Anterior Foot Wedge With Neuromuscular Training for Balance in Parkinson's Disease (AFW-NT)

Efficacy of Anterior Foot Wedge Modulation With Neuromuscular Training on Balance During Walking in Parkinsonian Patients

This study will test whether combining an anterior foot wedge with neuromuscular training can improve balance, gait, and muscle activity in people with Parkinson's disease. Thirty patients (ages 45-75) with moderate Parkinson's (Hoehn & Yahr Stage III) will be randomly assigned to one of two groups:

Group 1 (Control): Receives a standard physical therapy program including stretching, strengthening, PNF, weight-shifting, and gait training.

Group 2 (Experimental): Receives the same physical therapy plus neuromuscular training using the Biodex Multi-Joint System and a custom anterior foot wedge.

All participants will train for 60 minutes, three times per week, for 8 weeks. Before and after the program, researchers will measure: balance (using the Biodex Balance System), gait (via Unified Parkinson's Disease Rating Scale and motion analysis), and muscle activity in the trunk (using electromyography). The goal is to find a more effective rehabilitation approach to reduce fall risk and improve walking in Parkinson's patients.

Study Overview

• Status: Not yet recruiting
• Conditions: Parkinson's Disease; Gait Disorder; Postural Instability
• Intervention / Treatment: Device: Anterior foot wedge; Behavioral: Neuromuscular training

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Reda kotb gadelhak; Phone Number: +966532476201; Email: dr_reda_kotb@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosis of Parkinson's disease, confirmed by neurologist. Disease severity classified as Stage III on the Hoehn & Yahr scale. Age between 45 and 75 years. Medically stable (normal vital signs). Conscious, cooperative, and able to follow instructions. No severe cognitive or psychological impairment. Able to provide informed consent.

Exclusion Criteria:

• Severe disability or advanced Parkinsonism (Stage IV or V). Presence of other neurological or orthopedic conditions affecting gait or balance (e.g., stroke, spinal cord injury, severe arthritis).

History of diabetes in second-degree relatives (as specified in your protocol). Unstable medical conditions (e.g., uncontrolled hypertension, cardiac disease). Inability to stand or walk with minimal assistance. Non-cooperative or unable to tolerate assessment procedures (EMG, Biodex, motion analysis).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Neuromuscular Training + Anterior Foot Wedge + Conventional PT; Participants will receive a 60-minute session, 3 times per week for 8 weeks, consisting of: (1) conventional physical therapy including proprioceptive neuromuscular facilitation (PNF) for head, neck, and trunk; stretching of lower limb flexors; strengthening of lower limb extensors and trunk muscles; and balance/weight-shifting exercises; (2) a customized anterior foot wedge worn during all training sessions to modulate center of pressure; and (3) neuromuscular training using the Biodex Multi-Joint System to enhance postural control and gait stability.	Device: Anterior foot wedge; A custom-made orthotic insert placed under the forefoot to shift the center of pressure anteriorly, thereby enhancing postural stability and balance during walking and standing tasks in Parkinsonian patients.; Behavioral: Neuromuscular training; A structured training program using the Biodex Multi-Joint System to improve dynamic balance, motor control, and gait stability through reactive and perturbation-based exercises, performed 3 times per week for 8 weeks.
Active Comparator: Conventional Physical Therapy Only; articipants will receive a 60-minute session, 3 times per week for 8 weeks, consisting of conventional physical therapy including: proprioceptive neuromuscular facilitation (PNF) for head, neck, and trunk; stretching of lower limb flexor muscles; strengthening of lower limb extensor and trunk muscles; balance exercises; and weight-shifting and gait training.	Behavioral: Neuromuscular training; A structured training program using the Biodex Multi-Joint System to improve dynamic balance, motor control, and gait stability through reactive and perturbation-based exercises, performed 3 times per week for 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Limit of Stability (LOS)	Measured using the Biodex Balance System SD (Model BLS003, USA). The Limit of Stability test assesses the patient's ability to voluntarily shift their center of gravity to the maximum distance in eight directions without losing balance. Results are reported as a composite stability index score (lower = better stability).	Baseline and after 8 weeks of intervention (24 sessions)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Gait Disability (UPDRS Score)	Assessed using Part III (Motor Examination) of the Unified Parkinson's Disease Rating Scale (UPDRS), specifically items related to gait, posture, and postural stability. Total score ranges from 0 (no disability) to higher values (greater impairment).	Baseline and after 8 weeks
Change in Step Length	Measured using a 3D motion analysis system (Hocoma, Model 000341, USA). Average step length (distance between successive heel strikes) in centimeters during comfortable walking speed.	Baseline and after 8 weeks
Change in Walking Velocity	Measured via motion analysis system during a 10-meter walk test. Reported in meters per second.	Baseline and after 8 weeks
Change in Cadence	Number of steps per minute during walking, recorded by motion analysis system.	Baseline and after 8 weeks
Change in Electromyographic (EMG) Amplitude of Trunk Muscles	Surface EMG (Neuropac S1, Model DI 90B, Japan) used to record amplitude of motor unit action potentials (in microvolts, µV) from rectus abdominis and erector spinae muscles during standing and walking tasks.	Baseline and after 8 weeks

Collaborators and Investigators

• Sponsor: MTI University

Study record dates

Study Major Dates

• Study Start (Estimated): January 2, 2026
• Primary Completion (Estimated): March 2, 2026
• Study Completion (Estimated): March 14, 2026

Study Registration Dates

• First Submitted: December 31, 2025
• First Submitted That Met QC Criteria: December 31, 2025
• First Posted (Estimated): January 12, 2026

Study Record Updates

• Last Update Posted (Estimated): January 12, 2026
• Last Update Submitted That Met QC Criteria: December 31, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Balance; Gait; Electromyography; Postural stability; Neuromuscular training; Biodex; Anterior foot wedge
• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Parkinson Disease; Mobility Limitation
• Other Study ID Numbers: PT. BU. EC. 29

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No