Health TrialsbyHealthPanel

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

ConditionsParkinson's DiseasePostural InstabilityGait Disorder
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-75
SponsorMTI University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Neuromuscular Training + Anterior Foot Wedge + Conventional PTExperimental treatment 2 interventions
Group B: Conventional Physical Therapy OnlyActive comparator 1 intervention

Trial outcomes

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).

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

Secondary outcomes

1

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).

Time frame
Baseline and after 8 weeks
2

Change in Step Length

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.

Time frame
Baseline and after 8 weeks
3

Change in Walking Velocity

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

Time frame
Baseline and after 8 weeks
4

Change in Cadence

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

Time frame
Baseline and after 8 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

MTI University

Lead sponsor

Benha University

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: