Cognitive Behavioral Based Physical Therapy to Improve Functional Outcomes in Patients With Chronic Ankle Instability: a Pilot Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Number of Prescribed Sessions Attended per Subject
研究概览
简要总结
The purpose of this study is to investigate the feasibility of a psychologically informed physical therapy intervention in individuals with Chronic Ankle Instability.
详细描述
This project will target the psychological impairments in addition to pathomechanical and motor behavior impairment in individuals with Chronic Ankle Instability, using a cognitive behavioral based physical therapy approach. All participants will first complete a baseline assessment, then will be randomly assigned to treatment groups (CBPT/home exercise program (HEP) or HEP only) using a random number generator by an investigator not involved in participant screening, outcome measures, or intervention administration. Individuals in the CBPT/HEP group will participate in six sessions of 45 minutes each for three weeks (two sessions a week). After three weeks, a post-assessment will be completed for both groups.
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
investigators involved in participant screening, outcome measures, and intervention administration
入排标准
- 年龄范围
- 19 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of at least one ankle sprain (initial sprain at least 1 year prior to participation)
- •Reported foot and ankle ability measure-sports scale (FAAM-sport) <85, identification of functional ankle instability (IdFAI) >10
排除标准
- •History of other lower extremity fracture or surgery
- •Ankle sprain within the past 6-weeks
- •Any conditions known to affect balance
- •Pregnancy
- •Any neurological or psychological problems
- •Individuals already participating in rehabilitation
结局指标
主要结局
Number of Prescribed Sessions Attended per Subject
时间窗: 3 weeks
At least 85% of subjects must complete follow-up testing. A subject who attends post-intervention visit at 3 weeks has completed the follow-up testing.
Percentage of Subjects Completing All Prescribed Sessions Within 3 Weeks
时间窗: 3 weeks
At least 80% of subjects must attend all the sessions prescribed. Attendance means the subject has showed up and completed the tasks for the session.
Number of Intervention-Related Serious Adverse Events Per Group Within 3 Weeks
时间窗: 3 weeks
Adverse events are recorded as unfavorable events in which a subject has unintentional and abnormal signs or symptoms temporarily associated with participation in the intervention. The number of adverse events in the intervention group should be similar to that of the control group and will not exceed three serious adverse events related to the intervention.
Change from baseline kinesiophobia at 3 weeks (post-intervention)
时间窗: 3 weeks
The Tampa Scale of Kinesiophobia (11-question version), which uses a 4-point Likert scale, will be used to assess fear of movement. Individual item scores range from 1-4. Total score is the sum of all scores. Minimum possible total score is 11 and maximum possible total score is 44. Higher scores indicate a worse outcome or greater fear of movement.
Change from baseline self-efficacy at 3 weeks (post-intervention)
时间窗: 3 weeks
Self-efficacy will be assessed using the 17-item self-efficacy questionnaire. 17 statements of physical activity are scored from 0-100% according to subject's perceived ability to carry out the tasks in the statement. Total score is the average of all scores. Higher scores represent a better outcome or greater self-efficacy.
Change from baseline physical activity at 3 weeks (post-intervention)
时间窗: 3 weeks
Physical activity will be measured by daily steps recorded using Actigraph activity monitor watches.
Change from baseline health related quality of life at 3 weeks (post-intervention)
时间窗: 3 weeks
Health related quality of life will be assessed using the Disablement in the Physically Active Scale. Individual scores range from 0-4. Total scores are calculated as a sum of individual scores. 2 sub-scales (physical summary component and mental summary component) are calculated along with a total score. Physical summary component scores range from 0-48. Mental summary component scores range from 0-16. Total scores range from 0-64. Higher scores represent worse outcome or worse health related quality of life.
Change from baseline foot and ankle range of motion at 3 weeks (post-intervention)
时间窗: 3 weeks
Foot and ankle range of motion will be measured using clinical goniometry techniques and recorded in the unit of degrees.
Change from baseline dynamic balance at 3 weeks (post-intervention)
时间窗: 3 weeks
Dynamic balance will be measured using a modified Star Excursion Balance Test and reported as a relative distance (%).
次要结局
- Change from baseline center of force anterior-posterior excursion balance (cm)(3 weeks)
- Change from baseline foot and ankle muscle strength (Newtons)(3 weeks)
- Change from baseline center of force left-right excursion balance (cm)(3 weeks)
- Change from baseline center of force total area (cm^2)(3 weeks)
研究者
Abbis Jaffri
Principal Investigator
Creighton University