Evaluation of the immediate effect of the novel spring-damper ankle-foot orthosis on margin of stability of affected and unaffected limbs during walking of patients diseased to multiple sclerosis with drop foot
Study of the immediate effect of a new spring-damper ankle-foot orthosis on the stability range of the healthy and affected limbs during walking in patients with multiple sclerosis and unilateral foot drop
Design
A single-group clinical trial (without control group) designed as a before-and-after comparison of affected and non-affected sides with itself, on 12 patients where blinding is not possible, but the order of data collection for the orthosis-wearing and shoe-only conditions will be randomized.
Settings and conduct
Patients with unilateral foot drop due to multiple sclerosis and residing in Tehran will participate in this study. The research will be conducted to determine the immediate effect of using the intervention (new articulated orthosis) on the affected side on the parameters of both the healthy and affected sides, and for this purpose, gait data with the orthosis and without the orthosis will be compared. The nature of the use of the orthosis and data collection makes it impossible to blind the data collection for any of the volunteers and the researcher. Data collection will be conducted in Tehran.
Participants/Inclusion and exclusion criteria
Diagnosed with multiple sclerosis; unilateral foot drop; has the ability to walk independently without a cane
Intervention groups
A self-controlled study examines the immediate effects of a spring-damper orthosis on both legs in multiple sclerosis patients with unilateral foot drop, without a control group
Main outcome variables
Age; Gender; Height; Weight; Berg Balance Scale score; Heel contact stability range in anterior-posterior direction; Heel contact stability range in medial-lateral direction; Mid-stance stability range in anterior-posterior direction; Mid-stance stability range in medial-lateral direction; Step length; Step width; Expanded Disability Status Scale (EDSS) score; Spasticity level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230528058315N3
Registration date:2025-08-12, 1404/05/21
Registration timing:prospective
Last update:2025-08-12, 1404/05/21
Update count:0
Registration date
2025-08-12, 1404/05/21
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
2025-09-23, 1404/07/01
Expected recruitment end date
2026-02-20, 1404/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the immediate effect of the novel spring-damper ankle-foot orthosis on margin of stability of affected and unaffected limbs during walking of patients diseased to multiple sclerosis with drop foot
Public title
The immediate effect of the novel spring-damper ankle-foot orthosis on margin of stability of affected and unaffected limbs during walking of patients diseased to MS
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Adults with unilateral foot drop caused by multiple sclerosis
Ability to walk at least 25 steps without assistance
Ability to complete at least 25 steps within a duration of 8 to 45 seconds
Maximum grade of 3- (minus) in the manual muscle strength test for dorsiflexors and grade 3+ (plus) in knee extensor muscles
Ability to walk without orthoses for up to ten meters
Ability to achieve at least 5 degrees of passive dorsiflexion
Completion of the Four Square Step Test (FSST) in less than 15 seconds
Exclusion criteria:
Having cardiovascular or respiratory problems
Presence of limb impairment or amputation on the opposite side
Concurrent use of other treatment methods (e.g., physiotherapy or surgery) during the study
Having perceptual-cognitive impairments
Presence of polyneuropathy
Instability and imbalance while standing or walking
Severe visual or hearing impairment
History of spinal fracture or pain
Participant's unwillingness to continue cooperation
Absence of spasticity greater than grade 3 in the plantar flexor muscles (according to the Ashworth scale)
scoring less than 5 on the disability scale
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
12
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
2025-07-26, 1404/05/04
Ethics committee reference number
IR.UMSHA.REC.1404.315
Health conditions studied
1
Description of health condition studied
Multiple Sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
Margin of stability
Timepoint
After 5 minutes adaptation with orthosis
Method of measurement
Viacon motion analysis system and Kistler force plate
Secondary outcomes
1
Description
Stride length
Timepoint
Immediately after receiving the orthosis
Method of measurement
Viacon Motion Analysis System
2
Description
Stride width
Timepoint
Immediately after receiving the orthosis
Method of measurement
Viacon Motion Analysis System
Intervention groups
1
Description
Intervention group: Each participant will be evaluated under two conditions: wearing shoes on both sides, and wearing a shoe on the unaffected side along with the new spring-damper orthosis on the affected side, with the evaluation order randomized and a 5-minute rest period between conditions. Kinematic assessment will involve evaluating center of mass (COM) displacement velocity by tracking a sacral marker using a Vicon motion analysis system equipped with six infrared cameras recording at 120 Hz, while two Kistler force plates sampling at 1200 Hz will be used to assess plantar center of pressure (COP) and COM, with synchronized data collection from both the motion capture system and force plates, all conducted at the Mofaghian Research Center in Tehran. There is no control group.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Occupational Therapy Clinic, Faculty of Rehabilitation Sciences, University of Iran, Tehran
Full name of responsible person
Nahid Tafti
Street address
Faculty of Rehabilitation Sciences, Madadkaran Street, Shah Nazari Street, Mother Square, Mirdamad,
City
Tehran
Province
Tehran
Postal code
۱۳۴۸۷۱۵۴۵۹
Phone
+98 936 264 2025
Email
Na.Tafti@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 Blvd
City
Hamadan
Province
Hamadan
Postal code
6517838678
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
۴۶۵۲۴
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
Ensieh Pourhoseingholi
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
ensihphd@gmail.com
Person responsible for scientific 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 updating data
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
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