Condition category
Injury, Occupational Diseases, Poisoning
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
22/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Lalit Kalra

ORCID ID

Contact details

Guy's
King's
St Thomas' School of Medicine
Department of Medicine
King's Denmark Hill Campus
Bessemer Road
London
SE5 9PJ
United Kingdom
+44 (0)20 7346 3487
lalit.kalra@kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

REC00164

Study information

Scientific title

Acronym

Study hypothesis

A randomised control study will be undertaken in 200 patients over 60 years of age to investigate the feasibility, effectiveness and acceptability of a well-defined generalisable, mainstream physiotherapy intervention in improving mobility and preventing falls. Outcome will be measured at 1, 3 and 6 months. In addition to validated measures for balance, falls and mobility, assessments will be include measures of functional ability, quality of life, patients' perception of walking abilities and satisfaction. Information will also be available on effective components of balance training (which can be replicated in other settings) and identification of patients most likely to benefit which will facilitate targeting to improve overall effectiveness. The emphasis of the project is to develop and evaluate interventions deliverable within mainstream practice and applicable to mainstream patients.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Condition

Injury, occupational diseases, poisoning: Musculoskeletal injury

Intervention

1. Intervention group will receive therapy specific to functional balance consisting of repetition and progressive grading of tasks to narrow the base of support and retraining dynamic balance.
2. Conventional treatment will consist of general transfer and mobility skills as currently prescribed.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Timed 3 metre walk; Self Perception Questionnaire (SPQ); Berg Balance Scale (incorporating the 180 degree turn); Balance Performance Monitor (BPM); Falls Efficacy Scale; Frenchay Activities Index; Euroqual; patient satisfaction.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/05/1998

Overall trial end date

01/04/2001

Reason abandoned

Eligibility

Participant inclusion criteria

200 patients over 60 years of age who present with falls/deteriorating mobility to outpatient clinics, A & E departments and outpatients therapy services on 3 sites.

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

200

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

01/05/1998

Recruitment end date

01/04/2001

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Guy's, King's, St Thomas' School of Medicine
London
SE5 9PJ
United Kingdom

Sponsor information

Organisation

NHS R&D Regional Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive London (UK)

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

2003 results in http://www.ncbi.nlm.nih.gov/pubmed/12757574

Publication citations

  1. Results

    Steadman J, Donaldson N, Kalra L, A randomized controlled trial of an enhanced balance training program to improve mobility and reduce falls in elderly patients., J Am Geriatr Soc, 2003, 51, 6, 847-852.

Additional files

Editorial Notes