Comparative effects of Carlo Perfetti Method and Proprioceptive Neuromuscular Facilitation technique on upper limb motor function in patients with subacute stroke
To evaluate the effect of Carlo Perfetti Method on improving the upper extremity motor function in subacute stroke patients.
Design
The study design will be the Randomized clinical trial design
Settings and conduct
Allied Hospital Faisalabad, District Head Quarter Hospital Faisalabad and Faisal Hospital Faisalabad.
Participants/Inclusion and exclusion criteria
The inclusion criteria will be the patient age range from 40 to 80 years, will include both genders: male and female, Patients with Modified Ashworth scale value is 2, patients having Mini-mental scale score >24, the Motricity index score should be < 99 and MCA Stroke confirmed with MRI.
The exclusion criteria will be the patients who are already seeking any physiotherapy treatment, Having any wound or inflammation on upper extremity, Unstable medical condition, Any peripheral nerve injury before stroke and Before stroke any upper limb musculoskeletal functional impairments.
Intervention groups
Group A will be treated by the Carlo Perfetti Method and Group B will be treated by the Proprioceptive Neuromuscular Facilitation technique (PNF).
Main outcome variables
Motor function of upper limb, Spasticity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230530058341N1
Registration date:2023-09-27, 1402/07/05
Registration timing:prospective
Last update:2023-09-27, 1402/07/05
Update count:0
Registration date
2023-09-27, 1402/07/05
Registrant information
Name
Hafsa Naz
Name of organization / entity
The University of Faisalabad
Country
Pakistan
Phone
+92 41 8868326
Email address
clinical.trainer.339@tuf.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-28, 1402/07/06
Expected recruitment end date
2023-12-10, 1402/09/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative effects of Carlo Perfetti Method and Proprioceptive Neuromuscular Facilitation technique on upper limb motor function in patients with subacute stroke
Public title
Comparative effects of Carlo Perfetti Method and Proprioceptive Neuromuscular Facilitation technique on upper limb motor function in patients with subacute stroke
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age range from 40 to 80 years
Both genders: male and female
Modified Ashworth scale 2
Mini-mental scale > 24
Motricity index scale < 99
MCA Stroke confirmed with MRI
Exclusion criteria:
Already seeking any physiotherapy treatment
Having any wound or inflammation on upper extremity
Unstable medical condition
Any peripheral nerve injury
Before stroke any upper limb musculoskeletal functional impairments
Age
From 40 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done with Lottery method and by the help of computerized generator, allocations will done to randomly allocate the participants in two groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants will not know if they will be allocated in Carlo Perfetti Method group or in Proprioceptive Neuromuscular Facilitation Technique group for the Treatment.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of The University of Faisalabad
Street address
West Canal Road, Faisalabad
City
Faisalabad
Postal code
37610
Approval date
2023-03-24, 1402/01/04
Ethics committee reference number
TUF/DR/SA/MSPP/2023/242
Health conditions studied
1
Description of health condition studied
Stroke
ICD-10 code
Z82.3
ICD-10 code description
Family history of stroke
Primary outcomes
1
Description
Spasticity
Timepoint
At baseline, after second week of treatment, after fourth week of treatment, after sixth week of treatment, after eighth week of treatment and after tenth week of treatment
Method of measurement
Modified Ashworth Scale
Secondary outcomes
1
Description
Motor function of upper extremity
Timepoint
At baseline, after second week of treatment, after fourth week of treatment, after sixth week of treatment, after eighth week of treatment and after tenth week of treatment
Method of measurement
Motricity Index Scale
2
Description
Arm motor performance and movement quality
Timepoint
At baseline, after second week of treatment, after fourth week of treatment, after sixth week of treatment, after eighth week of treatment and after tenth week of treatment
Method of measurement
Motor Evaluation Scale for Upper Extremity
Intervention groups
1
Description
Intervention group: Carlo Perfetti Method; As part of the treatment process, the patient will be blindfolded and the physical therapist will began to passively move the patient’s involved limb. The therapist will then ask the patient to sense and guess the movement of the limb that will be performed by the therapist. To further enhance the rehabilitation process, the therapist will use a pattern of lines drawn on a page and will ask the patient to trace those lines with their hand, either actively or passively. This exercise will help to improve the patient's proprioception, which is their sense of body position and movement. By tracing the lines with their hand, the patient will be able to get a better sense of their limb's position and movement, which can be helpful in improving their coordination and motor function.
Category
Rehabilitation
2
Description
Intervention group: Proprioceptive Neuromuscular Facilitation Technique; In this group, the participants will be given the Rhythmic Initiation technique of Proprioceptive Neuromuscular Facilitation (PNF) technique. This technique will involve progressively transitioning from passive range of motion to active resisted movements of the limb. During the rehabilitation process, a series of movements will be performed, starting with voluntary relaxation and progressing to passive movements, active assisted and active resisted movements before finally transitioning to active movements. Verbal commands will be used to set the pace and rhythm of the movements, and light tracking will be incorporated during the resistive phase to facilitate movement. These exercises are design to improve motor function and range of motion and are customize to meet the specific needs of the patient. Rhythmic initiation helps in the initiation of the motion and improve the coordination and sense of the motion.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Allied Hospital Faisalabad
Full name of responsible person
Hafsa Naz
Street address
Jail Road adjacent to Faisalabad Medical University, Near Sargodha Road, Faisalabad.
673-A Lower Canal Rd E, Block A People's Colony No 1, Faisalabad
City
Faisalabad
Postal code
03822
Phone
+92 41 8719677
Email
info@faisalhospital.com
Web page address
https://www.faisalhospital.com/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Hafsa Naz
Street address
P-526, St no 2, Aslam market, Hajveri town, millat road, Faisalabad
City
Faisalabad
Postal code
38500
Phone
+92 304 1633066
Email
hafsanaz020@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Faisalabad
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Hafsa Naz
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
P-526, St no 2, Aslam market, Hajveri town, millat road, Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38500
Phone
+92 41 8848211
Email
hafsanaz020@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Hafsa Naz
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
P-526, St no 2, Aslam market, Hajveri town, millat road, Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38500
Phone
+92 41 8848211
Email
clinical.trainer.339@tuf.edu.pk
Person responsible for updating data
Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Hafsa Naz
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
P-526, St no 2, Aslam market, Hajveri town, millat road, Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38500
Phone
+92 41 8848211
Email
clinical.trainer.339@tuf.edu.pk
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The Study Protocol will be followed, The Statistical Analysis Plan will be used, Informed Consent Form will be taken from participants, it will be a Clinical Study Report.
When the data will become available and for how long
The data will be available after six months.
To whom data/document is available
The data will be available for all the researchers and the Institutes.
Under which criteria data/document could be used
Data will be shared for more clinical research.
From where data/document is obtainable
The Data will be shared via Email addresses.
What processes are involved for a request to access data/document