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

N/ANot Yet RecruitingNCT07334847

MTI University30 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Parkinson's Disease Postural Instability Gait Disorder

Interventions

Anterior foot wedgeDEVICE

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 trainingBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 45 YearsMax age: 75 Years

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

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).

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

Secondary Outcomes

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).