Efficacy of Anterior Foot Wedge Modulation With Neuromuscular Training on Balance During Walking in Parkinsonian Patients
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Change in Limit of Stability (LOS)
概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
Neuromuscular Training + Anterior Foot Wedge + Conventional PT
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.
干预措施: Anterior foot wedge (Device)
Neuromuscular Training + Anterior Foot Wedge + Conventional PT
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.
干预措施: Neuromuscular training (Behavioral)
Conventional Physical Therapy Only
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.
干预措施: Neuromuscular training (Behavioral)
结局指标
主要结局
Change in Limit of Stability (LOS)
时间窗: 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).
次要结局
- Change in Gait Disability (UPDRS Score)(Baseline and after 8 weeks)
- Change in Step Length(Baseline and after 8 weeks)
- Change in Cadence(Baseline and after 8 weeks)
- Change in Walking Velocity(Baseline and after 8 weeks)
- Change in Electromyographic (EMG) Amplitude of Trunk Muscles(Baseline and after 8 weeks)
研究者
reda abd elrazik
Associate Professor of Physical Therapy
Benha University