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

NCT07334847 | Not Yet Recruiting

• 1 other identifier: PT. BU. EC. 29
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Postural Instability; Gait Disorder; Parkinson's Disease

Keywords

Anterior foot wedge; Neuromuscular training; Balance; Gait; Biodex; Electromyography; Postural stability

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change in Gait Disability (UPDRS Score)

  Baseline and after 8 weeks

• Change in Step Length

  Baseline and after 8 weeks

• Change in Walking Velocity

  Baseline and after 8 weeks

• Change in Cadence

  Baseline and after 8 weeks

• Change in Electromyographic (EMG) Amplitude of Trunk Muscles

  Baseline and after 8 weeks

Study Arms (2)

Neuromuscular Training + Anterior Foot Wedge + Conventional PT

EXPERIMENTAL

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; Behavioral: Neuromuscular training

Conventional Physical Therapy Only

ACTIVE COMPARATOR

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

Interventions

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 + Anterior Foot Wedge + Conventional PT

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.

Conventional Physical Therapy Only; Neuromuscular Training + Anterior Foot Wedge + Conventional PT

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• MTI University: lead

MeSH Terms

Conditions

Parkinson Disease; Mobility Limitation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Reda kotb gadelhak

CONTACT

+966532476201; dr_reda_kotb@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Physical Therapy

Model Details: "Two-group randomized controlled trial comparing conventional physical therapy (control) versus conventional therapy plus anterior foot wedge and neuromuscular training (experimental)."

Study Record Dates

• First Submitted: December 31, 2025
• First Posted: January 12, 2026
• Study Start: January 2, 2026
• Primary Completion: March 2, 2026
• Study Completion: March 14, 2026
• Last Updated: January 12, 2026

Record last verified: 2025-12