Falls Prevention for Visually Impaired Older People

September 2, 2019 updated by: Catherine Wood, Blind Veterans UK

Efficacy of a Tailored Exercise Programme and Home Evaluation for Falls Prevention in Older People With a Visual Impairment

This study aims to examine the effectiveness of an intensive five day falls prevention training programme with a home evaluation and a home exercise programme, compared with a home evaluation and exercise programme alone for reducing incidence of falls and fear of falling, and improving confidence in functional ability and objective balance.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

While previous research shows a clear link between visual impairment and increased risk and incidence of falls, as well as fear of falling, there is little research to investigate the effectiveness of falls prevention programmes for visually impaired populations. At the time of writing there were no studies identified that used this type of intensive training over a period of several days, rather most of the studies that exist have been conducted in community settings.

This study will aim to compare the effectiveness of a comprehensive exercise programme aimed at improving balance, walking technique, postural control and ability to complete functional tasks, with a home exercise programme with either written or audio instructions.

Study Type

Interventional

Enrollment (Anticipated)

32

Phase

  • 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 Contact

Study Contact Backup

Study Locations

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

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participant is able to mobilise with or without walking aids or hand-hold
  • Participant has history of falls
  • Any possible medical or pharmaceutical causes of falls have been investigated and excluded
  • Participant has a diagnosed visual impairment
  • Participant is aged 65 or over
  • Participant's falls can not be attributed purely to their visual impairment
  • Participant is a member of Blind Veterans UK
  • Participant is physically able to take part in group and individual exercise sessions
  • Participant is able to understand and follow verbal and/or written instructions

Exclusion Criteria:

  • Participant is under 65 years of age
  • Participant is medically unwell or has a medical condition for which exercise is contraindicated
  • Participant is currently involved in other falls prevention programmes
  • Participant is predominantly a wheelchair user
  • Participant is unable to understand or follow instruction from staff in English

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: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intervention group
This group will complete a 5 day falls prevention training programme, followed by a 12 week home exercise programme, then a repeat 5 day training intervention.
Other: 5 day falls prevention training
Intensive training on balance, gait re-education, functional activities, backwards chaining and postural control, completed at 0 and 12 weeks.
Other: Home exercise programme
A modified version of the Falls Management Exercise programme (FaME) provided in written or audio format and completed over 12 weeks.
Other: Environmental Assessment
Use of the Homefast assessment tool to reduce risk of falls at home.
ACTIVE_COMPARATOR: Comparison group[
This group will complete the home exercise programme only.
Other: Home exercise programme
A modified version of the Falls Management Exercise programme (FaME) provided in written or audio format and completed over 12 weeks.
Other: Environmental Assessment
Use of the Homefast assessment tool to reduce risk of falls at home.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Incidence of falls
Time Frame: Fortnightly reporting throughout the 12 week programme.
Participant's self-reported incidence of falls or near misses
Fortnightly reporting throughout the 12 week programme.
Change in Fear of falling
Time Frame: Completed at the time of consent to participate in the study and at week 0 and week 12 of the programme
The participant's self-reported level of fear about their risk of having a fall as indicated by completion of the Falls Efficacy Scale (FES-I), which scores from a minimum of 1 to a maximum of 4 on each item with a high score indicating a worse outcome. The lowest total score possible is 16 and the highest total score possible is 64.
Completed at the time of consent to participate in the study and at week 0 and week 12 of the programme
Change in Objective Balance
Time Frame: At 0 and 12 weeks in the programme
Standing balance as measured by the 4-point balance test
At 0 and 12 weeks in the programme

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risk of falls
Time Frame: Completed at the time of consent to participate in the study and at week 0 and 12 in the programme.
The participant's likelihood of experiencing a fall as measured by the Falls Risk Assessment Tool (FRAT), which scores from a minimum of 0 to a maximum of 5, with a higher score indicating a worse outcome.
Completed at the time of consent to participate in the study and at week 0 and 12 in the programme.
Confidence in functional ability
Time Frame: Completed at weeks 0 and 12 of the programme.
Self-reported confidence in ability to perform activities of daily living as recorded using the Activities-specific Balance Confidence (ABC) scale, which scores from a minimum of 0 to a maximum of 10 on each of the 16 items. An average is then taken from the scores, with a higher average indicating a better outcome.
Completed at weeks 0 and 12 of the programme.

Collaborators and Investigators

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

Sponsor

Blind Veterans UK

Investigators

  • Principal Investigator: Catherine Wood, MSc PT, Blind Veterans UK

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (ANTICIPATED)

January 1, 2020

Primary Completion (ANTICIPATED)

December 1, 2020

Study Completion (ANTICIPATED)

March 1, 2021

Study Registration Dates

First Submitted

August 30, 2019

First Submitted That Met QC Criteria

September 2, 2019

First Posted (ACTUAL)

September 6, 2019

Study Record Updates

Last Update Posted (ACTUAL)

September 6, 2019

Last Update Submitted That Met QC Criteria

September 2, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FPIS0.1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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 Fall

Clinical Trials on 5 day falls prevention training

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Japan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe