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Poor recruitment
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| Name | Class |
|---|---|
| Nottingham University Hospitals NHS Trust | OTHER |
| University of Hull | OTHER |
| Bournemouth University | OTHER |
| Jonkoping University |
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Lower limb amputees have reduced joint mobility and strength which negatively influence an individual's ability to maintain balance. Individuals with lower limb amputation also have an increased fear of falling and reduced social participation because of this fear. Improving balance ability, reducing falls and fear of falling through effective balance training interventions would have a number of socio-economic benefits. The aim of the current study is to investigate whether taking part in a games console based-balance intervention, improves balance ability in individuals with lower limb amputation.
Lower limb amputation (LLA) results in the loss of the biological joint structures such as the ankle and knee, along with the associated musculature. This reduces joint mobility and strength and thus adversely affects amputees' ability to maintain balance. As a result, individuals with a LLA have been shown to fall more often when compared to age-matched and otherwise healthy individuals. In addition, individuals with LLA also have an increased fear of falling and reduced social participation because of this fear. Improving balance ability, reducing falls and fear of falling in this patient group through effective balance training interventions would have a number of socio-economic benefits. Such benefits may include but are not limited to reduced care costs, reduced burden on healthcare services and an improved sense of patient well-being. Therefore, the main aim of the current randomised control trial (RCT) is to investigate whether taking part in a games console based-balance intervention, improves experienced LLAs balance ability. The RCT also aims to assess how this intervention affects an amputee's falls rate, fear of falling and quality of life. After providing informed consent, unilateral lower limb amputees will be randomly allocated to one of two groups; an experimental group (12-week balance training intervention) or a control group (no intervention). Amputees in the experimental group will be loaned the use of a games console for the duration of the home-based intervention. Balance ability, falls rate, fear of falling and quality of life will be assessed prior to and post the intervention period as well as after three months following the end of the intervention period. Falls rate will also assessed one year post the intervention period. Results from the current study will provide evidence for the use of games-console based balance interventions in improving balance and falls outcomes for LLA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Participants in the control (CON) group will not complete any formalised balance training as part of the current study. | |
| Experimental | Experimental | Participants in the experimental group will complete the Home-based Games Console Balance Training intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home-based Games Console Balance Training | Other | The balance training intervention involves completing prescribed balance tasks for a minimum of 60 minutes per session, three times a week for 12 weeks (minimum intervention time of 2160 minutes) in their own home. Participants will perform the balance related Wii Fit games that have been suggested previously by professional bodies and amputee therapists (BACPAR Ossur Wii Fit Exercise Recommendations). |
| Measure | Description | Time Frame |
|---|---|---|
| Limits of Stability Test Protocol Directional Control Score | Participants will also be required to complete the Limits of Stability test (LOS) which measures a participant's ability to perform postural movements in order to voluntarily move their centre of gravity (COG) as they stand on a force platform. The LOS requires participants to move their COG in the direction of eight pre-determined target directions as quickly and as accurately as possible. The eight pre-determined target directions will be representative of an individuals' 100% limit of stability based upon their height. Assuming that the body acts as an inverted pendulum with rotation about the ankle, this relates to the amount of movement possible before the COG position necessitates adjustment of the base of support by stepping. The directional control score (%) will be produced from this test protocol. | Baseline to 3 Month Follow-Up |
| The Berg Balance Scale | Participants will complete the Berg Balance Scale, which involves the assessment of participants' ability to perform a number of functional tasks such as moving from standing to sitting, which are scored on a five point scale e.g. Needs assistance to sit (0) to sits safely with minimal use of hands (4). A total Berg Balance Scale score is calculated from this assessment. | Baseline to 3 Month Follow-Up |
| Measure | Description | Time Frame |
|---|---|---|
| Falling | Falls, defined as an unexpected event in which the participant comes to rest on the ground, floor or lower level' will be recorded using prospective daily recording procedure with participants recording the occurrence of falls in a falls log book. | Baseline to 1 Year Follow-Up |
| Falls Efficacy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cleveland T Barnett, Ph.D | Nottingham Trent University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Biomechanics Lab, CELS Building, Nottingham Trent University | Nottingham | Notts | NG11 8NS | United Kingdom | ||
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| OTHER |
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Participants will complete the Modified Falls Efficacy scale in order to assess their falls efficacy. |
| Baseline to 3 Month Follow-Up |
| The Prosthesis Evaluation Questionnaire | Participants will complete the Prosthesis Evaluation Questionnaire in order to assess their satisfaction with aspects concerning their prosthesis and their associated function. | Baseline to 3 Month Follow-Up |
| The Short form-36 Questionnaire | Participants will complete the Short form-36 questionnaire to assess their quality of life. | Baseline to 3 Month Follow-Up |
| The Activities and Balance Confidence Scale | Participants will complete the Activities and Balance Confidence Scale in order to assess their confidence in maintaining balance during activities of daily living. | Baseline to 3 Month Follow-Up |
| Centre of Mass Dynamics | Participants biomechanical function, specifically the dynamics (movement) of their centre of mass, during the Limits of Stability Test protocol will be assessed in order to understanding the underpinning mechanisms of balance in this population. | Baseline to 3 Month Follow-Up |
| Limits of Stability Test Protocol Maximal Excursion Score | Participants will also be required to complete the Limits of Stability test (LOS) which measures a participant's ability to perform postural movements in order to voluntarily move their centre of gravity (COG) as they stand on a force platform. The LOS requires participants to move their COG in the direction of eight pre-determined target directions as quickly and as accurately as possible. The eight pre-determined target directions will be representative of an individuals' 100% limit of stability based upon their height. Assuming that the body acts as an inverted pendulum with rotation about the ankle, this relates to the amount of movement possible before the COG position necessitates adjustment of the base of support by stepping. The maximal excursion score (%) will be produced from this test protocol. | Baseline to 3 Month Follow-Up |
| Limits of Stability Test Protocol Reaction Time Score | Participants will also be required to complete the Limits of Stability test (LOS) which measures a participant's ability to perform postural movements in order to voluntarily move their centre of gravity (COG) as they stand on a force platform. The LOS requires participants to move their COG in the direction of eight pre-determined target directions as quickly and as accurately as possible. The eight pre-determined target directions will be representative of an individuals' 100% limit of stability based upon their height. Assuming that the body acts as an inverted pendulum with rotation about the ankle, this relates to the amount of movement possible before the COG position necessitates adjustment of the base of support by stepping. The reaction time score (s) will be produced from this test protocol. | Baseline to 3 Month Follow-Up |
| Limits of Stability Test Protocol Movement Velocity Score | Participants will also be required to complete the Limits of Stability test (LOS) which measures a participant's ability to perform postural movements in order to voluntarily move their centre of gravity (COG) as they stand on a force platform. The LOS requires participants to move their COG in the direction of eight pre-determined target directions as quickly and as accurately as possible. The eight pre-determined target directions will be representative of an individuals' 100% limit of stability based upon their height. Assuming that the body acts as an inverted pendulum with rotation about the ankle, this relates to the amount of movement possible before the COG position necessitates adjustment of the base of support by stepping. The movement velocity score (degrees/second) will be produced from this test protocol. | Baseline to 3 Month Follow-Up |
| The Mobility Centre, City Hospital, NUH NHS Trust |
| Nottingham |
| Notts |
| NG5 1PB |
| United Kingdom |