Transtibial Amputee Balance Training: A Randomised Controlled Trial

March 12, 2019 updated by: Dr. Cleveland T. Barnett, Nottingham Trent University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Notts
      • Nottingham, Notts, United Kingdom, NG11 8NS
        • The Biomechanics Lab, CELS Building, Nottingham Trent University
      • Nottingham, Notts, United Kingdom, NG5 1PB
        • The Mobility Centre, City Hospital, NUH NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control
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.
Other: Home-based Games Console Balance Training
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline to 3 Month Follow-Up
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.
Baseline to 3 Month Follow-Up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Falling
Time Frame: Baseline to 1 Year Follow-Up
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
Time Frame: Baseline to 3 Month Follow-Up
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
Time Frame: Baseline to 3 Month Follow-Up
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
Time Frame: Baseline to 3 Month Follow-Up
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
Time Frame: Baseline to 3 Month Follow-Up
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
Time Frame: Baseline to 3 Month Follow-Up
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
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 maximal excursion score (%) will be produced from this test protocol.
Baseline to 3 Month Follow-Up
Limits of Stability Test Protocol Reaction Time 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 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
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 movement velocity score (degrees/second) will be produced from this test protocol.
Baseline to 3 Month Follow-Up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nottingham Trent University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Hull
Nottingham University Hospitals NHS Trust
Bournemouth University
Jonkoping University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Cleveland T Barnett, Ph.D, Nottingham Trent University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 6, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 7, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 8, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 14, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NTU127818

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lower Limb Amputation

Clinical Trials on Home-based Games Console Balance Training

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings