Clinical trial NCT02572011: Transtibial Amputee Balance Training: A Randomised Controlled Trial
Official title: A Games-console Based Balance Training Intervention for Transtibial Amputees: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Lower Limb Amputation
Keywords: Lower limb amputation
Transtibial
Balance
Postural Control
Limits of Stability
Rehabilitation
Home-based intervention
Nintendo Wii
Balance Board
Lead sponsor: Nottingham Trent University
Sponsor class: OTHER
Collaborators: name: Nottingham University Hospitals NHS Trust
name: University of Hull
name: Bournemouth University
name: Jonkoping University
First posted: 2015-10-08
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: Limits of Stability Test Protocol Directional Control Score
timeFrame: Baseline to 3 Month Follow-Up
measure: The Berg Balance Scale
timeFrame: Baseline to 3 Month Follow-Up
Secondary outcomes:
measure: Falling
timeFrame: Baseline to 1 Year Follow-Up
measure: Falls Efficacy
timeFrame: Baseline to 3 Month Follow-Up
measure: The Prosthesis Evaluation Questionnaire
timeFrame: Baseline to 3 Month Follow-Up
measure: The Short form-36 Questionnaire
timeFrame: Baseline to 3 Month Follow-Up
measure: The Activities and Balance Confidence Scale
timeFrame: Baseline to 3 Month Follow-Up
measure: Centre of Mass Dynamics
timeFrame: Baseline to 3 Month Follow-Up
measure: Limits of Stability Test Protocol Maximal Excursion Score
timeFrame: Baseline to 3 Month Follow-Up
measure: Limits of Stability Test Protocol Reaction Time Score
timeFrame: Baseline to 3 Month Follow-Up
measure: Limits of Stability Test Protocol Movement Velocity Score
timeFrame: Baseline to 3 Month Follow-Up
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: The Biomechanics Lab, CELS Building, Nottingham Trent University
state: Notts
city: Nottingham
country: United Kingdom
facility: The Mobility Centre, City Hospital, NUH NHS Trust
state: Notts
Study officials:
affiliation: Nottingham Trent University
name: Cleveland T Barnett, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: