Transtibial Amputee Balance Training: A Randomised Controlled Trial

NCT02572011 | Terminated

• 1 other identifier: NTU127818
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 2

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.

Conditions

Lower Limb Amputation

Keywords

Lower limb amputation; Transtibial; Balance; Postural Control; Limits of Stability; Rehabilitation; Home-based intervention; Nintendo Wii; Balance Board

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (9)

• Falling

  Baseline to 1 Year Follow-Up

• Falls Efficacy

  Baseline to 3 Month Follow-Up

• The Prosthesis Evaluation Questionnaire

  Baseline to 3 Month Follow-Up

• The Short form-36 Questionnaire

  Baseline to 3 Month Follow-Up

• The Activities and Balance Confidence Scale

  Baseline to 3 Month Follow-Up

Study Arms (2)

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.

Other: Home-based Games Console Balance Training

Interventions

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).

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nottingham Trent University: lead
• Nottingham University Hospitals NHS Trust: collaborator
• University of Hull: collaborator
• Bournemouth University: collaborator
• Jonkoping University: collaborator

Study Sites (2)

The Biomechanics Lab, CELS Building, Nottingham Trent University

Nottingham, Notts, NG11 8NS, United Kingdom

Location

The Mobility Centre, City Hospital, NUH NHS Trust

Nottingham, Notts, NG5 1PB, United Kingdom

Location

Study Officials

• Cleveland T Barnett, Ph.D

  Nottingham Trent University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer in Biomechanics

Study Record Dates

• First Submitted: October 6, 2015
• First Posted: October 8, 2015
• Study Start: December 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: March 14, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)