Parkinson's DiseaseAFW-NTNCT07334847
Anterior Foot Wedge With Neuromuscular Training for Balance in Parkinson's Disease
A study testing Anterior foot wedge and Neuromuscular training in people with Parkinson's Disease and Postural Instability, run by MTI University.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Parkinson's Disease, Postural Instability, Gait Disorder
- What is being tested?
- Anterior foot wedge and Neuromuscular training
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 2 Jan 2026to 14 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy of Anterior Foot Wedge Modulation With Neuromuscular Training on Balance During Walking in Parkinsonian Patients
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.
Read more
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.
- Conditions
- Parkinson's Disease, Postural Instability, Gait Disorder
- Being tested
- Anterior foot wedge, Neuromuscular training
- Keywords
- Anterior foot wedge, Neuromuscular training, Balance, Gait, Biodex, Electromyography, Postural stability
- Medical subject headings
- Parkinson Disease, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Neuromuscular Training + Anterior Foot Wedge + Conventional PT | Experimental | 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. Receives: Device: Anterior foot wedge; Behavioral: Neuromuscular training |
| Conventional Physical Therapy Only | Active comparator | 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. Receives: Behavioral: Neuromuscular training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline and after 8 weeks of intervention (24 sessions)
Secondary outcomes (5)
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).
Measured: Baseline and after 8 weeks
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.
Measured: Baseline and after 8 weeks
Change in Walking Velocity
Measured via motion analysis system during a 10-meter walk test. Reported in meters per second.
Measured: Baseline and after 8 weeks
Change in Cadence
Number of steps per minute during walking, recorded by motion analysis system.
Measured: Baseline and after 8 weeks
Change in Electromyographic (EMG) Amplitude of Trunk Muscles
Surface 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.
Measured: Baseline and after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start2 Jan 2026 (estimated)
- Primary completion2 Mar 2026 (estimated)
- Study completion14 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- "Two-group randomized controlled trial comparing conventional physical therapy (control) versus conventional therapy plus anterior foot wedge and neuromuscular training (experimental)."
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MTI University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, reda abd elrazik, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07334847
- Sponsor's protocol ID
- PT. BU. EC. 29
- Acronym
- AFW-NT
- Status last verified
- Dec 2025
- First submitted
- 31 Dec 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Anterior Foot Wedge Modulation With Neuromuscular Training on Balance During Walking in Parkinsonian Patients
- ClinicalTrials.gov ID
- NCT07334847
- Acronym / sponsor ID
- AFW-NT / PT. BU. EC. 29
- Conditions
- Parkinson's Disease, Postural Instability, Gait Disorder
- Keywords
- Anterior foot wedge, Neuromuscular training, Balance, Gait, Biodex, Electromyography, Postural stability
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- MTI UniversityUniversity, hospital or other
- Study start
- 2 Jan 2026 (estimated)
- Primary completion
- 2 Mar 2026 (estimated)
- Study completion
- 14 Mar 2026 (estimated)
- First posted
- 12 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- "Two-group randomized controlled trial comparing conventional physical therapy (control) versus conventional therapy plus anterior foot wedge and neuromuscular training (experimental)."
| Arm | Type | Receives |
|---|---|---|
| Neuromuscular Training + Anterior Foot Wedge + Conventional PT | Experimental | Device: Anterior foot wedge, Behavioral: Neuromuscular trainingParticipants 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. |
| Conventional Physical Therapy Only | Active comparator | Behavioral: Neuromuscular trainingarticipants 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. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anterior foot wedgeA 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. | Device | Neuromuscular Training + Anterior Foot Wedge + Conventional PT |
| Neuromuscular trainingA 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. | Behavioural | Conventional Physical Therapy Only, Neuromuscular Training + Anterior Foot Wedge + Conventional PT |
Primary outcome
Change in Limit of Stability (LOS)
Time frame: 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).
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Anterior foot wedge and Neuromuscular training in people with Parkinson's Disease and Postural Instability, run by MTI University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Reda kotb gadelhak (+966532476201, dr_reda_kotb@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Limit of Stability (LOS) (time frame: Baseline and after 8 weeks of intervention (24 sessions)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.