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临床试验/NCT05455645
NCT05455645Unknown不适用

The Therapeutic Effect of Targeted Intrinsic Foot Muscles Exercises in Plantar Fasciitis

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2022年8月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
64
试验地点
1
主要终点
cross sectional area (CSA) of Abductor Hallucis (AbH), Flexor hallucis brevis (FHB), Flexor digitorum brevis (FDB), quadratus plantae (QP)

研究概览

简要总结

A reduction of intrinsic foot muscle sizes has been identified in patients with chronic plantar fasciitis. Weaker intrinsic foot muscles has been suggested to decrease the medial longitudinal arch height and subsequently increase extra tensile stress in the plantar fascia, resulting in the chronicity of the condition. Therefore, it is speculated that atrophic intrinsic foot muscles may be a significant risk factor of developing chronic plantar fasciitis. The purpose of this study is to investigate the effect of an 8-week targeted intrinsic foot muscles exercise regimen on the intrinsic foot muscle size, symptomatic relief, and foot function improvement in long-distance runners with chronic plantar fasciitis.

详细描述

Distance runners are defined as running with more than 20km per week for more than 2 years. All recruited participants have > 1 year of plantar fasciitis. The diagnosis were made based on clinical symptoms and the thickness of plantar fasciitis > 4.0mm at the medial tubercle of heel by ultrasound imaging.

Arm 1: The purpose of this arm of the study is to determine if a 8-week targeted foot muscle exercise regimen, instructed with real-time ultrasound, affect the intrinsic foot muscle size, symptomatic relief, and foot function improvement of distance runners with plantar fasciitis. 32 participants will be recruited in this arm.

Arm 2: This group will not engage in any training, but will serve as a comparator for the intervention arm.

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
Double (Participant, Outcomes Assessor)

盲法说明

Team members collecting outcomes data will not know participant allocation

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •A weekly mileage of at least 20km
  • •Have running experience of at least 2 years prior to the experiment
  • •if they reported tenderness on palpation of the medial calcaneal tuberosity and exhibited one of the following complaints:
  • •Plantar heel pain > 1 year
  • •Pain on visual analog scale of equal to or greater than 4 out of 10
  • •pain on the first step in the morning or after prolonged sitting,
  • •pain on prolonged standing and/or walking
  • •pain when running

排除标准

  • •Contraindications to MRI scans
  • •had undergone surgery to the plantar fascia or
  • •local steroid injection within the last 3 months or
  • •Any of the following conditions:
  • •systemic arthritis,
  • •neurologic conditions
  • •any coexisting painful musculoskeletal condition of the lower limb.

研究组 & 干预措施

Targeted intrinsic foot muscles exercise regimen

Experimental

4 targeted intrinsic foot exercise will be performed at least 5 times per week, once in the laboratory, and four times at home. The participants will be followed up weekly at the laboratory visit. The real-time ultrasound imaging of intrinsic foot muscles will be used as guided visual biofeedback to instruct all participants to execute all exercise movement in a correct manner. If the participant misses a session, he/she is expected to replace the lost session within the same week.

干预措施: targeted intrinsic foot muscle exercises (Other)

Control

No Intervention

continue normal physical activity,

结局指标

主要结局

cross sectional area (CSA) of Abductor Hallucis (AbH), Flexor hallucis brevis (FHB), Flexor digitorum brevis (FDB), quadratus plantae (QP)

时间窗: week 12

ultrasound measurement

muscle thickness (MT) of Abductor Hallucis (AbH), Flexor hallucis brevis (FHB), Flexor digitorum brevis (FDB), quadratus plantae (QP)

时间窗: week 12

ultrasound measurement

Visual Analog Scale (VAS) pain at first steps in the morning

时间窗: week 12

measuring 100 mm in length marked from 0 (absence of pain) to 100 mm (worst imaginable pain)

Navicular Drop test

时间窗: week 12

Supinated foot (\<5mm); Neutral foot (5-9mm); pronated foot (\>9mm)

Visual Analog Scale (VAS) worst pain of the day

时间窗: 12

measuring 100 mm in length marked from 0 (absence of pain) to 100 mm (worst imaginable pain)

Foot and Ankle Ability Measure (FAAM)

时间窗: week 12

Higher scores represent higher levels of function, with 100% representing no dysfunction.

Foot posture index

时间窗: week 12

Pronated postures are given a positive value, the higher the value the more pronated. Supinated features are given a negative value, the more negative the value the more supinated. For a neutral foot the final score should lie somewhere around zero

muscle thickness (MT) of Abductor Hallucis (AbH), Flexor hallucis brevis (FHB), Flexor digitorum brevis (FDB), quadratus plantae (QP)

时间窗: baseline

ultrasound measurement

muscle thickness (MT) of Abductor Hallucis (AbH), Flexor hallucis brevis (FHB), Flexor digitorum brevis (FDB), quadratus plantae (QP)

时间窗: week 4

ultrasound measurement

muscle thickness (MT) of Abductor Hallucis (AbH), Flexor hallucis brevis (FHB), Flexor digitorum brevis (FDB), quadratus plantae (QP)

时间窗: week 8

ultrasound measurement

cross sectional area (CSA) of Abductor Hallucis (AbH), Flexor hallucis brevis (FHB), Flexor digitorum brevis (FDB), quadratus plantae (QP)

时间窗: Baseline

ultrasound measurement

cross sectional area (CSA) of Abductor Hallucis (AbH), Flexor hallucis brevis (FHB), Flexor digitorum brevis (FDB), quadratus plantae (QP)

时间窗: week 4

ultrasound measurement

cross sectional area (CSA) of Abductor Hallucis (AbH), Flexor hallucis brevis (FHB), Flexor digitorum brevis (FDB), quadratus plantae (QP)

时间窗: week 8

ultrasound measurement

Visual Analog Scale (VAS) pain at first steps in the morning

时间窗: baseline

measuring 100 mm in length marked from 0 (absence of pain) to 100 mm (worst imaginable pain)

Visual Analog Scale (VAS) pain at first steps in the morning

时间窗: week 4

measuring 100 mm in length marked from 0 (absence of pain) to 100 mm (worst imaginable pain)

Visual Analog Scale (VAS) pain at first steps in the morning

时间窗: week 8

measuring 100 mm in length marked from 0 (absence of pain) to 100 mm (worst imaginable pain)

Visual Analog Scale (VAS) worst pain of the day

时间窗: baseline

measuring 100 mm in length marked from 0 (absence of pain) to 100 mm (worst imaginable pain)

Visual Analog Scale (VAS) worst pain of the day

时间窗: 4

measuring 100 mm in length marked from 0 (absence of pain) to 100 mm (worst imaginable pain)

Visual Analog Scale (VAS) worst pain of the day

时间窗: 8

measuring 100 mm in length marked from 0 (absence of pain) to 100 mm (worst imaginable pain)

Foot and Ankle Ability Measure (FAAM)

时间窗: baseline

Higher scores represent higher levels of function, with 100% representing no dysfunction.

Foot and Ankle Ability Measure (FAAM)

时间窗: week 4

Higher scores represent higher levels of function, with 100% representing no dysfunction.

Foot and Ankle Ability Measure (FAAM)

时间窗: week 8

Higher scores represent higher levels of function, with 100% representing no dysfunction.

Navicular Drop test

时间窗: week 8

Supinated foot (\<5mm); Neutral foot (5-9mm); pronated foot (\>9mm)

Foot posture index

时间窗: baseline

Pronated postures are given a positive value, the higher the value the more pronated. Supinated features are given a negative value, the more negative the value the more supinated. For a neutral foot the final score should lie somewhere around zero

Foot posture index

时间窗: week 4

Pronated postures are given a positive value, the higher the value the more pronated. Supinated features are given a negative value, the more negative the value the more supinated. For a neutral foot the final score should lie somewhere around zero

Foot posture index

时间窗: week 8

Pronated postures are given a positive value, the higher the value the more pronated. Supinated features are given a negative value, the more negative the value the more supinated. For a neutral foot the final score should lie somewhere around zero

Navicular Drop test

时间窗: baseline

Supinated foot (\<5mm); Neutral foot (5-9mm); pronated foot (\>9mm)

Navicular Drop test

时间窗: week 4

Supinated foot (\<5mm); Neutral foot (5-9mm); pronated foot (\>9mm)

次要结局

  • Postural control(week 12)
  • Postural control(baseline)
  • Postural control(week 4)
  • Postural control(week 8)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lau On Yue

Principal Investigator

Chinese University of Hong Kong

研究点 (1)

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