IRCT | Investigating the immediate effect and overall efficacy of a new hybrid passive spring-damper ankle-foot orthosis compared to a traditional solid ankle-foot orthosis on the dynamic stability of both involved and non-involved sides in hemiplegic individuals with foot drop due to cerebral palsy after 6 weeks of use

Protocol summary

Study aim: Investigating the immediate effect and overall efficacy of a new hybrid passive spring-damper ankle-foot orthosis compared to a traditional solid ankle-foot orthosis on the dynamic stability of both involved and non-involved sides in hemiplegic individuals with foot drop due to cerebral palsy after 6 weeks of use
Design: Phase III randomized, parallel group, double-blind trial with a sample size of 24 people
Settings and conduct: In the Biomechanics Laboratory of the Javad Mofavaghian Neurological Rehabilitation Center, patients were non-randomly divided into two groups of 12, each receiving a type of orthosis: a solid ankle orthosis and a damper spring. Kinetic and kinematic data were measured using a Kistler force plate and 6 Vicon infrared cameras, and parameters related to dynamic stability were obtained from these data using mathematical calculations in Matlab software.
Participants/Inclusion and exclusion criteria: Participants were adults aged 18 to 55 years who used a Solid ankle-foot orthosis daily. They had to be free of significant disabling limitations or contractures in the contralateral or ipsilateral joints, able to walk independently with or without the use of an ankle orthosis, have a functional assessment score of 1 to 2, and be able to perform at least 5 degrees of active or passive dorsiflexion.
Intervention groups: Using two types of ankle foot orthoses: solid and spring damper
Main outcome variables: Postural stability

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20190919044818N6

Registration date: 2025-09-07, 1404/06/16

Registration timing: prospective

Last update: 2025-09-07, 1404/06/16

Update count: 0
Registration date: 2025-09-07, 1404/06/16

Registrant information: Name

Ensieh Pourhosaingholi

Name of organization / entity

Country

Iran (Islamic Republic of)

Phone

+98 21 4480 3255

Email address

ensiehpmd@yahoo.com

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2025-10-23, 1404/08/01
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: Investigating the immediate effect and overall efficacy of a new hybrid passive spring-damper ankle-foot orthosis compared to a traditional solid ankle-foot orthosis on the dynamic stability of both involved and non-involved sides in hemiplegic individuals with foot drop due to cerebral palsy after 6 weeks of use

Public title: Investigation of the immediate effect and overall efficacy of a new passive hybrid spring-damper ankle-foot orthosis for dynamic stability
Purpose: Treatment
Inclusion/Exclusion criteria: Inclusion criteria:

Adults between 18 and 55 years old Daily use of Solid ankle-foot orthosis Ability to walk independently with or without the use of an ankle foot orthosis Gross motor function measurement scale between 1 and 2 Ashworth scale between 1 and 3 Ability to perform at least 5 degrees of active or passive dorsiflexion

Exclusion criteria:

The presence of cognitive problems that prevent understanding the researcher's instructions. Botulism toxin injection in the last 9 months Having vision or hearing problems Marked disabling limitation or contracture in the joints of the opposite limb or higher joints on the same side
Age: From 18 years old to 55 years old
Gender: Both

Phase

N/A

Groups that have been masked

Participant
Outcome assessor
Data analyser

Sample size

Target sample size: 24

Randomization (investigator's opinion)

Randomized

Randomization description

Participants were assigned to groups using both sequential and block randomization methods, based on a computer-generated random number list. An independent researcher utilized statistical software to randomly allocate subjects into experimental and control groups. The allocation was done in a 1:1 ratio using random blocks of size two. The allocation sequence was kept hidden from the researcher responsible for registration and evaluation, and participants were numbered in order.

Blinding (investigator's opinion)

Double blinded

Blinding description

Participants, outcome assessors, and data analysts are unaware of the study group assignments.

Placebo

Not used

Assignment

Parallel

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

Hamadan, Shahid Fahmideh Blvd., Hamadan University of Medical Sciences, Faculty of Rehabilitation, Orthotics and Prosthetics Department

City

همدان

Province

Hamadan

Postal code

۶۵۱۷۸۳۸۷۳۶
Approval date: 2025-07-26, 1404/05/04
Ethics committee reference number: IR.UMSHA.REC.1404.270

Health conditions studied

1

Description of health condition studied: Cerebral palsy
ICD-10 code: G80
ICD-10 code description: Cerebral palsy

Primary outcomes

1

Description: Dynamic stability
Timepoint: Before intervention, immediately after the study, 6 weeks after intervention
Method of measurement: Using a Force plate and 6 ultraviolet camera

Secondary outcomes

1

Description: Postural stability
Timepoint: 4 month
Method of measurement: Vicon infrared camera, Kistler force plate

Intervention groups

1

Description: Intervention group: The treatment protocol involved utilizing a researcher-solid ankle foot orthosis model. During the intervention, detailed kinetic and kinematic gait analyses were conducted using the Vicon MX-40 infrared camera system (UK-made) alongside the Kistler 9286AA force plate (manufactured in the USA) to precisely capture patient movement patterns. Each patient underwent a one-hour testing session, split into two appointments spaced six weeks apart. At the start of each session, patients were given a 10-minute orientation to familiarize themselves with the laboratory setting and to receive instructions on the testing procedures.
Category: Rehabilitation

2

Description: Intervention group: The treatment protocol involved utilizing a researcher-developed spring damper ankle foot orthosis model. During the intervention, detailed kinetic and kinematic gait analyses were conducted using the Vicon MX-40 infrared camera system (UK-made) alongside the Kistler 9286AA force plate (manufactured in the USA) to precisely capture patient movement patterns. Each patient underwent a one-hour testing session, split into two appointments spaced six weeks apart. At the start of each session, patients were given a 10-minute orientation to familiarize themselves with the laboratory setting and to receive instructions on the testing procedures.
Category: Rehabilitation

Recruitment centers

1

Recruitment center: Name of recruitment center

Occupational Therapy Clinic, Iran University of Medical Sciences

Full name of responsible person

Ensieh Pourhoseingholi

Street address

Orthotics and Prosthetics Department, Faculty of Rehabilitation, Hamadan University of Medical Sciences, Shahid Fahmideh Blvd., Hamedan, Iran

City

Hamadan

Province

Hamadan

Postal code

۶۵۱۷۸۳۸۷۳۶

Phone

+98 21 4480 3255

Email

ensiehpmd@yahoo.com

1

Sponsor: Name of organization / entity

Hamedan University of Medical Sciences

Full name of responsible person

Alireza Soltanian

Street address

Vice chancellery for research and technology, Hamadan University of Medical Sciences, Shahid Fahmideh Blvd., Hamedan, Iran

City

Hamadan

Province

Hamadan

Postal code

۶۵۱۷۸۳۸۷۳۶

Phone

+98 81 3131 0000

Email

alireza.soltanian@umsha.ac.ir
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

Ensieh Pourhoseingholi

Position

Assistant Professor

Latest degree

Ph.D.

Other areas of specialty/work

Others

Street address

Orthotics and Prosthetics Department, Faculty of Rehabilitation, Hamadan University of Medical Sciences, Shahid Fahmideh Blvd., Hamedan, Iran

City

Hamadan

Province

Hamadan

Postal code

۶۵۱۷۸۳۸۷۳۶

Phone

+98 21 4480 3255

Email

ensiehpmd@yahoo.com

Person responsible for scientific 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

Others

Street address

Orthotics and Prosthetics Department, Faculty of Rehabilitation, Hamadan University of Medical Sciences, Shahid Fahmideh Blvd., Hamedan, Iran

City

Hamadan

Province

Hamadan

Postal code

۶۵۱۷۸۳۸۷۳۶

Phone

+98 21 4480 3255

Email

ensiehpmd@yahoo.com

Person responsible for updating data

Contact: Name of organization / entity

Hamedan University of Medical Sciences

Full name of responsible person

Ensieh Pourhoseingho

Position

Assistant Professor

Latest degree

Ph.D.

Other areas of specialty/work

Others

Street address

Orthotics and Prosthetics Department, Faculty of Rehabilitation, Hamadan University of Medical Sciences, Shahid Fahmideh Blvd., Hamedan, Iran

City

Hamadan

Province

Hamadan

Postal code

۶۵۱۷۸۳۸۷۳۶

Phone

+98 21 4480 3255

Email

ensiehpmd@yahoo.com

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: No - There is not a plan to make this available
Data Dictionary: Not applicable
Title and more details about the data/document: Parameters related to dynamic stability include the speed and direction of movement of the center of pressure and the center of mass of the body.
When the data will become available and for how long: Immediately after sampling in 1404
To whom data/document is available: Researchers
Under which criteria data/document could be used: Conducting more research in the field of health
From where data/document is obtainable: Ensieh Pourhoseingholi, Faculty of Rehabilitation, Hamadan University of Medical Sciences
What processes are involved for a request to access data/document: Immediately after the article is published and via email
Comments