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

MTI University

Status: Not yet enrolling

Conditions: Postural Instability; Parkinson's Disease; Gait Disorder

Treatments: Behavioral: Neuromuscular training; Device: Anterior foot wedge

Study type: Interventional

Funder types: Other

Identifiers

NCT07334847

PT. BU. EC. 29

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 45 to 75 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Neuromuscular Training + Anterior Foot Wedge + Conventional PT

Experimental group

Description:

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.

Treatment:

Device: Anterior foot wedge

Behavioral: Neuromuscular training

Conventional Physical Therapy Only

Active Comparator group

Description:

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.

Treatment:

Behavioral: Neuromuscular training