The effect of ankle foot orthosis tuning using wedges on lower limb joint coordination, gait kinematics and Shank-to-Vertical Angle in stroke individuals
Determining the effect of changing the heel height of the Ankle Foot orthosis on the coordination of lower limb joints, gait kinematics, and the Shank to vertical angle
Design
This study is a single-grouped interventional study on 25 stroke patient
Settings and conduct
This study will be conducted in the Motion Analysis Laboratory of the School of Rehabilitation Sciences, Iran University of Medical Sciences, on patients with chronic stroke. A custom-made orthosis will be fabricated and fitted for each participant, and the 2-minute walk test and Timed Up and Go test will be performed under different heel heights (0–25 mm in 5-mm increments) in randomized order. Kinematic gait data will be recorded using the Qualisys Motion Capture system and analyzed by an assessor blinded to the heel height condition through coded labeling.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
• Ischemic stroke (≥ 6 months post-stroke)
• Ability to walk independently
• Age 40–66 years
• Ankle spasticity ≤ 2 (Modified Ashworth Scale)
• FAC ≥ 4
Exclusion Criteria:
Use of medication and presence of any disease or structural condition affecting gait.
Intervention groups
In this study, individual with stroke will receive an ankle foot orthosis with heel height adjusted between 0 and 2.5 cm, and its effects on gait kinematics and lower limb motor coordination will be evaluated.
Main outcome variables
Kinematic parameters of lower limb joints, Shank to vertical angle, leg-thigh coordination pattern, TUG and 2MWT walk test
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20260131068709N1
Registration date:2026-05-30, 1405/03/09
Registration timing:retrospective
Last update:2026-05-30, 1405/03/09
Update count:0
Registration date
2026-05-30, 1405/03/09
Registrant information
Name
Mahtab Bagheri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 912 602 2226
Email address
mahtabbagheri140@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-22, 1403/05/01
Expected recruitment end date
2026-04-21, 1405/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of ankle foot orthosis tuning using wedges on lower limb joint coordination, gait kinematics and Shank-to-Vertical Angle in stroke individuals
Public title
Analyzing the effect of Ankle Foot orthosis adjustment on gait of stroke patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of ischemic hemiplegic stroke
At least 6 months have elapsed since the onset of stroke
Ability to stand and walk independently without assistance or the use of a cane
Modified Ashworth Scale score of 2 or less at the ankle joint
Age between 40 and 66 years
History of only one stroke episode
Motor function of the lower extremities at Brunnstrom recovery stage 5 or higher
Motor function of the upper extremities at Brunnstrom recovery stage 4 or higher
Walking ability based on the Functional Ambulation Category (FAC) score of 4 or higher
Exclusion criteria:
Use of medications that may interfere with walking and balance.
Structural limb length discrepancy between the lower extremitie
Uncontrolled diabetes mellitus or uncontrolled hypertension
Uncorrected visual or hearing impairments
Bilateral involvement resulting from stroke
Presence of any neuromuscular or neurological disorders, such as Parkinson’s disease, cerebellar disorders, or vestibular disorders
Presence of cognitive impairment
Unilateral neglect
Age
From 40 years old to 66 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
25
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
Research Ethics Working Group/Committee, Iran University of Medical Sciences
Street address
Hemmat Highway, next to Milad Tower, Iran University of Medical Sciences, Central Headquarters Building, Vice President for Research and Technology
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2024-04-22, 1403/02/03
Ethics committee reference number
IR.IUMS.REC.1403.064
Health conditions studied
1
Description of health condition studied
stroke
ICD-10 code
164
ICD-10 code description
Stroke, not specified as haemorrhage or infarction
Primary outcomes
1
Description
primary outcome:Intra-limb coordination pattern between the thigh and shank during gait without an ankle-foot orthosis and under seven heel height conditions of the ankle-foot orthosis in individuals with hemiparetic stroke (instantaneous measurements).
Timepoint
Outcome measurements will be conducted in a single session and performed immediately. Assessment under each study condition (different orthotic conditions) will be carried out immediately after applying the respective condition.
Method of measurement
In this study, a Qualisys Motion Capture (QMC) motion capture analyzer with five cameras will be used to calculate joint kinematics, shank to vertical angle, and the Thigh-Shank segment coordination pattern.
Secondary outcomes
1
Description
Time to complete the Time Up and Go (TUG) test without an ankle-foot orthosis and under seven ankle-foot orthosis heel-height conditions in individuals with hemiplegic stroke (measured immediately).
Timepoint
Outcome measurements will be conducted in a single session and performed immediately. Assessment under each study condition (different orthotic conditions) will be carried out immediately after applying the respective condition.
Method of measurement
Time Up and Go test: Total time from the command to rise from the chair, walk 3 meters, turn 180°, return, and sit back down until full buttock contact with the chair is measured using a stopwatch (in seconds).
2
Description
Distance covered during the 2-Minute Walk Test without an ankle-foot orthosis and under seven ankle-foot orthosis heel-height conditions in individuals with hemiplegic stroke (measured immediately).
Timepoint
The aforementioned study outcome will be measured in a single session and in real time. Evaluation under each investigated condition (different orthotic conditions) will be performed immediately after applying that specific condition.
Method of measurement
2-Minute Walk test: Distance covered over the entire 2-minute interval is measured using a stopwatch, from the start signal until exactly 2 minutes have elapsed.
3
Description
Shank-to-vertical angle during walking without an ankle-foot orthosis and under seven ankle-foot orthosis heel-height conditions in individuals with hemiplegic stroke (measured immediately).
Timepoint
The aforementioned study outcome will be measured in a single session and in real time. Evaluation under each investigated condition (different orthotic conditions) will be performed immediately after applying that specific condition.
Method of measurement
Shank-to-vertical angle: Angle relative to the vertical axis during stance phase, specifically at mid-stance, measured using reflective markers on the shank and 3D motion analysis system.
Intervention groups
1
Description
Intervention group: In order to make an Solid ankle-foot orthosis, a mold will be taken of the affected foot in a semi-weight-bearing position. The Solid ankle-foot orthosis is custom-made with the following features: 5 mm propylene sheet, 90-degree angle at the ankle, one centimeter cut line in front of the ankles, and two Velcro straps added horizontally to the proximal orthosis and opposite the ankles at a 45-degree angle. In each condition, heel heights are adjusted from 0 to 25 mm. There are a total of 7 assessment positions.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Occupational Therapy and Physiotherapy Clinic, Faculty of Rehabilitation Sciences, Iran University o
Full name of responsible person
Ghorban Taghizadeh
Street address
Tehran, Mirdamad, Madar Square, Shah Nazari Street, Madakaran Street, Faculty of Rehabilitation Sciences, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1545987134
Phone
+98 21 2222 8051
Fax
Email
taghizadeh.gh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Deputy for research
Street address
Faculty of Rehabilitation Sciences, Iran University, Madakaran St, Mirdamad Blvd
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 8051
Fax
Email
mehraban.a@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
20
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
Iran University of Medical Sciences
Full name of responsible person
Mahtab Bagheri
Position
PhD Candidate
Latest degree
Master
Other areas of specialty/work
orthosis and prosthesis
Street address
No10,Tadayyon Alley, Shariati Avenue
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2272 6458
Fax
Email
mahtabbagheri140@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sanjari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Biomechanic
Street address
Faculty of Rehabilitation Sciences, Iran University of Medical Sciences, Shah Nazari Street, Mirdamad, Madar Square,
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 8051
Fax
Email
sanjarima@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mahtab Bagheri
Position
PhD Candidate
Latest degree
Master
Other areas of specialty/work
Orthosis and Prosthesis
Street address
No 10, Tadayyon Alley, Shariati St
City
Tehran
Province
Tehran
Postal code
1666658176
Phone
+98 21 2272 6458
Email
mahtabbagheri140@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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