Effects of Customized Foot Orthoses With Orthotic Wedges on Lower-extremity Muscle Activity During Standing and Gait in the Patients With Plantar Heel Pain: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Pain intensity and foot function
研究概览
简要总结
The present study will use a randomized controlled trial (RCT) to determine the effectiveness of customized foot orthosis (CFO) for the treatment of patients with PHP. Three treatment groups including the CFO without wedge, the CFO with wedge type 1 (W1), and the CFO with wedge type 2 (W2) will be randomly assigned to each participant by a computer-generated randomization. The opaque-sealed envelopes will be used to allocate the groups of participant.
详细描述
Participants will be allocated to the control (CFO without wedge) or experimental (CFO with W1 or W2) groups according to the seal-envelop randomization technique. Then, they will be assessed all outcomes for the baseline including pain intensity, foot function, lower-extremity muscle activity during gait and standing by the 2nd physical therapist. And the participants will receive the assigned treatment by the 1st physical therapist.
All participants will be asked to use the CFO in daily life during weight-bearing activities, and logbook, chat LINE, or phone call will be used to monitor the participants during the treatment program. They will be asked about activity they done in daily and a number of hour they used CFO per day in diary book. At least 4 hours per day of wearing CFO will be required to each participant. After 3 months of the CFO use, all outcomes will be re-assessed by the 2nd physical therapist. And such outcomes will be then statistically analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Participants will be allocated to the control (CFO without wedge) or experimental (CFO with W1 or W2) groups according to the seal-envelop randomization technique. Then, they will be assessed all outcomes for the baseline including pain intensity, foot function, lower-extremity muscle activity during gait and standing by the 2nd physical therapist. And the participants will receive the assigned treatment by the 1st physical therapist.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Reaching the specific criteria of PHP including
- •A complaint of tenderness from the palpation of the medial calcaneal tubercle and the medial aspect of the proximal portion of the plantar fascia, or pain along the plantar fascia at medial longitudinal arch side
- •The presence of heel pain immediately during the first few steps of walking in the morning or after a prolonged period of inactivity; and gradually decreased throughout the day with ordinary walking, and worsened with prolonged activity
- •Having the symptom of heel pain for at least 6 weeks, indicates the chronic condition
- •Having the maximum level of pain intensity during last week using the visual analog scale (VAS) at least 3 out of a full 10 scores
排除标准
- •Having positive sciatica test, indicating the L5-S1 nerve root irritation
- •Having a history of lower extremity fracture
- •Having a history of lower extremity surgery
- •Having been diagnosed with gout, diabetic neuropathy, rheumatoid arthritis, systemic lupus erythematosus (SLE), cancer, infectious disease, and tumor
研究组 & 干预措施
CFO with W2
The therapists will propose the orthotic wedges after examining the foot angles following the foot assessment from the study of Monaghan et al., the forefoot will be posted at 50% of the measured forefoot angle, and the rearfoot will be posted at 20% of the measured rearfoot angle. After the posting, all participants will be asked to test the provided foot orthoses within their footwear. If any disturbance has been found during testing, the adjustment will be performed.
干预措施: orthotic wedge (Device)
CFO with W2
The therapists will propose the orthotic wedges after examining the foot angles following the foot assessment from the study of Monaghan et al., the forefoot will be posted at 50% of the measured forefoot angle, and the rearfoot will be posted at 20% of the measured rearfoot angle. After the posting, all participants will be asked to test the provided foot orthoses within their footwear. If any disturbance has been found during testing, the adjustment will be performed.
干预措施: CFO (Device)
CFO without wedge
The 3-quarter-length CFO will be made from thermoplastic material (rigid foot orthoses) which consists of four layers i.e. two layers of 0.5-mm polyvinyl chloride (PVC), one layer of 1.5-mm thick fiber to increase strength of foot orthoses in the bottom layers as well as one layer of 1.2-mm genuine leather in the upper layer to increase comfort. It incorporates a heat-molding process to adjust individual foot shape in prone position. The materials will be set within approximately three minutes.
干预措施: CFO (Device)
CFO with W1
The therapists will propose the orthotic wedges after examining the foot angles following the foot assessment from the study of Root, the forefoot angle will be determined for both the forefoot and rearfoot wedges. Previous studies recommended the posting at 60% of the measured forefoot angle, up to a maximum of 8 degrees, for extrinsic forefoot varus wedge and the posting at 50% of the measured forefoot angle, up to a maximum of 6 degrees, for extrinsic rearfoot varus wedge. After the posting, all participants will be asked to test the provided foot orthoses within their footwear. If any disturbance has been found during testing, the adjustment will be performed.
干预措施: orthotic wedge (Device)
CFO with W1
The therapists will propose the orthotic wedges after examining the foot angles following the foot assessment from the study of Root, the forefoot angle will be determined for both the forefoot and rearfoot wedges. Previous studies recommended the posting at 60% of the measured forefoot angle, up to a maximum of 8 degrees, for extrinsic forefoot varus wedge and the posting at 50% of the measured forefoot angle, up to a maximum of 6 degrees, for extrinsic rearfoot varus wedge. After the posting, all participants will be asked to test the provided foot orthoses within their footwear. If any disturbance has been found during testing, the adjustment will be performed.
干预措施: CFO (Device)
结局指标
主要结局
Pain intensity and foot function
时间窗: Baseline, 3 months
Pain intensity during the last week will be assessed using the visual analog scale (VAS) which is the high-reliability measurement (ICC = 0.88). The highest pain level is 10 and the lowest pain level is 0. In addition, the foot function will be assessed by the 23-item foot function index (FFI). The present study will use the Thai version of FFI that has been translated forward and backward from the English version. The previous study showed high internal consistency (Cronbach alpha = 0.98) and high test-retest reliability (ICC = 0.86). It is appropriate to use among patients with PHP.
EMG of lower leg muscles
时间窗: Baseline, 3 months
A Trigno Wireless EMG system at 2000 Hz (Delsys Inc., Boston, MA) will be used to collect the EMG data from Tibialis anterior, Peroneus longus, Medial gastrocnemius, Biceps femoris, and Rectus femoris in both legs. The skin will be cleaned with alcohol wipes and the standard EMG electrodes will be positioned following the SENIAM guidelines. Raw EMG data will be exported to Visual3D (C-Motion Inc., Germantown, USA). The dependent variables for the peak and integrated EMG (iEMG) values from such muscles will be found. Then, the data will be normalized to the maximal observed signal during the dynamic contraction during the movement tasks. The participants will be asked to stand with both legs on the firm and foam surface in two conditions i.e. eye closed and eye open, for 20 s in each condition. And then, they will be asked to walk at a self-selected speed to the other end of the 3-m pressure distribution platform.
次要结局
未报告次要终点