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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07334847
Acronym
AFW-NT
Enrollment
30
Registered
2026-01-12
Start date
2026-01-02
Completion date
2026-03-14
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gait Disorder, Parkinson's Disease, Postural Instability

Keywords

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

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.

Interventions

DEVICEAnterior 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.

BEHAVIORALNeuromuscular 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.

Sponsors

MTI University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Change in Limit of Stability (LOS)Baseline and after 8 weeks of intervention (24 sessions)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).

Secondary

MeasureTime frameDescription
Change in Gait Disability (UPDRS Score)Baseline and after 8 weeksAssessed 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).
Change in Step LengthBaseline and after 8 weeksMeasured using a 3D motion analysis system (Hocoma, Model 000341, USA). Average step length (distance between successive heel strikes) in centimeters during comfortable walking speed.
Change in Walking VelocityBaseline and after 8 weeksMeasured via motion analysis system during a 10-meter walk test. Reported in meters per second.
Change in CadenceBaseline and after 8 weeksNumber of steps per minute during walking, recorded by motion analysis system.
Change in Electromyographic (EMG) Amplitude of Trunk MusclesBaseline and after 8 weeksSurface EMG (Neuropac S1, Model DI 90B, Japan) used to record amplitude of motor unit action potentials (in microvolts, µV) from rectus abdominis and erector spinae muscles during standing and walking tasks.

Contacts

Primary ContactReda kotb gadelhak
dr_reda_kotb@yahoo.com+966532476201

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026