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临床试验/NCT04029285
NCT04029285已完成不适用

The Effects of Exergaming on Pain, Postural Control, Technology Acceptance and Flow Experience in Older People With Chronic Musculoskeletal Pain: a Randomised Controlled Trial

Teesside University2 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2010年9月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
54
试验地点
2
主要终点
Change in rate of change of centre of pressure (mm.s-1) location - eyes closed.

研究概览

简要总结

Chronic musculoskeletal pain is debilitating and can lower the quality of life in older people. Therapeutic benefits have been reported from exergaming used as an intervention for rehabilitation or alternative to exercise. This study investigated the effects of exergaming in comparison with those of standard exercise on pain, postural control, technology acceptance and flow experience in older people with musculoskeletal pain.

详细描述

Study design: A prospective, randomized, controlled two-arm trial design: Group 1) exergaming with the Interactive Rehabilitation and Exercise System (IREX®) and Group 2) traditional gym-based exercise (TGB).

Ethical Approval was sought from and granted by the School of Health and Social Care Research Governance and Ethics Committee at Teesside University on 20th September 2010 The study was conducted in the Physiotherapy Research Laboratory, Constantine Building, Teesside University.

Participants were recruited by non-direct contacts from nine local community groups in the Middlesbrough area.

Sixty-one potential participants were screened for eligibility. Four were excluded due to not meeting the eligibility criteria and three did not attend scheduled sessions. Fifty-four (42 females and 12 males, age: 71 ± 5 years) were allocated to either exergaming with the IREX™ (n = 27) or TGB (n = 27).

Procedure

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • male or female
  • aged 65 years or over
  • able to walk unassisted (i.e. did not use, or require, any walking aids) for at least 0.5 of a mile
  • having musculoskeletal pain in two or more joints, of more than 12 weeks duration

排除标准

  • diagnosis (or suspicion) of any systemic conditions that may cause pain in two or more joints
  • of more than 12 weeks duration (such as cancer, rheumatic or neurological disease or condition)
  • self-report of current (or history) of any condition or injury which would contra- indicate participation in the exercises under study
  • inability (or any doubt of ability) to give informed consent
  • inability to read and write English

研究组 & 干预措施

Traditional Gym Based exercise - Control

Other

Twice weekly sessions of TGB exercise for six weeks.

干预措施: Exergaming (Other)

Exergaming

Experimental

Twice weekly sessions of exergames for six weeks.

干预措施: Exergaming (Other)

结局指标

主要结局

Change in rate of change of centre of pressure (mm.s-1) location - eyes closed.

时间窗: Change in rate of change of centre of pressure (mm.s-1) location (eyes closed), from baseline to six weeks

Centre of pressure velocity (mm.s-1) is the rate at which the centre point of force (measured on a Kistler™ Force Plate) moves, as the participant stands on the force plate with their eyes closed. It is quantified in mm.s-1 and an increase represents faster movements and hence more rapid corrections of balance are required to maintain equilibrium and hence postural control has worsened.

Change in rate of change of centre of pressure (mm.s-1) location - eyes open.

时间窗: Change in centre of pressure velocity (mm.s-1) (eyes open), from baseline to six weeks

Centre of pressure velocity (mm.s-1) is the rate at which the centre point of force (measured on a Kistler™ Force Plate) moves, as the participant stands on the force plate with their eyes open. It is quantified in mm.s-1 and an increase represents faster movements and hence more rapid corrections of balance are required to maintain equilibrium and hence postural control has worsened.

Change in standard deviation of centre of pressure (mm) location measurements in the anterio-posterior direction - eyes open.

时间窗: Change in standard deviation of centre of pressure (mm) location measurements in the anterio-posterior direction (eyes open), from baseline to six weeks

Centre of pressure (CoP) is the centre point of force (measured on a Kistler™ Force Plate) as the participant stands on the force plate with their eyes open. The location of the CoP changes in the anterio-posterior direction (forwards to backwards) if the person sways forward and backward. The variability in the magnitude of sway is reflected in the Standard Deviation of this measure. It is quantified in mm and an increased variation in movement means that more varied corrections of balance are required to maintain equilibrium and hence postural control has worsened.

Change in Pain intensity (within previous 30 days) rating

时间窗: Change in Pain intensity (within previous 30 days) rating, from baseline to six weeks

Participants rated the intensity of their pain (within previous 30 days) on a 0-10 scale where 10 is the WORST POSSIBLE PAIN. An increased score represents greater pain.

Change in standard deviation of centre of pressure (mm) location measurements in the anterio-posterior direction - eyes closed.

时间窗: Change in standard deviation of centre of pressure (mm) location measurements in the anterio-posterior direction (eyes closed), from baseline to six weeks

Centre of pressure (CoP) is the centre point of force (measured on a Kistler™ Force Plate) as the participant stands on the force plate with their eyes closed. The location of the CoP changes in the anterio-posterior direction (forwards to backwards) if the person sways forward and backward. The variability in the magnitude of sway is reflected in the Standard Deviation of this measure. It is quantified in mm and an increased variation in movement means that more varied corrections of balance are required to maintain equilibrium and hence postural control has worsened.

Change in score on each sub-scale included in the Flow State Scale (FSS) (Jackson and Marsh, 1996).

时间窗: Change in score on each sub-scale included in the Flow State Scale questionnaire, from baseline to six weeks

FSS comprises 36 questions rated on a 5-point Likert scale 1 strongly disagree to 5 strongly agree, grouped into nine subscales. 1. autotelic experience, the intrinsically rewarding experience doing a task 2. clear goals, clearly confident of action 3. challenge-skill-balance, balance between skills and challenge 4. concentration at task, complete control on performing a task 5. control, at full focus at the task 6. unambiguous feedback, feedback on performing a task 7. action-awareness-merging, immediate, direct and clear observations whilst performing a task 8. transformation of time, sense of time speeds or slows, becomes irrelevant or out of one's awareness 9. loss of self consciousness, sense of not being concerned with oneself while engaged in a task Question ratings are summed to give subscale score. An increased score in any subscale reflects an increase in the experience of Flow State (a positive outcome in respect of experience of any activity).

Change in Pain intensity (at present time) rating

时间窗: Change in Pain intensity (within previous 30 days) rating, from baseline to six weeks

Participants rated the intensity of their pain (within previous 30 days) on a 0-10 scale where 10 is the WORST POSSIBLE PAIN. An increased score represents greater pain.

Change in score, on each cluster included in the Multi Affect and Pain Survey (MAPS) questionnaire (Clark, 2002).

时间窗: Change in MAPS Cluster Score, from baseline to six weeks

MAPS comprises three superclusters reflecting three major aspects of pain: somatosensory, emotional and well-being. 1. somatosensory supercluster contains 17 clusters with 57 descriptors of painful sensory qualities 2. emotional supercluster has 8 clusters with 26 descriptors of negative emotional qualities 3. well-being supercluster has 5 clusters with 18 descriptors of positive affect, and health. Descriptors are presented as statements and participants rate how closely each comes to describing how they feel on a six point scale (from 0 (Not at all) to 5 (Very much so)). Descriptor scores are summed to give Cluster scores. An increased score in somatosensory and emotional clusters reflects a worsening, in well-being it reflects an improvement.

Change in range of centre of pressure (mm) location measurements in the anterior-posterior direction - eyes open.

时间窗: Change in range of centre of pressure (mm) location measurements in the anterior-posterior direction (eyes open), from baseline to six weeks

Centre of pressure (CoP) is the centre point of force (measured on a Kistler™ Force Plate) as the participant stands on the force plate with their eyes open. The location of the CoP changes in the anterio-posterior direction (forwards to backwards) if the person sways forward and backward. The extent of maximal and minimal magnitude of sway is reflected in the Range of this measure. It is quantified in mm and an increase represents larger movements occurred and so correspondingly larger corrections of balance are required, to maintain equilibrium and hence postural control has worsened.

Change in standard deviation of centre of pressure (mm) location measurements in the medio-lateral direction - eyes open.

时间窗: Change in standard deviation of centre of pressure (mm) location measurements in the medio-lateral direction (eyes open), from baseline to six weeks

Centre of pressure (CoP) is the centre point of force (measured on a Kistler™ Force Plate) as the participant stands on the force plate with their eyes open. The location of the CoP changes in the medio-lateral direction (side-to-side) if the person sways from side to side. The variability in the magnitude of sway is reflected in the Standard Deviation of this measure. It is quantified in mm and an increased variation in movement means that more varied corrections of balance are required to maintain equilibrium and hence postural control has worsened.

Change in range of centre of pressure (mm) location measurements in the medio-lateral direction - eyes open.

时间窗: Change in range of centre of pressure (mm) location measurements in the medio-lateral direction (eyes open), from baseline to six weeks

Centre of pressure (CoP) is the centre point of force (measured on a Kistler™ Force Plate) as the participant stands on the force plate with their eyes open. The location of the CoP changes in the medio-lateral direction (side-to-side) if the person sways from side to side. The extent of maximal and minimal magnitude of sway is reflected in the Range of this measure. It is quantified in mm and an increase represents larger movements occurred and so correspondingly larger corrections of balance are required, to maintain equilibrium and hence postural control has worsened.

Change in range of centre of pressure (mm) location measurements in the anterior-posterior direction - eyes closed.

时间窗: Change in range of centre of pressure (mm) location measurements in the anterior-posterior direction(eyes closed), from baseline to six weeks

Centre of pressure (CoP) is the centre point of force (measured on a Kistler™ Force Plate) as the participant stands on the force plate with their eyes closed. The location of the CoP changes in the anterio-posterior direction (forwards to backwards) if the person sways forward and backward. The extent of maximal and minimal magnitude of sway is reflected in the Range of this measure. It is quantified in mm and an increase represents larger movements occurred and so correspondingly larger corrections of balance are required, to maintain equilibrium and hence postural control has worsened.

Change in standard deviation of centre of pressure (mm) location measurements in the medio-lateral direction - eyes closed.

时间窗: Change in standard deviation of centre of pressure (mm) location measurements in the medio-lateral direction (eyes closed), from baseline to six weeks

Centre of pressure (CoP) is the centre point of force (measured on a Kistler™ Force Plate) as the participant stands on the force plate with their eyes closed. The location of the CoP changes in the medio-lateral direction (side-to-side) if the person sways from side to side. The variability in the magnitude of sway is reflected in the Standard Deviation of this measure. It is quantified in mm and an increased variation in movement means that more varied corrections of balance are required to maintain equilibrium and hence postural control has worsened.

Change in range of centre of pressure (mm) location measurements in the medio-lateral direction - eyes closed.

时间窗: Change in range of centre of pressure (mm) location measurements in the medio-lateral direction(eyes closed), from baseline to six weeks

Centre of pressure (CoP) is the centre point of force (measured on a Kistler™ Force Plate) as the participant stands on the force plate with their eyes closed. The location of the CoP changes in the medio-lateral direction (side-to-side) if the person sways from side to side. The extent of maximal and minimal magnitude of sway is reflected in the Range of this measure. It is quantified in mm and an increase represents larger movements occurred and so correspondingly larger corrections of balance are required, to maintain equilibrium and hence postural control has worsened.

Change in score on each domain included in the Technology Acceptance: United Theory of Acceptance and Use of Technology (UTAUT) questionnaire (Venkatesh, 2003).

时间窗: Change in score on each domain included in the Technology Acceptance: United Theory of Acceptance and Use of Technology (UTAUT) questionnaire, from baseline to six weeks

The UTAUT comprises statements rated on a 7-point Likert scale, 1 strongly disagree to 7 strongly agree, grouped into six domains. 1. performance expectancy, the belief that using a system will help improve performance, 2. effort expectancy, how easy it is to use the technology 3. social influence, how much the user believes others think they should use the technology 4. facilitation conditions, how much the user believes they should use the technology, 5. self-efficacy, how capable the user feel to use the technology 6. behavioural intention, intention to use the technology again. Statement ratings are summed to give Domain scores. An increased score in any Domain reflects an increase in acceptance (positive outcome in respect of technology usage).

次要结局

未报告次要终点

研究者

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

Alasdair MacSween

Principal Lecturer (Research Governance)

Teesside University

研究点 (2)

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