group who underwent passive stretching exercise. Duration of treatment was 15 minutes for every case, regardless of the treatment. Evaluation of spasticity immediately before and after treatment according to Modified Tardieu scale (MTS) and Modified Ashworth Scale (MAS) by same blinded assessor.
Read the detailed description
- This study was a single center, single-blind randomized controlled trial study conducted in Thailand during June 2018 and September 2019.
- After approval by Human Research Ethics Committee, Faculty of Medicine Ramathibodi Hospital, Mahidol University, stroke patients with spasticity of upper extremity at the Department of Rehabilitation Medicine, Faculty of Medicine Ramathibodhi Hospital were recruited.
- Participants were assigned to experimental group and control group by researcher using computer randomization.
- Outcome assessor was blinded to the allocations.
- Demographic data including gender, ages, type of stroke, hemiparesis side, time since stroke, duration of upper limb spasticity, Brunnstrom stage of upper extremity, joint proprioception of elbow joint, Barthel index, spasticity impact score, and current treatment (conventional physical therapy, antispastic medication, botulinum toxin/ Phenol injection) were collected. A simplified questionnaire was used to determine spasticity impact score.
- All therapy sessions were conducted by the same PMR residence, who was trained by an experienced occupational therapist for 1 session and further practiced under supervision for 10 sessions.
- The primary outcome was the improvement of the angle of muscle reaction (R1 angle) in Modified Tardieu Scale (MTS).
- The secondary outcomes were the number of participants with improvement of quality of muscle action in MTS ≥1 and the number of participants with improvement of Modified Ashworth Scale (MAS) ≥1.
- Sample size was calculated using delta change of R1 angle of MTS in 10 subjects pilot study, with alpha = 0.05 and beta = 0.1. The total number of sample size is 7 subjects per group, 14 subjects in total.
- In Experimental group, each participant received a 15-minute session of Perfetti method on affected elbow flexor. Participant was blindfolded, while lying flat in a quiet and comfortable room. Participants were asked to concentrate on the position of their elbows. Protocol has 4 steps of training as shown in Table 1, starting from 2 positions of elbow and ending with 5 positions. After therapist passively moved elbow joint to a position, participant guessed the position of his/her elbow. If the answers were correct consecutively for 10 times, the therapist increased the number of positions according to the protocol.
- In control group, each participant received gentle passive stretching of elbow flexor and maintained in full elbow extension position for 15 minutes.
- For statistical analysis, program SPSS version 21 was used to calculate mean and standard deviation (mean±SD) for continuous variables, and percent and median for categorical variables. Paired T-test and independent T-test were used to compared result in the same group and between groups, respectively. Results were considered significant when p <0.05. The difference in quality of muscle reaction of MTS and MAS was deemed meaningful if the reduction was ≥ 1 level.
- Conditions
- Stroke Syndrome Sequela Spasticity
- Being tested
- Perfetti method, passive stretching
- Keywords
- Upper extremity spasticity, stroke, Perfetti method, passive stretching exercise
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perfetti methodOther
Also called cognitive sensorimotor training therapy
- Participant was blindfolded, while lying flat in a quiet and comfortable room.
- Participants received a 15-minute session of Perfetti method on affected elbow flexor.
- Participants were asked to concentrate on the position of their elbows.
- Protocol has 4 steps of training starting from 2 positions; full flexion and full extension 3 positions; full flexion, elbow flexion 90 degree and full extension 4 positions; full flexion, elbow flexion 110-140 degree, elbow flexion 45-60 degree and full extension 5 positions; full flexion, elbow flexion 110-140 degree, elbow flexion 90 degree, elbow flexion 45-60 degree and full extension of elbow.
- After therapist passively moved elbow joint to a position, participant guessed the position of his/her elbow. If the answers were correct consecutively for 10 times, the therapist increased the number of positions according to the protocol.
passive stretchingOther
- Participant was blindfolded, while lying flat in a quiet and comfortable room.
- Each participant received gentle passive stretching of elbow flexor and maintained in full elbow extension position for 15 minutes.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | After recruitment, signed inform consent and allocation, researcher collected demographic data of each participant. First outcome assessment was done before session. Participants received a 15-minute session of Perfetti method on affected elbow flexor.Immediate after session, last outcome assessment was collected. Receives: Other: Perfetti method |
| control group | Active comparator | After recruitment, signed inform consent and allocation, researcher collected demographic data of each participant. First outcome assessment was done before session. Participants received a 15-minute session of Passive stretching on affected elbow flexor.Immediate after session, last outcome assessment was collected. Receives: Other: passive stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
angle of muscle reaction (R1 angle) in Modified Tardieu Scale (MTS)
R1 angle in MTS post-session(degree) minus R1 angle in MTS pre-session. Outcome was report in degree, from 0 to 180 degree. Higher value is better outcome.
Measured: immediate after intervention
Secondary outcomes (2)
quality of muscle action in MTS
Number of participants with improvement of quality of muscle action in MTS ≥1. Higher number is better outcome.
Quality of muscle reaction in MTS is an ordinal scale to assess spasticity, consist of 6 levels, 0, 1, 2, 3, 4 and 5. The worst level of spasticity is 5 and the best level is 0. The improvement of quality of muscle reaction means change in level of quality of muscle reaction from higher to lower ≥1 level .
Measured: immediate after intervention
Modified Ashworth Scale (MAS)
Number of participants with improvement of Modified Ashworth Scale (MAS) ≥1 level. Higher number of participants is better outcome.
MAS is an ordinal scale to assess spasticity, consist of 6 levels, 0, 1, 1+, 2, 3 and 4. The worst level of spasticity is 4 and the best level is 0. The improvement of MAS means change in level of MAS from higher to lower ≥1 level .
Measured: immediate after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start15 Nov 2018
- Primary completion25 Jul 2019
- Study completion25 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke Syndrome Sequela SpasticityStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- single blind randomized controlled trial study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pimchanok Tuakta, MD, PMR, Principal investigator, Department of rehabilitation medicine, Faculty of Medicine Ramathibodi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04869748
- Sponsor's protocol ID
- MURA2018/441
- Status last verified
- May 2021
- First submitted
- 28 Apr 2021
- Last updated
- 6 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Study of Perfetti Method on Upper Extremity Spasticity of Stroke Patient
- ClinicalTrials.gov ID
- NCT04869748
- Acronym / sponsor ID
- MURA2018/441
- Conditions
- Stroke Syndrome Sequela Spasticity
- Keywords
- Upper extremity spasticity, stroke, Perfetti method, passive stretching exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 15 Nov 2018 (actual)
- Primary completion
- 25 Jul 2019 (actual)
- Study completion
- 25 Jul 2019 (actual)
- First posted
- 3 May 2021 (actual)
- 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.
This study objective is to study the immediate effect of Perfetti Method in reducing spasticity of upper extremity in stroke patients at the Department of Physical Medicine,Faculty of Medicine Ramathibodhi Hospital, Thailand. Participants were randomized into experimental group who received therapy according to the Perfetti method, and controlled group who underwent passive stretching exercise. Duration of treatment was 15 minutes for every case, regardless of the treatment. Evaluation of spasticity immediately before and after treatment according to Modified Tardieu scale (MTS) and Modified Ashworth Scale (MAS) by same blinded assessor.
Detailed description
- This study was a single center, single-blind randomized controlled trial study conducted in Thailand during June 2018 and September 2019.
- After approval by Human Research Ethics Committee, Faculty of Medicine Ramathibodi Hospital, Mahidol University, stroke patients with spasticity of upper extremity at the Department of Rehabilitation Medicine, Faculty of Medicine Ramathibodhi Hospital were recruited.
- Participants were assigned to experimental group and control group by researcher using computer randomization.
- Outcome assessor was blinded to the allocations.
- Demographic data including gender, ages, type of stroke, hemiparesis side, time since stroke, duration of upper limb spasticity, Brunnstrom stage of upper extremity, joint proprioception of elbow joint, Barthel index, spasticity impact score, and current treatment (conventional physical therapy, antispastic medication, botulinum toxin/ Phenol injection) were collected. A simplified questionnaire was used to determine spasticity impact score.
- All therapy sessions were conducted by the same PMR residence, who was trained by an experienced occupational therapist for 1 session and further practiced under supervision for 10 sessions.
- The primary outcome was the improvement of the angle of muscle reaction (R1 angle) in Modified Tardieu Scale (MTS).
- The secondary outcomes were the number of participants with improvement of quality of muscle action in MTS ≥1 and the number of participants with improvement of Modified Ashworth Scale (MAS) ≥1.
- Sample size was calculated using delta change of R1 angle of MTS in 10 subjects pilot study, with alpha = 0.05 and beta = 0.1. The total number of sample size is 7 subjects per group, 14 subjects in total.
- In Experimental group, each participant received a 15-minute session of Perfetti method on affected elbow flexor. Participant was blindfolded, while lying flat in a quiet and comfortable room. Participants were asked to concentrate on the position of their elbows. Protocol has 4 steps of training as shown in Table 1, starting from 2 positions of elbow and ending with 5 positions. After therapist passively moved elbow joint to a position, participant guessed the position of his/her elbow. If the answers were correct consecutively for 10 times, the therapist increased the number of positions according to the protocol.
- In control group, each participant received gentle passive stretching of elbow flexor and maintained in full elbow extension position for 15 minutes.
- For statistical analysis, program SPSS version 21 was used to calculate mean and standard deviation (mean±SD) for continuous variables, and percent and median for categorical variables. Paired T-test and independent T-test were used to compared result in the same group and between groups, respectively. Results were considered significant when p <0.05. The difference in quality of muscle reaction of MTS and MAS was deemed meaningful if the reduction was ≥ 1 level.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- single blind randomized controlled trial study
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: Perfetti methodAfter recruitment, signed inform consent and allocation, researcher collected demographic data of each participant. First outcome assessment was done before session. Participants received a 15-minute session of Perfetti method on affected elbow flexor.Immediate after session, last outcome assessment was collected. |
| control group | Active comparator | Other: passive stretchingAfter recruitment, signed inform consent and allocation, researcher collected demographic data of each participant. First outcome assessment was done before session. Participants received a 15-minute session of Passive stretching on affected elbow flexor.Immediate after session, last outcome assessment was collected. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- stroke confirmed by history, physical examination and imaging
- having spastic elbow flexors MAS ≥ 2
- full range of motion (ROM) of elbow from 0-150 degree
- Montreal cognitive assessment (MOCA) score ≥ 23
- having had problem from spasticity
Key exclusion criteria (6 listed)
- having been treated with Perfetti method
- previous soft tissue release of involved elbow flexor
- having wound or inflammation on treatment area
- unstable medical condition
- other conditions affecting tone of elbow flexor, e.g. nerve injury
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 |
|---|---|---|
| Perfetti methodAlso: cognitive sensorimotor training therapy* Participant was blindfolded, while lying flat in a quiet and comfortable room. * Participants received a 15-minute session of Perfetti method on affected elbow flexor. * Participants were asked to concentrate on the position of their elbows. * Protocol has 4 steps of training starting from 2 positions; full flexion and full extension 3 positions; full flexion, elbow flexion 90 degree and full extension 4 positions; full flexion, elbow flexion 110-140 degree, elbow flexion 45-60 degree and full extension 5 positions; full flexion, elbow flexion 110-140 degree, elbow flexion 90 degree, elbow flexion 45-60 degree and full extension of elbow. * After therapist passively moved elbow joint to a position, participant guessed the position of his/her elbow. If the answers were correct consecutively for 10 times, the therapist increased the number of positions according to the protocol. | Other | experimental group |
| passive stretching* Participant was blindfolded, while lying flat in a quiet and comfortable room. * Each participant received gentle passive stretching of elbow flexor and maintained in full elbow extension position for 15 minutes. | Other | control group |
Primary outcome
angle of muscle reaction (R1 angle) in Modified Tardieu Scale (MTS)
Time frame: immediate after intervention
R1 angle in MTS post-session(degree) minus R1 angle in MTS pre-session. Outcome was report in degree, from 0 to 180 degree. Higher value is better outcome.
2 secondary outcomes
quality of muscle action in MTS
Time frame: immediate after intervention
Modified Ashworth Scale (MAS)
Time frame: immediate after intervention
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 6 May 2021.
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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.
Pimchanok Tuakta, MD, PMR principal investigator
Department of rehabilitation medicine, Faculty of Medicine Ramathibodi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perfetti method and passive stretching in people with Stroke Syndrome Sequela Spasticity, run by Mahidol University 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 7 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 6 May 2021. 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.
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?
angle of muscle reaction (R1 angle) in Modified Tardieu Scale (MTS) (time frame: immediate after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 May 2021.