Lower Limb AmputationNCT02572011
Transtibial Amputee Balance Training: A Randomised Controlled Trial
A study testing Home-based Games Console Balance Training in people with Lower Limb Amputation, run by Nottingham Trent University at 2 sites in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lower Limb Amputation
- What is being tested?
- Home-based Games Console Balance Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Dec 2015to Dec 2018
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Unilateral transtibial amputee to fit research design and must have at least 12 months experience using their prosthetic limb independently following discharge from in-patient treatment
- Minimum of 18 years old. There are no gender requirements - Age requirements in order to self-consent to participate, thus no child protection issues.
- Able to travel - Data collection takes place at University campus where participants will attend data collection sessions.
- Able to use prosthesis without pain or discomfort for a minimum of two hours at a time - Must be able to use prosthesis in order to complete tasks required for this research.
- Able to stand for periods of up to 2 minutes, unaided and without walking aid to complete tasks required for assessment where participants are required to stand on a force platform and perform some volitional postural movements.
Who cannot join
- Current musculoskeletal injury - Risk of further injury could be increased.
- Unable to follow instruction or cognitive deficits - Risk of further injury whilst completing tasks incorrectly.
- Bilateral amputation - In order to have a homogenous group of amputees in terms of categorisation of amputation.
- Unable to perform tasks due to current medical condition e.g. rheumatoid arthritis - Risk of worsening current condition and/or causing further injury.
- Experience pain or discomfort whilst wearing prosthesis - Risk of further injury and/or worsening of current condition. To be assessed by clinical team when individual is informed of study.
- Does not use prosthesis regularly.
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- Not able to understand written and verbal English - All communication will be in English as the University does not have a service available that will be able to cope with translation demands.
- Currently taking medication known to affect balance adversely - Risk of falling during balance training and/or data collection sessions.
- Current Training - Participants must not be currently using the Nintendo Wii or similar systems in a structured balance training program.
- Inability to provide informed consent
- Substantial changes to the physical condition of the lower limb - If after consenting and participating in the study, individuals are referred to mobility services due to a degradation of the physical condition of either lower limb, they will be excluded from the study.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
The Biomechanics Lab, CELS Building, Nottingham Trent University
Nottingham, Notts, NG11 8NS
The Mobility Centre, City Hospital, NUH NHS Trust
Nottingham, Notts, NG5 1PB
About this study
Official title: A Games-console Based Balance Training Intervention for Transtibial Amputees: A Randomised Controlled Trial
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.
Read the detailed description
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.
- Conditions
- Lower Limb Amputation
- Being tested
- Home-based Games Console Balance Training
- Keywords
- Lower limb amputation, Transtibial, Balance, Postural Control, Limits of Stability, Rehabilitation, Home-based intervention, Nintendo Wii, Balance Board
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based Games Console Balance TrainingOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Home-based Games Console Balance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline to 3 Month Follow-Up
Secondary outcomes (9)
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.
Measured: Baseline to 1 Year Follow-Up
Falls Efficacy
Participants will complete the Modified Falls Efficacy scale in order to assess their falls efficacy.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to 3 Month Follow-Up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2015 (estimated)
- Study startDec 2015
- Primary completionDec 2018
- Study completionDec 2018
Why it stopped: Poor recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Limb AmputationStudies 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
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nottingham Trent University
- Sponsor type
- University, hospital or other
- Collaborators
- Nottingham University Hospitals NHS Trust, University of Hull, Bournemouth University, Jonkoping University
- Responsible party
- Principal investigator, Dr. Cleveland T. Barnett, Nottingham Trent University
- Investigators
- Cleveland T Barnett, Ph.D, Principal investigator, Nottingham Trent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02572011
- Sponsor's protocol ID
- NTU127818
- Status last verified
- Mar 2019
- First submitted
- 6 Oct 2015
- Last updated
- 14 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Games-console Based Balance Training Intervention for Transtibial Amputees: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02572011
- Acronym / sponsor ID
- NTU127818
- Conditions
- Lower Limb Amputation
- Keywords
- Lower limb amputation, Transtibial, Balance, Postural Control, Limits of Stability, Rehabilitation, Home-based intervention, Nintendo Wii
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor recruitment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Nottingham Trent UniversityUniversity, hospital or other
- Collaborators
- Nottingham University Hospitals NHS Trust, University of Hull, Bournemouth University, Jonkoping University
- Study start
- Dec 2015
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 8 Oct 2015 (estimated)
- 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants in the control (CON) group will not complete any formalised balance training as part of the current study. |
| Experimental | Experimental | Other: Home-based Games Console Balance TrainingParticipants in the experimental group will complete the Home-based Games Console Balance Training intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Unilateral transtibial amputee to fit research design and must have at least 12 months experience using their prosthetic limb independently following discharge from in-patient treatment
- Minimum of 18 years old. There are no gender requirements - Age requirements in order to self-consent to participate, thus no child protection issues.
- Able to travel - Data collection takes place at University campus where participants will attend data collection sessions.
- Able to use prosthesis without pain or discomfort for a minimum of two hours at a time - Must be able to use prosthesis in order to complete tasks required for this research.
- Able to stand for periods of up to 2 minutes, unaided and without walking aid to complete tasks required for assessment where participants are required to stand on a force platform and perform some volitional postural movements.
Key exclusion criteria (11 listed)
- Current musculoskeletal injury - Risk of further injury could be increased.
- Unable to follow instruction or cognitive deficits - Risk of further injury whilst completing tasks incorrectly.
- Bilateral amputation - In order to have a homogenous group of amputees in terms of categorisation of amputation.
- Unable to perform tasks due to current medical condition e.g. rheumatoid arthritis - Risk of worsening current condition and/or causing further injury.
- Experience pain or discomfort whilst wearing prosthesis - Risk of further injury and/or worsening of current condition. To be assessed by clinical team when individual is informed of study.
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 |
|---|---|---|
| Home-based Games Console Balance TrainingThe 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). | Other | Experimental |
Primary outcome
Limits of Stability Test Protocol Directional Control Score
Time frame: Baseline to 3 Month Follow-Up
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.
The Berg Balance Scale
Time frame: Baseline to 3 Month Follow-Up
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.
9 secondary outcomes
Falling
Time frame: Baseline to 1 Year Follow-Up
Falls Efficacy
Time frame: Baseline to 3 Month Follow-Up
The Prosthesis Evaluation Questionnaire
Time frame: Baseline to 3 Month Follow-Up
The Short form-36 Questionnaire
Time frame: Baseline to 3 Month Follow-Up
The Activities and Balance Confidence Scale
Time frame: Baseline to 3 Month Follow-Up
Centre of Mass Dynamics
Time frame: Baseline to 3 Month Follow-Up
Limits of Stability Test Protocol Maximal Excursion Score
Time frame: Baseline to 3 Month Follow-Up
Limits of Stability Test Protocol Reaction Time Score
Time frame: Baseline to 3 Month Follow-Up
Limits of Stability Test Protocol Movement Velocity Score
Time frame: Baseline to 3 Month Follow-Up
Results and safety
The study was stopped early (reason given: Poor recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2019.
- 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.
Cleveland T Barnett, Ph.D principal investigator
Nottingham Trent University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based Games Console Balance Training in people with Lower Limb Amputation, run by Nottingham Trent University at 2 sites 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 5 inclusion and 11 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: stopped early, as of the sponsor's last update on 14 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 was stopped early (reason given: Poor recruitment). Results are not available in the source record.
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?
Limits of Stability Test Protocol Directional Control Score (time frame: Baseline to 3 Month Follow-Up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Mar 2019.