Musculoskeletal PainNCT04029285
Exergaming Experience of Older People With Chronic Musculoskeletal Pain
A study testing Exergaming in people with Musculoskeletal Pain and Musculoskeletal Pain Disorder, run by Teesside University at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Musculoskeletal Pain, Musculoskeletal Pain Disorder
- What is being tested?
- Exergaming
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Sep 2010to 16 Sep 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Teesside University, School of Health and Social Care
Middlesbrough, Cleveland, TS1 3BA
About this study
Official title: The Effects of Exergaming on Pain, Postural Control, Technology Acceptance and Flow Experience in Older People With Chronic Musculoskeletal Pain: a Randomised Controlled Trial
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.
Read the detailed description
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
On arrival for data collection at the Physiotherapy Research Laboratory at Teesside University, participants were asked if they had further questions about the study. These questions, if any, were answered. The study Consent Form was then signed. Participants' demographic details and all outcome measures were recorded, after which the participants were randomised by stratified blind-card allocation (picking a sealed opaque envelope).
Data extraction
Range and Standard Deviation (SD) of Centre of Pressure (CoP) displacements in the anterior-posterior (AP) and medio-lateral (ML) directions (CoPAP SD, CoPAP range, CoPML SD, CoPML range - all mm) and the resultant CoP velocity (mm.sec-1) were extracted from the force platform using Bioware software (Kistler™), after low-pass filtering of the raw data at 10 Hz. CoP velocity (mm.sec-1) was calculated.
Statistical analysis
Data was analysed with Version 19 of the Statistical Package for the Social Sciences (SPSS, Chicago, Illinois, USA). Analysis of covariance (ANCOVA) was used to assess between-group final scores for each outcome measure used with baseline scores as covariate. Variables that did not meet the assumption of homogeneity of variance were analysed by two-way independent measures ANOVA with blocking using mean splits of scored pre-measures. Mixed analysis of variance (ANOVA) was used to determine any within-subject changes over time. All analyses used a significance level of 0.05. The effect size measure epsilon squared was used, where values of 0.01, 0.06 and 0.14 were interpreted as small, moderate and large.
- Being tested
- Exergaming
- Keywords
- Exergaming, Exercise Therapy, Musculoskeletal Pain, Aged, Aged 80 and Over, Postural Balance, Flow state experience, Technology acceptance, Heart Rate
- Medical subject headings
- Musculoskeletal Pain, Collagen Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExergamingOther
The exergaming group played six IREX® exergames. Those in the TGB group performed exercises that were matched to the IREX® exergames for: movement patterns required, physiological demands, sequence, duration and mode of exercise by adopting open and closed kinetic chain movements, in the same range and loading, across both groups. Each IREX® exergame was played for two minutes and was repeated three times within a session. TGB exercise was conducted in sets of two minutes duration, repeated three times within a session. In both groups participants were given rest periods of 10 to 30 seconds, or longer, if required, between exergames or TGB exercise sets.
| Study group | Role | What they receive |
|---|---|---|
| Traditional Gym Based exercise - Control | Other | Twice weekly sessions of TGB exercise for six weeks. Receives: Other: Exergaming |
| Exergaming | Experimental | Twice weekly sessions of exergames for six weeks. Receives: Other: Exergaming |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in score, on each cluster included in the Multi Affect and Pain Survey (MAPS) questionnaire (Clark, 2002).
MAPS comprises three superclusters reflecting three major aspects of pain: somatosensory, emotional and well-being.
- somatosensory supercluster contains 17 clusters with 57 descriptors of painful sensory qualities
- emotional supercluster has 8 clusters with 26 descriptors of negative emotional qualities
- 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.
Measured: Change in MAPS Cluster Score, from baseline to six weeks
Change in Pain intensity (within previous 30 days) rating
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.
Measured: Change in Pain intensity (within previous 30 days) rating, from baseline to six weeks
Change in Pain intensity (at present time) rating
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.
Measured: Change in Pain intensity (within previous 30 days) rating, from baseline to six weeks
Change in rate of change of centre of pressure (mm.s-1) location - eyes open.
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.
Measured: Change in centre of pressure velocity (mm.s-1) (eyes open), from baseline to six weeks
Change in standard deviation of centre of pressure (mm) location measurements in the anterio-posterior direction - eyes open.
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.
Measured: Change in standard deviation of centre of pressure (mm) location measurements in the anterio-posterior direction (eyes open), from baseline to six weeks
Change in range of centre of pressure (mm) location measurements in the anterior-posterior direction - eyes open.
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.
Measured: Change in range of centre of pressure (mm) location measurements in the anterior-posterior direction (eyes open), from baseline to six weeks
Change in standard deviation of centre of pressure (mm) location measurements in the medio-lateral direction - eyes open.
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.
Measured: Change in standard deviation of centre of pressure (mm) location measurements in the medio-lateral direction (eyes open), from baseline to six weeks
Change in range of centre of pressure (mm) location measurements in the medio-lateral direction - eyes open.
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.
Measured: Change in range of centre of pressure (mm) location measurements in the medio-lateral direction (eyes open), from baseline to six weeks
Change in rate of change of centre of pressure (mm.s-1) location - eyes closed.
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.
Measured: Change in rate of change of centre of pressure (mm.s-1) location (eyes closed), from baseline to six weeks
Change in standard deviation of centre of pressure (mm) location measurements in the anterio-posterior direction - eyes closed.
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.
Measured: Change in standard deviation of centre of pressure (mm) location measurements in the anterio-posterior direction (eyes closed), from baseline to six weeks
Change in range of centre of pressure (mm) location measurements in the anterior-posterior direction - eyes closed.
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.
Measured: Change in range of centre of pressure (mm) location measurements in the anterior-posterior direction(eyes closed), from baseline to six weeks
Change in standard deviation of centre of pressure (mm) location measurements in the medio-lateral direction - eyes closed.
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.
Measured: Change in standard deviation of centre of pressure (mm) location measurements in the medio-lateral direction (eyes closed), from baseline to six weeks
Change in range of centre of pressure (mm) location measurements in the medio-lateral direction - eyes closed.
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.
Measured: Change in range of centre of pressure (mm) location measurements in the medio-lateral direction(eyes closed), from baseline to six weeks
Change in score on each domain included in the Technology Acceptance: United Theory of Acceptance and Use of Technology (UTAUT) questionnaire (Venkatesh, 2003).
The UTAUT comprises statements rated on a 7-point Likert scale, 1 strongly disagree to 7 strongly agree, grouped into six domains.
- performance expectancy, the belief that using a system will help improve performance,
- effort expectancy, how easy it is to use the technology
- social influence, how much the user believes others think they should use the technology
- facilitation conditions, how much the user believes they should use the technology,
- self-efficacy, how capable the user feel to use the technology
- 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).
Measured: 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
Change in score on each sub-scale included in the Flow State Scale (FSS) (Jackson and Marsh, 1996).
FSS comprises 36 questions rated on a 5-point Likert scale 1 strongly disagree to 5 strongly agree, grouped into nine subscales.
- autotelic experience, the intrinsically rewarding experience doing a task
- clear goals, clearly confident of action
- challenge-skill-balance, balance between skills and challenge
- concentration at task, complete control on performing a task
- control, at full focus at the task
- unambiguous feedback, feedback on performing a task
- action-awareness-merging, immediate, direct and clear observations whilst performing a task
- transformation of time, sense of time speeds or slows, becomes irrelevant or out of one's awareness
- 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).
Measured: Change in score on each sub-scale included in the Flow State Scale questionnaire, from baseline to six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2019
- Study start20 Sep 2010
- Primary completion31 Mar 2011
- Study completion16 Sep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were assigned to either the control group (TGB) or the experimental group (exergaming) in parallel for the duration of the study.
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teesside University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alasdair MacSween, Teesside University
- Investigators
- Alasdair MacSween, Principal investigator, Teesside University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04029285
- Sponsor's protocol ID
- ExergamingOldPeople
- Status last verified
- Jul 2019
- First submitted
- 18 Jul 2019
- Last updated
- 23 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Clark CW, Yang JC, Tsui SL, Ng KF, Clark SB. Unidimensional pain rating scales: a multidimensional affect and pain survey (MAPS) analysis of what they really measure. Pain. 2002 Aug;98(3):241-247. doi: 10.1016/S0304-3959(01)00474-2.
PubMed 12127025Jackson SA. Toward a conceptual understanding of the flow experience in elite athletes. Res Q Exerc Sport. 1996 Mar;67(1):76-90. doi: 10.1080/02701367.1996.10607928.
PubMed 8735997Shamliyan TA, Wang SY, Olson-Kellogg B, Kane RL. Physical Therapy Interventions for Knee Pain Secondary to Osteoarthritis [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2012 Nov. Report No.: 12(13)-EHC115-EF. Available from http://www.ncbi.nlm.nih.gov/books/NBK114568/
PubMed 23213666Ditchburn JL, van Schaik P, Dixon J, MacSween A, Martin D. The effects of exergaming on pain, postural control, technology acceptance and flow experience in older people with chronic musculoskeletal pain: a randomised controlled trial. BMC Sports Sci Med Rehabil. 2020 Oct 9;12:63. doi: 10.1186/s13102-020-00211-x. eCollection 2020.
PubMed 33062284
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Exergaming on Pain, Postural Control, Technology Acceptance and Flow Experience in Older People With Chronic Musculoskeletal Pain: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04029285
- Acronym / sponsor ID
- ExergamingOldPeople
- Keywords
- Exergaming, Exercise Therapy, Musculoskeletal Pain, Aged, Aged 80 and Over, Postural Balance, Flow state experience, Technology acceptance, Heart Rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Teesside UniversityUniversity, hospital or other
- Study start
- 20 Sep 2010 (actual)
- Primary completion
- 31 Mar 2011 (actual)
- Study completion
- 16 Sep 2011 (actual)
- First posted
- 23 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
On arrival for data collection at the Physiotherapy Research Laboratory at Teesside University, participants were asked if they had further questions about the study. These questions, if any, were answered. The study Consent Form was then signed. Participants' demographic details and all outcome measures were recorded, after which the participants were randomised by stratified blind-card allocation (picking a sealed opaque envelope).
Data extraction
Range and Standard Deviation (SD) of Centre of Pressure (CoP) displacements in the anterior-posterior (AP) and medio-lateral (ML) directions (CoPAP SD, CoPAP range, CoPML SD, CoPML range - all mm) and the resultant CoP velocity (mm.sec-1) were extracted from the force platform using Bioware software (Kistler™), after low-pass filtering of the raw data at 10 Hz. CoP velocity (mm.sec-1) was calculated.
Statistical analysis
Data was analysed with Version 19 of the Statistical Package for the Social Sciences (SPSS, Chicago, Illinois, USA). Analysis of covariance (ANCOVA) was used to assess between-group final scores for each outcome measure used with baseline scores as covariate. Variables that did not meet the assumption of homogeneity of variance were analysed by two-way independent measures ANOVA with blocking using mean splits of scored pre-measures. Mixed analysis of variance (ANOVA) was used to determine any within-subject changes over time. All analyses used a significance level of 0.05. The effect size measure epsilon squared was used, where values of 0.01, 0.06 and 0.14 were interpreted as small, moderate and large.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were assigned to either the control group (TGB) or the experimental group (exergaming) in parallel for the duration of the study.
| Arm | Type | Receives |
|---|---|---|
| Traditional Gym Based exercise - Control | Other | Other: ExergamingTwice weekly sessions of TGB exercise for six weeks. |
| Exergaming | Experimental | Other: ExergamingTwice weekly sessions of exergames for six weeks. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExergamingThe exergaming group played six IREX® exergames. Those in the TGB group performed exercises that were matched to the IREX® exergames for: movement patterns required, physiological demands, sequence, duration and mode of exercise by adopting open and closed kinetic chain movements, in the same range and loading, across both groups. Each IREX® exergame was played for two minutes and was repeated three times within a session. TGB exercise was conducted in sets of two minutes duration, repeated three times within a session. In both groups participants were given rest periods of 10 to 30 seconds, or longer, if required, between exergames or TGB exercise sets. | Other | Exergaming, Traditional Gym Based exercise - Control |
Primary outcome
Change in score, on each cluster included in the Multi Affect and Pain Survey (MAPS) questionnaire (Clark, 2002).
Time frame: 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 Pain intensity (within previous 30 days) rating
Time frame: 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 Pain intensity (at present time) rating
Time frame: 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 rate of change of centre of pressure (mm.s-1) location - eyes open.
Time frame: 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.
Time frame: 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 range of centre of pressure (mm) location measurements in the anterior-posterior direction - eyes open.
Time frame: 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.
Time frame: 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.
Time frame: 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 rate of change of centre of pressure (mm.s-1) location - eyes closed.
Time frame: 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 standard deviation of centre of pressure (mm) location measurements in the anterio-posterior direction - eyes closed.
Time frame: 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 range of centre of pressure (mm) location measurements in the anterior-posterior direction - eyes closed.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Change in score on each sub-scale included in the Flow State Scale (FSS) (Jackson and Marsh, 1996).
Time frame: 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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2019.
- Background: PubMed 12127025Clark CW, Yang JC, Tsui SL, Ng KF, Clark SB. Unidimensional pain rating scales: a multidimensional affect and pain survey (MAPS) analysis of what they really measure. Pain. 2002 Aug;98(3):241-247. doi: 10.1016/S0304-3959(01)00474-2.
- Background: PubMed 8735997Jackson SA. Toward a conceptual understanding of the flow experience in elite athletes. Res Q Exerc Sport. 1996 Mar;67(1):76-90. doi: 10.1080/02701367.1996.10607928.
- Background: PubMed 23213666Shamliyan TA, Wang SY, Olson-Kellogg B, Kane RL. Physical Therapy Interventions for Knee Pain Secondary to Osteoarthritis [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2012 Nov. Report No.: 12(13)-EHC115-EF. Available from http://www.ncbi.nlm.nih.gov/books/NBK114568/
- Derived from this study: PubMed 33062284Ditchburn JL, van Schaik P, Dixon J, MacSween A, Martin D. The effects of exergaming on pain, postural control, technology acceptance and flow experience in older people with chronic musculoskeletal pain: a randomised controlled trial. BMC Sports Sci Med Rehabil. 2020 Oct 9;12:63. doi: 10.1186/s13102-020-00211-x. eCollection 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alasdair MacSween principal investigator
Teesside University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exergaming in people with Musculoskeletal Pain and Musculoskeletal Pain Disorder, run by Teesside University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in score, on each cluster included in the Multi Affect and Pain Survey (MAPS) questionnaire (Clark, 2002). (time frame: Change in MAPS Cluster Score, from baseline to six weeks). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04029285, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2019.