Immediate and after 6 weeks effect of newly design articulated Ankle Foot Orthosis on postural control in static and dynamic conditions in drop foot post stroke

Comparison of the effect of newly designed articulated ankle-foot orthosis and posterior leaf spring on postural control and COP in static and dynamic conditions in stroke patients.

A single-blind, quasi-experimental, parallel group trial with repeated measures on 20 stroke patients

This is a single-blind quasi-experimental study with repeated measures on 20 hemiplegic stroke patients (with drop foot). Simple non-probability sampling will be performed from patients referred to orthotics clinics in Tehran. Eligible participants will be randomly assigned to two parallel groups (newly designed articulated AFO and posterior leaf spring AFO). Location: Biomechanics Research Center of Sharif University of Technology (Kistler force plate). Procedure: Assessments will be conducted in two stages (immediately after receiving the orthosis and after 6 weeks of continuous use) under four conditions (hard/foam surface with eyes open/closed). The outcome assessor and statistical analyst will be blinded.

inclusion criteria : age 40 and 65 years, dorsiflexion weakness, spasticity max grade 1, at least 6 months post-stroke, ability to walk independently, and daily use of PLS. Exclusion criteria: history of cardiovascular and pulmonary diseases, joint contracture, knee hyperflexion, hammer toes, severe visual impairment, and poor balance.

Participants will be assigned to two equal parallel groups: Group 1: Using a standard ankle-foot orthosis (posterior leaf spring) for 6 weeks. Group 2: Using a newly designed articulated ankle-foot orthosis for 6 weeks. Data from the condition before using the orthosis (wearing shoes only) will be considered as the control condition.

1. COP sway in AP and ML directions 2. Mean COP velocity 3. Path length 4. Ellipse area

In this study, participants will be randomly assigned to two equal groups using a simple lottery method. One group will receive the standard intervention (posterior leaf spring AFO) and the other group will receive the newly designed articulated AFO for a period of 6 weeks.

This study utilizes a single-blind design. Due to the visual and physical nature of the ankle-foot orthoses and the type of intervention, blinding of the participants and the healthcare providers (the orthotist fitting the device) is not possible. However, the outcome assessor (the individual recording and extracting force plate data) will be blinded to the group allocation and the type of intervention. Additionally, the data collectors and the statistical analyst will be blinded to the group codes to minimize bias. Data will also be monitored by a Data Safety and Monitoring Committee."

Full study protocol, informed consent form, and raw data related to Center of Pressure (COP) parameters, which will be anonymized.

Access to the protocol and informed consent form will be available upon registration in the IRCT. Access to raw data and final results will be provided 6 months after the study completion and article publication

Academic researchers and scientific-research institutions who submit a written request and obtain approval from the Ethics Committee for scientific use of the data.

Solely for research and scientific purposes, with proper citation, and without any commercial use. Data usage is contingent upon maintaining the confidentiality of participants' information.

Requestors can contact the principal investigator, Ms. Zahra Soltani Hanafipour, via email (nesa.soltani.hp@gmail.com) to obtain the data or documents. They may also refer to the address of the Vice Chancellor for Research and Technology of Hamadan University of Medical Sciences.

The request process includes the following steps: 1. Sending a written request to the principal investigator via email. 2. Review of the request by the research team and approval by the Ethics Committee. 3. Signing a Confidentiality Agreement by the requestor. 4. Sending anonymized data via secure email. This process typically takes a maximum of one month.