Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07334847

Anterior Foot Wedge With Neuromuscular Training for Balance in Parkinson's Disease

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Gait Disorder Mobility Limitation Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Postural Instability Signs and Symptoms Synucleinopathies

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Anterior foot wedge

Device

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.

Neuromuscular training

Behavioral

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.

Primary outcomes

  1. Change in Limit of Stability (LOS)

    Time frame: Baseline and after 8 weeks of intervention (24 sessions)

    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).

Secondary outcomes

  1. Change in Gait Disability (UPDRS Score)

    Time frame: Baseline and after 8 weeks

    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).

  2. Change in Step Length

    Time frame: Baseline and after 8 weeks

    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.

  3. Change in Walking Velocity

    Time frame: Baseline and after 8 weeks

    Measured via motion analysis system during a 10-meter walk test. Reported in meters per second.

  4. Change in Cadence

    Time frame: Baseline and after 8 weeks

    Number of steps per minute during walking, recorded by motion analysis system.

  5. Change in Electromyographic (EMG) Amplitude of Trunk Muscles

    Time frame: Baseline and after 8 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Reda kotb gadelhak

CONTACT

[email protected]

+966532476201

Sponsors and collaborators

Lead sponsor

MTI University

Other

Registry information

Official study title

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

Acronym: AFW-NT

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 12, 2026
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.