The effects of forearm selective cutaneous anesthesia combined with active sensory re-education on sensory motor function of upper limb in chronic stroke survivors: a prelimi
to investigate the effect of using active sensory retraining using the Win-Perry and Delon method along with selective afferent denervation of the affected forearm on the sensory-motor function of the upper limb in people with chronic stroke.
Design
one group before/after trial
Settings and conduct
The therapeutic interventions consisted of 12 60-minute sessions, consisting of 40 minutes of routine occupational therapy and 20 minutes of sensory retraining, every other day. The patients' occupational therapy included the use of infrared radiation for the upper limb for 10 minutes to prepare the tissue, followed by stretching techniques for spastic muscles such as wrist and finger flexors and biceps, followed by active wrist and finger extension exercises and thumb apposition.
Sensory retraining exercises are graded and include localization and stereognosis in therapy sessions.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with cortical ischemic stroke within the middle cerebral artery in the age of 20-65 years of age. ability to extend the fingers
Exclusion criteria : having cognitive and visual deficits, neurological surgeries and other neurological diseases, neglect in right hemisphere lesions
Intervention groups
Local anesthesia in the forearm with sensory retraining technique
Main outcome variables
fugl Meyer Assessment: This assessment is a stroke-specific performance-based index designed to assess motor function, balance, sensation, and joint function in patients with post-stroke hemiplegia.
Semmes-Weinstein Monofilament: This discrimination test is used to assess the threshold for stimulation required to perceive light touch to deep pressure.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250527065928N1
Registration date:2025-08-09, 1404/05/18
Registration timing:registered_while_recruiting
Last update:2025-08-09, 1404/05/18
Update count:0
Registration date
2025-08-09, 1404/05/18
Registrant information
Name
Amin Mahdizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3658 0251
Email address
mahdizadeha@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-07-06, 1404/04/15
Expected recruitment end date
2025-12-21, 1404/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of forearm selective cutaneous anesthesia combined with active sensory re-education on sensory motor function of upper limb in chronic stroke survivors: a prelimi
Public title
The effects of forearm selective cutaneous anesthesia combined with active sensory re-education on sensory motor function of upper limb in chronic stroke survivors: a prelimi
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with cortical ischemic stroke limited to the middle cerebral artery based on brain imaging
more than 6 months have passed since the stroke
patients have an age range of 20 to 65 years
a normal level of consciousness based on answering questions and performing actions requested of the patient
ability to understand one-step instructions and recognize geometric spatial shapes
have a light touch sensation in the fingertips
have a level of 4 or higher on the Brannstrom assessment criteria in the hand
able to transfer one block of the box and block test
have spasticity severity within +1 based on the modified Ashworth criteria
Exclusion criteria:
Having cognitive and visual impairments
neurological surgeries and other neurological diseases
neglect in right hemisphere lesions
having impaired sense of touch in the hands and fingers
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
5
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
This study examines the combination of two sensory re-learning interventions along with a temporary local anesthesia method in the forearm for patients with chronic stroke.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of health and paramedical sciences
Street address
Occupational Therapy Department, Faculty of Rehabilitation and Paramedical sciences, Kharazmi building, sciences Blvd, Ferdowsi university campus, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948964
Approval date
2025-04-26, 1404/02/06
Ethics committee reference number
IR.MUMS.FHMPM.REC.1404.039
Health conditions studied
1
Description of health condition studied
CHRONIC STROKE
ICD-10 code
I63.01
ICD-10 code description
Cerebral infarction due to thrombosis of vertebral artery
Primary outcomes
1
Description
fugl meyer upper extremity sensory motor function assessment
Timepoint
before intervention and 6,12 weeks after intervention
Method of measurement
fugl meyer assessment of sensory-motor function
Secondary outcomes
1
Description
Light touch to deep pressure threshold score with monofilament
Timepoint
before intervention and 6 ،12 weeks after intervention
Method of measurement
semmes-weinstein monofilaments
Intervention groups
1
Description
Intervention group: Half an hour before the start of sensory interventions, the patient's affected forearm is smeared with lidocaine ointment and a bandage is applied to numb the forearm. Then, graded sensory retraining exercises, including localization and stregenosis, are performed in therapy sessions, and at the end of the twelfth session, the results are evaluated and recorded.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Hashemi Nejad hospital and Ghaem hospital
Full name of responsible person
Amin Mahdizadeh
Street address
Hashemi Nejad Hospital, end of Vahid Street, Mashhad, Ahmad Abad Blvd., Ghaem hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١۵۵٧٨٨٨۶٩،9199-9917
Phone
+98 51 3840 0001
Email
aminmahdizadeh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
vise chancellor for research and innovation, Ghomeshi building, Daneshgar street, Mashhad
City
mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
vcresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
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
Mashhad University of Medical Sciences
Full name of responsible person
Amin Mahdizadeh
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
No 52,shahid purebrahim 2,shahid mohammadi 10,ghasem abad
City
Mashhad
Province
Razavi Khorasan
Postal code
1985713874
Phone
+98 51 3658 0251
Fax
Email
MahdizadehA@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Amin Mahdizadeh
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
No 52,shahid purebrahim 2,shahid mohammadi 10,ghasem abad
City
Mashhad
Province
Razavi Khorasan
Postal code
1985713874
Phone
+98 51 3658 0251
Fax
Email
MahdizadehA@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Amin Mahdizadeh
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
No 52,shahid purebrahim 2,shahid mohammadi 10,ghasem abad
City
Mashhad
Province
Razavi Khorasan
Postal code
1985713874
Phone
+98 51 3658 0251
Fax
Email
MahdizadehA@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
the data will be presented after reasonable request
When the data will become available and for how long
After writing article and Data gathering process
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
For metanalysis article
From where data/document is obtainable
via contacting with corresponding author
What processes are involved for a request to access data/document