Condition category
Injury, Occupational Diseases, Poisoning
Date applied
30/01/2012
Date assigned
13/03/2012
Last edited
31/07/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Strength and balance exercises have been shown in several studies to reduce the risk of falling in the elderly. However, older adults may not receive the full advantage offered by home rehabilitation either due to the lack of feedback on performance or due to reduced motivation to perform boring rehabilitation exercises. This study proposes:
1. The use of visual feedback of movement (visualisations) to provide advice on the recommended quality of movement to achieve the best recovery results; and advice on the main compensatory strategies, employed by the user, that may negatively affect the effectiveness of the exercises in the recovery of strength and balance.
2. The use of multimodal games to make rehabilitation more enjoyable for older adults.
We think that the use of visualizations and games for rehabilitation will be more effective than standard care, thereby improving adherence to home exercise, promoting independence, and improving the quality of life of older adults at risk of falling.

Who can participate?
Adults over the age of 65 who have been identified by the Glasgow Falls Service as being at risk of falling.

What does the study involve?
Participants will be randomly allocated to one of three groups. The control group will be given standard home rehabilitation care for falls (the Age UK instructional booklet). In the visualizations group, in addition to the standard rehabilitation care, participants will receive visual feedback during home exercise. These visualizations present the rehabilitation exercises to the participants using an animated mannequin that will demonstrate the correct range and speed of motion required for each exercise. They also show the users real-time feedback of their movements as they perform their exercises, provide a summary of their performance during the process, and provide information on the principles behind strength and balance exercises, and the role of these exercises in the prevention of falls. In the multimodal games group, in addition to standard care, the participants will be given multimodal games based on falls exercises to make rehabilitation more enjoyable. The games provide the users with a more interactive and enjoyable way to perform home exercise, and inform them on their performance and progress during rehabilitation by tracking game scores, achievements and user repetitions of movements during exercise.

What are the possible benefits and risks of participating?
Participants will be provided with tools that could potentially increase their motivation to perform home exercise, which in turn could help improve their gait, balance and mobility. In addition, the use of these tools could reduce their fear of falling (if present) and increase their quality of life. The multimodal activities and visualizations also have the potential to help the participants understand why each of the exercises is important to their recovery and assure them of the progress they are making during their rehabilitation.
Prior to the start of the trial the tools will also be evaluated with fallers in pilot studies. Furthermore, there will be a visit by the chief investigator and a research nurse (both trained on environmental risk assessment) to give training on the equipment and to assess the participants' homes on the suitability of the environment for home exercise. The advice on the environment and safety during exercise, as well as the advantages offered through the use of visual feedback and multimodal games for home rehabilitation, may be very beneficial to the participants, who otherwise may not receive these benefits.

Where is the study run from?
The study will take place in the users’ homes, while outcome assessments will be performed in a laboratory at the start and at the end of the trial.

When is the study starting and how long is it expected to run for?
The study is expected to run from March 2012 to July 2013. Participants will take part for only 12 weeks during this period, with an extra week for data collection.

Who is funding the study?
Medical Research Council (MRC) (UK) - Lifelong Health and Wellbeing initiative.

Who is the main contact?
Stephen Uzor
Stephen.uzor@gcu.ac.uk

Trial website

http://www.envisagerehab.co.uk/content/wp2-preventing-falls-community

Contact information

Type

Scientific

Primary contact

Prof Phillip Rowe

ORCID ID

Contact details

Bioengineering Unit
University of Strathclyde
106 Rottenrow
Glasgow
G4 0NW
United Kingdom
philip.rowe@strath.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Falls prevention advice and visual feedback to those at risk of falling: a randomized controlled trial

Acronym

Study hypothesis

1. The home based use of visual feedback of movement during exercise will be more effective than standard care in engaging older adults at risk of falling in home based rehabilitation; thereby improving adherence to exercise, and hence the quality of life of the user
2. The use of multimodal games will encourage greater participation and adherence to community-based falls rehabilitation programmes, thereby improving the users’ confidence, independence and quality of life

Ethics approval

NHS Greater Glasgow and Clyde Research Ethics Committee, 03 August 2011

Study design

Single-blind three arm parallel group randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Falls

Intervention

Participants who meet the inclusion criteria will be allocated to one of three groups:

1. Intervention A (Control): Participants in this group will be given that standard home rehabilitation care (Age UK instructional booklet).
2. Intervention B (Visualizations): In addition to the standard rehabilitation care, the participants in this group will receive visual feedback during home exercise. The main functions of these visualizations are:
2.1. To present the rehabilitation exercises to the participants using an animated mannequin that will demonstrate the correct range and speed of motion required for each exercise.
2.2. To show the users real time feedback of their movements as they perform their exercises and provide
a summary of their performance during the process.
2.3. To provide information on the principles behind strength and balance exercises, and the role of these
exercises in the prevention of falls.
3. Intervention C (Multimodal Games): In addition to standard care, the participants in this group will be given multimodal games based on falls exercises to make rehabilitation more enjoyable process for them. The games will serve two main functions during the trial:
3.1. To provide the users with a more interactive and enjoyable way to perform home exercise.
3.2. To inform the users on their performance and progress during rehabilitation by tracking game scores, achievements and user repetitions of movements during exercise.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Adherence to exercise will be recorded once at the end of the 12 week trial

Secondary outcome measures

1. Variability in stride length, stride time and double support time
2. Gait speed
3. Timed up and go (TUG) test
4. Falls efficacy scale international (FES-I)
5. Balance confidence (CONFbal scale)
6. Intrinsic motivation inventory scale
7. Romberg Test
8. SF-12
9. EuroQOL EQ-5D
Measured the start and at the end of the 12 week trial

Overall trial start date

01/03/2012

Overall trial end date

01/06/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Over the age of 65
2. Identified as at risk of falling by the Glasgow Falls Service
3. Living in the community
4. Able to perform home exercise
5. Able to give informed consent
6. Able to understand simple instructions using the English language (to understand instructions from visualizations/ games)

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

60

Participant exclusion criteria

1. Are unable to give informed consent
2. Have major cognitive impairments
3. Have major visual impairments
4. Have major aural impairments
5. Are unable to understand instructions in English (necessary to understand the instructions from the visualizations/ multimodal games)

Recruitment start date

01/03/2012

Recruitment end date

01/06/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Bioengineering Unit
Glasgow
G4 0NW
United Kingdom

Sponsor information

Organisation

Glasgow Caledonian University (UK)

Sponsor details

c/o Professor Douglas Greenhalgh
Cowcaddens Road
Glasgow
G4 0BA
United Kingdom
+44 (0)141 331 3000
D.A.Greenhalgh@gcu.ac.uk

Sponsor type

University/education

Website

http://www.gcu.ac.uk/

Funders

Funder type

Research council

Funder name

Medical Research Council (UK) - Lifelong Health and Wellbeing (Phase 2), ref: G0900583, Grant ID: 91021

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2013 protocol in http://www.ncbi.nlm.nih.gov/pubmed/23510162

Publication citations

  1. Protocol

    Uzor S, Baillie L, Skelton DA, Rowe PJ, Falls prevention advice and visual feedback to those at risk of falling: study protocol for a pilot randomized controlled trial., Trials, 2013, 14, 79, doi: 10.1186/1745-6215-14-79.

Additional files

Editorial Notes