Perfetti Method on Upper Extremity Spasticity of Stroke Patient

NCT04869748 | Completed

• 1 other identifier: MURA2018/441
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke Syndrome Sequela Spasticity

Keywords

Upper extremity spasticity; stroke; Perfetti method; passive stretching exercise

Outcome Measures

Primary Outcomes (1)

• 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.

  immediate after intervention

Secondary Outcomes (2)

• quality of muscle action in MTS

  immediate after intervention

• Modified Ashworth Scale (MAS)

  immediate after intervention

Study Arms (2)

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.

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.

Other: passive stretching

Interventions

Perfetti method OTHER

* 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.

Also known as: cognitive sensorimotor training therapy

experimental group

passive stretching OTHER

* 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.

control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Ramathibodi Hospital

Bangkok, 10400, Thailand

Location

MeSH Terms

Conditions

Stroke

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Pimchanok Tuakta, MD, PMR

  Department of rehabilitation medicine, Faculty of Medicine Ramathibodi Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: single blind randomized controlled trial study

Study Record Dates

• First Submitted: April 28, 2021
• First Posted: May 3, 2021
• Study Start: November 15, 2018
• Primary Completion: July 25, 2019
• Study Completion: July 25, 2019
• Last Updated: May 6, 2021

Record last verified: 2021-05

Locations

TH (1)