Effects of Gait Biofeedback and Impairment-based Rehabilitation in Individuals With Chronic Ankle Instability
试验速览
- 阶段
- 3 期
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change from Baseline Ankle Frontal Plane Angle During Gait
研究概览
简要总结
Individuals with chronic ankle instability (CAI) have demonstrated altered gait patterns. Gait training may be necessary to address these alterations as protocols focusing solely on strength or balance have not been shown to impact walking gait. Biofeedback about the foot position during walking may help improve gait biomechanics. The purpose is to determine whether a 4-week rehabilitation program that includes biofeedback has beneficial effects on self-reported function and ankle gait kinematics compared to rehabilitation alone in people with CAI. The design is a single-blinded randomized controlled trial. Participants will complete baseline self-reported function questionnaires and walking gait trials and then be randomized to complete 4- weeks of supervised rehabilitation with or without audiovisual biofeedback. Follow up emails will ask for participant information about ankle health and to complete questionnaires about their ankle for 6 months and 12 months after completing rehabilitation.
详细描述
This study will require 10 visits for all participants. Both groups will participate in baseline and follow-up gait assessments involving walking on a treadmill at 1.34 m/s. Follow-up visits will be conducted within 72 hours of the participant's final rehabilitation session. Using a rigid cluster marker setup, reflective markers will be placed on the upper back, sacrum, and bilaterally on the thigh, shank, rearfoot, and forefoot. A 5-minute familiarization period will be completed to ensure participants are comfortable and walking as normally as possible. Following the familiarization period, 1-minute of continuous gait data will be collected. The data collected during baseline and follow-up gait assessments will be used to analyze the primary and secondary outcome measures for kinematics. Participants will also complete the patient reported outcomes (FAAM ADL & Sport Subscale) at the baseline and follow-up visits.
Impairment-based Rehabilitation:
Four weeks of supervised rehabilitation (8 sessions) will be provided to both groups. This rehabilitation paradigm has been previously reported by Donovan and Hertel. Impairment-based rehabilitation involves identifying and treating deficits in 4 broad domains including range of motion (ROM), strength, balance, and functional exercises by using an "asses, treat, re-assess" approach. Previously reported intervention methods will be used in this study. The clinician administering the rehabilitation will be blinded to the subjects' intervention group status.
Intervention:
Gait training using visual feedback for frontal plane ankle position at initial contact (IC) will be projected onto a screen in front of the treadmill.
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
- Single (Care Provider)
盲法说明
Clinician involved in rehabilitation will not know if participant has been enrolled in the gait biofeedback arm or the control (no biofeedback) arm.
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>1 Ankle Sprain (>12 months prior)
- •Physically active (>1.5 hr/week)
- •> 10 on Identification of Functional Ankle Instability (IdFAI)
- •< 90 Foot and Ankle Ability Measure (FAAM) Activities of Daily Living (ADL)
- •< 85 FAAM Sport
排除标准
- •Hx of LE fracture
- •Hx of LE surgery
- •Hx of ankle sprain within last 6 weeks
- •Participating in physical therapy for ankle
- •Multiple Sclerosis
- •Marfan's Syndrome
- •Lumbosacral Radiculopathy
- •Ehlers-Danlos Syndrome
- •Diabetes Mellitus
- •Pregnant (self-reported)
- •Unable to provide informed consent
研究组 & 干预措施
Gait Biofeedback
This group will receive audiovisual feedback about the position of their foot during walking. Feedback will be provided over 8 total sessions.
干预措施: Gait Biofeedback (Other)
Control
This arm will not receive any audiovisual feedback about the position of their foot during walking.
结局指标
主要结局
Change from Baseline Ankle Frontal Plane Angle During Gait
时间窗: Baseline, 4 weeks
Ankle frontal plane angle will be assessed throughout the gait cycle using ensemble curves analysis.
次要结局
- Change from Baseline Hip Transverse Plane Angle During Gait(Baseline, 4 weeks)
- Change from Baseline Ankle Sagittal Plane Angle During Gait(Baseline, 4 weeks)
- Change from Baseline Hip Frontal Plane Angle During Gait(Baseline, 4 weeks)
- Change from Baseline Balance(Baseline, 4 weeks)
- Change from Baseline Strength(Baseline, 4 weeks)
- Change from Baseline Ankle Transverse Plane Angle During Gait(Baseline, 4 weeks)
- Change from Baseline Knee Sagittal Plane Angle During Gait(Baseline, 4 weeks)
- Change from Baseline Knee Transverse Plane Angle During Gait(Baseline, 4 weeks)
- Change from Baseline Hip Sagittal Plane Angle During Gait(Baseline, 4 weeks)
- Change from Baseline Physical Activity(Baseline, 4 weeks)
- Change from Baseline Knee Frontal Plane Angle During Gait(Baseline, 4 weeks)
- Change from Baseline Range of motion(Baseline, 4 weeks)
- Change from Baseline Foot and Ankle Ability Measure (FAAM)(Baseline, 4 weeks)
- Change from Baseline Visual Analog Scale (VAS)(Baseline, 4 weeks)
- Change from Baseline Foot and Ankle Ability Measure (FAAM) Sport(Baseline, 4 weeks)
- Change from Baseline International Physical Activity Questionnaire(Baseline, 4 weeks)
- Change from Baseline Identification of Functional Ankle Instability (IdFAI)(Baseline, 4 weeks)
- Change from Baseline Tampa Scale if Kinesiophobia (TSK)(Baseline, 4 weeks)
- The Global Rating of Change (GROC) Score(4 weeks)
研究者
Jay Hertel, PhD, ATC
Principal Investigator
University of Virginia