Comparison of The effect of Pan Splint and Extention Splint with Tendon Pressure Points on Hand and Wrist Flexors Spasticity and increased range of motion in Patients with Stroke
Comparison of The effect of Pan Splint and Extention Splint with Tendon Pressure Points on Hand and Wrist Flexors Spasticity and increased range of motion in Patients with Stroke
Design
parallel group trial with blinded outcome assessment, Blocked Randomization
Settings and conduct
This study was designed to investigate the effect of two types of splints on spasticity and range of motion in stroke patients. The study is a randomized clinical trial. After referring the patient to the neurology clinic of Hamadan University of Medical Sciences and signing a written consent from the patient or his companion, for each patient information about age, sex, weight, height, time elapsed from the onset of the disease and the affected side of The interview and examination are recorded in the file. We use the blocked method to randomize. The assessments are made by a specialist at the beginning of the visit and are presented to the Technical Orthopedic Center of the Comprehensive Rehabilitation Center of the Rehabilitation Center affiliated to the School of Rehabilitation. And re-evaluated. We will consider this basic information as a control group. The patient will use the relevant splint for 4 weeks and for 8 hours a day, and at the end of 4 weeks he will see the relevant doctor again for re-evaluation. The patient is unaware of the type of splint received.
Participants/Inclusion and exclusion criteria
1. Age between 40-70
2. At least 2 months, up to 5 years disease duration.
3. Wrist and hands flexors MMAS score≥ 1
4. First-ever stroke
5. No cognition impairment
6.No taking antispastic drugs
7. Excluded diabetic patient
8.Excluded any other neurological disorders
Intervention groups
Pan Splint Group
Extention Splint with Tendon Pressure Points Group
Main outcome variables
Modified Modified Ashworth Scale
Passive Range of Motion
Active Range of Motion
Fugl Mayer functional Scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200531047610N1
Registration date:2020-06-27, 1399/04/07
Registration timing:registered_while_recruiting
Last update:2020-06-27, 1399/04/07
Update count:0
Registration date
2020-06-27, 1399/04/07
Registrant information
Name
Omid Torkaman
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3827 2846
Email address
o.torkaman@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-25, 1399/04/05
Expected recruitment end date
2020-10-26, 1399/08/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of The effect of Pan Splint and Extention Splint with Tendon Pressure Points on Hand and Wrist Flexors Spasticity and increased range of motion in Patients with Stroke
Public title
effect of splint on hand spasticity
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
At least two months from last lesion time
intensity of wrist and hand spasity MMAS ≥ 1
The first patient to stroke
Be able to understand the commands
Exclusion criteria:
Taking an anti spasticity drug
There are other neurologic disease
Of diabetes
contracture more dan ten degrees
Age
From 40 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National Ethics Committee in Biomedical Research
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Blvd., Hamadan
City
Hamadan
Province
Hamadan
Postal code
6517838736
Approval date
2020-06-09, 1399/03/20
Ethics committee reference number
IR.UMSHA.REC.1399.047
Health conditions studied
1
Description of health condition studied
Sequelae of stroke
ICD-10 code
I69.4
ICD-10 code description
Sequelae of stroke, not specified as haemorrhage or infarction
Primary outcomes
1
Description
Spasticity
Timepoint
Before After
Method of measurement
Modified Modified Ashworth Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Pan splint
Category
Rehabilitation
2
Description
Intervention group: Extension Splint with pressure points
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Mobasher Rehabilitation Clinic
Full name of responsible person
Omid Torkaman
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Blvd, Hamadan
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 1571
Email
otorkaman@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Blvd. Hamadan
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 1571
Email
otorkaman@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Omid Torkaman
Position
lecturer
Latest degree
Master
Other areas of specialty/work
Others
Street address
Hamadan University of Medical Sciences, Shahid Fahmide Blv, Hamadan
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 1571
Email
otorkaman@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Omid Torkaman
Position
lecturer
Latest degree
Master
Other areas of specialty/work
Others
Street address
Hamadan University of Medical Sciences, Shahid Fahmide Blv, Hamadan
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 1571
Email
otorkaman@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Omid Torkaman
Position
lecturer
Latest degree
Master
Other areas of specialty/work
Others
Street address
Hamadan University of Medical Sciences, Shahid Fahmide Blv, Hamadan
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 1571
Email
otorkaman@yahoo.com
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