The Effect of 6-Week Use of the newly designed anti-spasticity Orthosis on Spasticity, Muscle Function, and Quality of Life in Patients with Stroke and Multiple Sclerosis
To determine the effect of 6 weeks of using a new anti-spasticity orthosis on the level of spasticity, muscle function, and quality of life in patients with stroke and multiple sclerosis
Design
A single-group clinical trial (without control group) designed as a before-and-after comparison of affected side with itself, on 13 patients where blinding is not possible, but the order of measuring outcomes will be randomized.
Settings and conduct
Patients with unilateral spastic hand resulting from multiple sclerosis or stroke who are residents of Qazvin will participate in this study. This research will be conducted to determine the effect of six weeks of using the intervention (a new anti-spastic orthosis) on the parameters of the affected side. For this purpose, an orthosis will be delivered to each individual and the method of use will be taught. Data, which are obtained from the clinical assessment of the involved limb, will be compared before and after using the orthosis. Blinding is impossible for any of the participants or the researcher. The study will take place in Qazvin.
Participants/Inclusion and exclusion criteria
Eligible participants will be adults aged 18 to 65 with a confirmed history of stroke or multiple sclerosis (onset at least 6 months prior), presenting with mild to moderate spasticity per the Modified Ashworth Scale, and demonstrating the ability to comprehend and cooperate. Individuals will be excluded if they have severe upper limb orthopedic conditions, open skin wounds at the proposed orthosis site, or are concurrently using other similar therapeutic devices.
Intervention groups
A self-controlled study examines the 6-week effects of an anti-spastic orthosis on spasticity level in multiple sclerosis/ stroke patients with hemiplegia, without a control group
Main outcome variables
modified Ashworth Scale; muscle strength; quality of life; time of orthosis use
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230528058315N4
Registration date:2025-12-02, 1404/09/11
Registration timing:registered_while_recruiting
Last update:2025-12-02, 1404/09/11
Update count:0
Registration date
2025-12-02, 1404/09/11
Registrant information
Name
Nahid Tafti
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 1633
Email address
n.tafti@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-12-01, 1404/09/10
Expected recruitment end date
2026-10-23, 1405/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of 6-Week Use of the newly designed anti-spasticity Orthosis on Spasticity, Muscle Function, and Quality of Life in Patients with Stroke and Multiple Sclerosis
Public title
Efficacy of a Novel Anti-spasticity Orthosis on Spasticity, Muscle Function, and Quality of Life
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The presence of mild to moderate spasticity (according to the Modified Ashworth Scale)
A history of stroke or multiple sclerosis at least 6 months prior to the study onset
Ability to comprehend and cooperate
Exclusion criteria:
Presence of severe orthopedic conditions in the upper limb
open skin wounds at the orthosis site
concurrent use of other similar therapeutic devices
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
13
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamadan University of Medical Sciences
Street address
Shahid Fahmideh
City
Hamadan
Province
Hamadan
Postal code
6517838840
Approval date
2025-11-05, 1404/08/14
Ethics committee reference number
IR.UMSHA.REC.1404.672
Health conditions studied
1
Description of health condition studied
multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
2
Description of health condition studied
hemiplegia
ICD-10 code
G83.8
ICD-10 code description
Other specified paralytic syndromes
Primary outcomes
1
Description
spasm severity
Timepoint
At baseline and after six-week use of anti-spastic orthosis
Method of measurement
Modified Ashworth scale
2
Description
Quality of life
Timepoint
At baseline and after six-week use of anti-spastic orthosis
Method of measurement
the score of EQ-5D-3L questionnaire
3
Description
Muscle strength
Timepoint
At baseline and after six-week use of anti-spastic orthosis
Method of measurement
manual muscle testing
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Each participant will be evaluated under two conditions: at baseline without history of using an antispastic orthosis, and after six-week using the new antispastic orthosis on the affected side, with the evaluation order randomized and a 5-minute rest period between outcome measures. Spasticity evaluation will involve use of the modified Ashworth scale, while the EQ-5D-3L will be used to assess quality of life and the muscle strength will be measured by manual muscle testing, , all conducted at the Bu Ali hospital in Qazvin. There is no control group
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Bu Ali Sina Hospital
Full name of responsible person
Narges Zeynali
Street address
Bu Ali Sina Hospital, west Bu Ali Street
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3335 2653
Email
nzeynali2019@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Alireza Soltanian
Street address
Shahid Fahmideh
City
Hamadan
Province
Hamadan
Postal code
6517838840
Phone
+98 81 3131 4058
Email
Info.research@umsha.ac.ir
Web page address
https://research.umsha.ac.ir/
Grant name
Vice President for Research and Technology, Hamadan University of Medical Sciences
Grant code / Reference number
48304
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
Nahid Tafti
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Rehabilitation management
Street address
Shahid Fahmideh
City
Hamadan
Province
Hamadan
Postal code
6517838840
Phone
+98 81 3838 1571
Email
Na.Tafti@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Narges Zeynali
Position
B.Sc. Student
Latest degree
Bachelor
Other areas of specialty/work
Rehabilitation management
Street address
Shahid Fahmideh
City
Hamadan
Province
Hamadan
Postal code
6517838840
Phone
+98 81 3838 1571
Email
nzeynali2019@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Narges Zeynali
Position
B.Sc Student
Latest degree
Bachelor
Other areas of specialty/work
Rehabilitation management
Street address
26 Shir-o-Khorshid Alley, No. 21, Ground Floor
City
Qazvin
Province
Qazvin
Postal code
3413775461
Phone
+98 28 3333 5297
Email
nzeynali2019@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