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Not yet recruiting NCT07334847

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

No phase Interventional Parkinson's Disease Postural Instability Gait Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Anterior foot wedge, Neuromuscular training.
Who it may be relevant to
Registry conditions: Parkinson's Disease, Postural Instability, Gait Disorder. Basic parameters: 45 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

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.

Interventions

  • 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.

Primary outcome measures

  • Change in Limit of Stability (LOS) [Time frame: Baseline and after 8 weeks of intervention (24 sessions)]
Secondary outcome measures (5)
  • Change in Gait Disability (UPDRS Score) [Time frame: Baseline and after 8 weeks]
  • Change in Step Length [Time frame: Baseline and after 8 weeks]
  • Change in Walking Velocity [Time frame: Baseline and after 8 weeks]
  • Change in Cadence [Time frame: Baseline and after 8 weeks]
  • Change in Electromyographic (EMG) Amplitude of Trunk Muscles [Time frame: Baseline and after 8 weeks]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07334847 · PT. BU. EC. 29

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗