Clinical trial NCT04869748: Perfetti Method on Upper Extremity Spasticity of Stroke Patient
Official title: A Randomized Controlled Trial Study of Perfetti Method on Upper Extremity Spasticity of Stroke Patient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke Syndrome Sequela Spasticity
Keywords: Upper extremity spasticity
stroke
Perfetti method
passive stretching exercise
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2021-05-03
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: single blind randomized controlled trial study
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. stroke confirmed by history, physical examination and imaging
2. having spastic elbow flexors MAS ≥ 2
3. full range of motion (ROM) of elbow from 0-150 degree
4. Montreal cognitive assessment (MOCA) score ≥ 23
5. having had problem from spasticity
6. age ≥ 18 years old
7. given written informed consent to participate

Exclusion Criteria:

1. having been treated with Perfetti method
2. previous soft tissue release of involved elbow flexor
3. having wound or inflammation on treatment area
4. unstable medical condition
5. other conditions affecting tone of elbow flexor, e.g. nerve injury
6. not willing to participate

Primary outcomes:
measure: angle of muscle reaction (R1 angle) in Modified Tardieu Scale (MTS)
timeFrame: immediate after intervention
Secondary outcomes:
measure: quality of muscle action in MTS
timeFrame: immediate after intervention
measure: Modified Ashworth Scale (MAS)
timeFrame: immediate after intervention
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital
Study officials:
affiliation: Department of rehabilitation medicine, Faculty of Medicine Ramathibodi Hospital
name: Pimchanok Tuakta, MD, PMR
role: PRINCIPAL_INVESTIGATOR
References: