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
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
-
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.